MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 01/VBHN-BYT | Hanoi, March 16, 2020 |
DECREE
ON MANAGEMENT OF MEDICAL DEVICES
Decree No. 36/2016/ND-CP dated May 15, 2016 of Government on management of medical devices coming into effect from July 1, 2016 is amended by:
1. Decree No.169/2018/ND-CP dated December 31, 2018 of Government on amendments to Decree No. 36/2016/ND-CP dated May 15, 2016 of Government on management of medical devices coming into effect from December 31, 2018.
2. Decree 03/2020/ND-CP dated January 1, 2020 of Government on amendments to Article 68 of Decree No. 36/2016/ND-CP dated May 15, 2016 of Government on management of medical devices which is amended by Decree No. 169/20181ND-CP dated December 31, 2018, coming into effect from January 1, 2020.
Pursuant to Law on Government Organization dated June 19, 2015; pursuant to Law on Investment dated November 26, 2014;
At the request of Minister of Health;
The Government promulgates Decree on management of medical devices. 1
Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Decree prescribes management of medical devices, including: classification of medical devices; manufacture, circulation, sale and provision of medical devices; information, labeling, management and use of medical devices in medical facilities.
Article 2. Term interpretation
1. 2 “Medical device” includes equipment, tools, materials, implant materials, reagents, in vitro calibration materials and software that simultaneously satisfy all following requirements:
a) Used independently or in combination with each other according to designation of owners of medical devices to serve humans for following purposes:
- Diagnosis, prevention, monitor, treatment and relief of diseases or injury compensation;
- Checking, replacement, modification or surgery and physiological process support;
- Life support or sustainment;
- Conception control;
- Sterilization of medical devices, including chemicals used during diagnosis;
- Provision of information for diagnosis, monitor and treatment via examination of specimens taken from the human bodies.
b) Not utilizing pharmacological, immune or metabolizing mechanisms in or on human bodies or utilizing said mechanisms to achieve purposes specified in Point a of this Clause.
2. “In vitro diagnostic medical device” consists of reagents, calibration materials, control materials, kits, machines, devices or systems that are used independently or in combination with each other as requested by owners thereof to serve examination of specimens taken from the human bodies.
3. “Component” refers to a product used by owners of medical devices for a particular purpose in combination with specific medical devices to facilitate or assist the devices to perform their intended purposes.
4. “Owners of medical devices” are organizations and individuals that:
a) Provide medical devices in their names or any brand, design, commercial name, other names or other codes under ownership or management of the individuals or organizations;
b) Are responsible for designing, manufacturing, assembling, processing, labeling, packaging, repairing or determining use purposes of the medical devices.
Article 3. Principles of managing medical devices
1. Ensure quality, safety and effectiveness of medical devices.
2. Adequately, accurately and promptly inform about technical specifications and use of medical devices and potential risks to the users.
3. Ensure traceability of medical devices.
4. Medical device management must be carried out based on classification of risk levels, national standards and national technical standards issued or accredited by competent regulatory agencies or declared and applied by organizations and individuals as per the law.
5. Medical devices that measure and/or radiate must be managed according to regulations and law on metrology, on atomic energy and this Decree.
Chemicals and preparations whose sole purpose is for disinfecting medical devices shall be managed according to this Decree. Chemicals and preparations that are used for disinfecting medical devices and other purposes shall be managed according to regulations and law on chemicals, pesticides and disinfectants used in domestic and medical contexts.
6. 3 Trade involving medical devices and manufacturing materials of medical devices containing narcotics and precursors must comply with regulations and law on narcotic prevention and counter in addition to regulations under this Decree.
Chapter II
CLASSIFICATION OF MEDICAL DEVICES4
Article 4. Types and principles of classifying medical devices
1. Medical equipment consisting of 2 categories shall be classified into 4 types based on level of hidden risks related to technical design and manufacture of the medical devices:
a) Category 1 consists of Type A medical devices which are medical devices with low risk level.
b) Category 2 consists of Type B, C and D medical devices, in which:
- Type B medical devices consist of medical devices with low to medium risk level;
- Type C medical devices consist of medical devices with medium to high risk level;
- Type D medical devices consist of medical devices with high risk level.
2. Principles of classifying medical devices:
a) Classification of medical devices must be performed based on risk levels and by facilities eligible for classifying medical devices as specified in this Decree;
b) With respect to medical devices that serve only 1 purpose which can be classified into 2 or more different risk levels, the highest risk level shall prevail;
c) With respect to medical devices that serve multiple purposes which are classified into different risk levels, the highest risk level shall prevail;
d) With respect to medical devices that are used in combination with other medical devices, each of the medical devices can be independently classified in terms of risk levels while final risk level shall be determined based on the highest risk level of the final use purpose of the combined medical devices.
3. Minister of Health shall elaborates on classification of medical devices satisfactory to international agreements on classification of medical devices of ASEAN in which Vietnam is a signatory.
Article 5. Facilities classifying medical devices
1. Classification of medical devices must be performed by eligible facilities as specified in Article 7 of this Decree.
2. Classifying facilities must rely on interpretations under Article 2 of this Decree, principles under Article 4 of this Decree, documents under Points e, g, h and i Clause 1 Article 26 of this Decree and classifying principles issued by Ministry of Health to classify medical devices.
3. Facilities that classify medical devices shall be responsible to the law for classification results of medical devices that they have classified.
4. In case of discrepancies in classification results of medical devices between classifying facilities, Ministry of Health shall decide classification of medical devices.
Article 6. Eligibility, application and procedures for issuance and revision of certificates for practicing medical device classification
1. Eligibility for applicants of certificates for practicing medical device classification (hereinafter referred to as “practising certificate”):
a) Having university education level or higher in technical, medical or pharmaceutical major;
b) Having involved in affairs directly related to medical devices for 24 months or higher within 48 months up to the date of application;
c) Having completed training courses regarding medical device classification according to training programs of Ministry of Health at medical facilities issued with codes for provision of continuous training.
2. Application and procedures for new issuance of practising certificates:
a) Application for new issuance of practising certificates:
- Written request for new issuance of practising certificates shall be prepared using form No. 17 under Annex I attached to this Decree;
- Master registers or certified true copies of university-level degrees or higher in technical, medical or pharmaceutical major. Degrees issued by foreign party must be recognized for equivalence by Ministry of Education and Training;
- Master registers or certified true copies of valid (3 years from date of signing) certificates of medical device training;
- 2 color photos with dimensions of 04 cm x 06 cm taken against a white background within 6 months up to the date of submission;
- Master registers or certified true copies of ID cards, Citizen Identity Cards or passports of the applicants;
- Master registers of copies of working period confirmation using form under Annex III attached to this Decree. In case a person performing medical device classification works at many different facilities and working period at any facility is less than 24 months, provide the confirmation of each facility to prove adequate working period satisfactory to Point b Clause 1 of this Article.
b) Procedures for new issuance of practising certificates:
- Within 20 days from the date on which complete applications are submitted, Ministry of Health shall appraise the applications;
- In case of satisfactory applications: within 10 working days from the date of appraisal, Ministry of Health shall issue practising certificates using Form 10 under Annex IV attached to this Circular and publicize following information on the website: practising certificates and applications therefor of individuals performing medical device classification.
- In case of unsatisfactory applications:
Within 5 working days from the date on which appraisal completes, Ministry of Health shall notice the applicants in writing to correct the applications. The written notice must specify all documents and details that need to be corrected;
Upon receiving documents requesting correction of the applications, the applicants must correct contents specified in the documents and submit revised applications to Ministry of Health. After receiving corrected applications, Ministry of Health shall appraise the applications as specified in this Clause;
In case of satisfactory correction: Ministry of Health shall issue practising certificates as specified in this Clause;
In case of unsatisfactory correction: Ministry of Health shall request the applicants to correct the applications.
Within 60 days from the date on which Ministry of Health issues written notice on correction, the applicants shall submit applications that have been corrected as requested. If the applicants fail to correct after the mentioned deadline or the corrected applications fail to meet the requirements after 03 months from the date on which the first applications are submitted, the submitted applications shall expire.
3. Applications and procedures for revision of contents of certificates for practicing medical device classification:
a) Applications for revision of contents of practising certificates:
- Written request for revision of contents of practising certificates shall be prepared using form No. 18 under Annex I attached to this Decree;
- Master registers or copies of documents proving changes in case of changes of administrative information: name, ID number, citizen identity number or passport number of individuals performing classification;
- Copies or certified true copies of certificates of medical device classification training in case of changing scope of operation or updating certificates of medical device classification training;
- Master registers of copies of working period confirmation using form under Annex III attached to this Decree. In case a person performing medical device classification works at many different facilities and working period at any facility is less than 24 months, provide the confirmation of each facility to prove adequate working period satisfactory to Point b Clause 1 of this Article.
b) Procedures for revision:
- Within 10 days from the date on which applications for revision are received, Ministry of Health shall appraise the applications;
- In case of satisfactory applications: Ministry of Health shall issue practising certificates using Form No. 11 under Annex IV attached to this Decree and update changed information on their website within 3 working days.
- In case of unsatisfactory applications:
Within 5 working days from the date on which appraisal records are produced, Ministry of Health shall inform the applicants in writing to correct the applications. The written notice must specify all documents and details that need to be corrected.
Upon receiving documents requesting correction of the applications, the applicants must correct contents specified in the documents and submit corrected applications to Ministry of Health. After receiving corrected applications, Ministry of Health shall appraise the applications as specified in this Clause.
In case of satisfactory applications, within 3 working days from the date on which appraisal records are produced, Ministry of Health shall revise practising certificates.
In case of unsatisfactory revision: Ministry of Health shall request the applicants to correct the applications.
Within 60 days from the date on which Ministry of Health issues written notice on correction, the applicants shall submit applications that have been corrected as requested. If the applicants fail to correct after the mentioned deadline or the corrected applications fail to meet the requirements after 03 months from the date on which the first applications are submitted, the submitted applications shall expire.
Article 7. Eligibility, documents and procedures for declaring eligibility for practicing medical device classification
1. Eligibility of facilities practising medical device classification (hereinafter referred to as “classifying facilities”): Have at least 1 person issued with the practising certificate.
2. Application for declaration of eligibility for practicing medical device classification consists of:
a) Declaration of eligibility for performing medical device classification using Form No. 01 under Annex I attached to this Decree;
b) Personnel declarations using form under Annex II attached to this Decision together with master registers or certified true copies of practising certificates of each individuals performing medical device classification whose name is included in the personnel declarations;
c) Master registers or certified true copies of business registration certificates of the facilities or investment certificates.
3. Procedures for declaring eligibility for practicing medical device classification:
a) Prior to classification of medical devices, facilities shall submit documents on declaration of eligibility for medical device classification as specified in Clause 2 of this Article to Ministry of Health;
b) Upon receiving satisfactory applications, Ministry of Health shall issue notice on receipt of documents on declaration of eligibility for medical device classification using Form No. 01 under Annex IV attached to this Decree;
c) Within 3 working days from the date written on the notice on receipt of documents on declaration of eligibility for medical device classification, Ministry of Health is responsible for publicizing following information on their website: name, address, phone number and scope of classifying facilities and application for declaration of eligibility for medical device classification.
4. Revision of contents of declarations of eligibility for practicing medical device classification:
a) Cases in which revision of contents of declarations of eligibility for practicing medical device classification is permitted:
- Change of individuals performing medical device classification when the replacements have the same scope of practice with the replaced individuals;
- Change of administrative information: address and phone number of classifying facilities; information about legal representatives of classifying facilities.
b) Applications for revision of contents of declarations of eligibility for practicing medical device classification:
- Applications for revision shall be produced using Form No. 19 under Annex I attached to this Decree, which must specify the changed details (including cases of informing that individuals performing classification no longer work at classifying facilities);
- In case of change of individuals performing classification: Master registers or certified true copies of practising certificates of the replacements sharing the same scope of operation with the replaced individuals;
- In case of change of administrative information: Documents proving changes of address and phone number of classifying facilities; information about legal representatives of classifying facilities.
c) Procedures for revision:
- Upon receiving applications for revision of contents of declarations of eligibility for medical device classification, Ministry of Health shall issue notice on receipt of applications for revision of declarations of eligibility for medical device classification using Form No. 13 under Annex IV attached to this Decree;
- Within 3 working days from the date specified on the notice on receipt of application for revision of contents of declaration of eligibility for medical device classification, Ministry of Health is responsible for updating changes on the websites of Ministry of Health. In case of rejection, produce written response and explanation.
5. Classifying facilities shall only perform medical device classification after being issued with notice on receipt of applications for revision of declarations of eligibility for medical device classification by Ministry of Health.
6. During operation process, classifying facilities must follow procedures for declaration of eligibility for performing medical device classification again in case of changes to individuals performing classification whose scope of operation is not included in the previously issued declarations of eligibility for medical device classification.
Article 8. Suspension of classification
1. Cases of suspension:
a) Perform medical device classification without declaring eligibility for performing medical device classification;
b) Use untrustworthy and/or inaccurate documents to declare eligibility for medical device classification.
d) Fail to satisfy requirements under Article 7 of this Decree;
d) Issue incorrect classification results thereby reducing risk levels of medical devices;
dd) Issue classification results which are signed by individuals who are not included in the notice on receipt of declarations of eligibility for medical device classification or not legal representatives;
e) Fail to adequately rectify consequences according to request of managing bodies;
g) Fail to publicize classification results as specified in Point c Clause 5 Article 66 and Clause 8 Article 68 of this Decree.
2. Procedures for suspension:
a) If classifying facilities or individuals performing classification committing any of the violations under Clause 1 of this Article are inspected and discovered, inspecting authorities are responsible for producing records using form under Annex XII attached to this Decree and propose competent agencies to request the classifying facilities or individuals performing classification to suspend classification of medical devices and send the records to Ministry of Health within 24 hours after the records are completed;
b) Within 24 hours after receiving the records, Ministry of Health is responsible for informing Health Departments, General Department of Customs and customs departments at border checkpoints to suspend processing of documents related to medical devices that utilize classification results specified in the records until official conclusions of Ministry of Health are issued and Ministry of Health shall request the classifying facilities to provide explanation for affairs specified in the records;
c) Within 3 working days after receiving explanation of classifying facilities, Ministry of Health is responsible for assessing the explanation of classifying facilities;
d) In case of accepting the explanation of classifying facilities and no requirements for rectifying measures, Ministry of Health is responsible for issuing notice on termination of classification suspension. Documents terminating classification suspension shall be sent to classifying facilities, Health Departments, General Department of Customs and customs departments of border checkpoints and uploaded on website of Ministry of Health;
dd) In case of accepting the explanation of classifying facilities and requirements for rectifying measures, Ministry of Health is responsible for issuing the classifying facilities with notice to enable rectification. These documents shall be sent to classifying facilities, Health Departments, General Department of Customs and customs departments of border checkpoints and uploaded on website of Ministry of Health;
Suspended classifying facilities must report to Ministry of Health in writing after finishing the rectification.
Within 3 working days after receiving reports on rectification of suspended classifying facilities, Ministry of Health shall issue documents terminating classification suspension, request continuous implementation of rectification measures or follow revocation procedures under Article 9 of this Decree. These documents shall be sent to classifying facilities, Health Departments, General Department of Customs and customs departments of border checkpoints and uploaded on website of Ministry of Health.
e) In case of rejecting explanation of classifying facilities, Ministry of Health is responsible for issuing documents requesting agencies receiving declarations of eligibility for classification to follow procedures for revocation under Article 9 and dispose medical devices that utilize revoked classification results under Article 10 of this Decree.
Article 9. Revocation of notice on receipt of declarations of eligibility for medical device classification, practising certificates and results of medical device classification
1. Revocation of notice on receipt of declarations of eligibility for practicing medical device classification:
a) Cases of revocation:
- Falsification of contents in declarations of eligibility for performing medical device classification;
- Failure to comply with Clause 1 Article 7 of this Decree;
- Issuance of classification results while being suspended;
- Issuance of classification results which reduce risk levels of medical devices for the second time in 12 months;
- Failure to adequately rectify consequences according to request of managing bodies.
b) Revocation procedures:
- Within 1 working day after conclusions on classifying facilities committing any of the violations under Point a of this Clause, Ministry of Health is responsible for issuing documents on revoking notice on receipt of declarations of eligibility for performing medical device classification, which specify rectifying measures (if any) and remove all information about the classifying facilities revoked from notice on receipt of declarations of eligibility for performing medical device classification on their website.
Documents on revocation of notice on receipt of declarations of eligibility for performing medical device classification shall be sent to classifying facilities, Health Departments, General Department of Customs and customs departments of border checkpoints and uploaded on website of Ministry of Health;
- After receiving documents on revocation of notice on receipt of declarations of eligibility for performing medical device classification of Ministry of Health, classifying facilities are responsible for immediately ceasing classification of medical devices and adopting rectifying measures (if any) and responsible for dealing with consequences caused by their illegal conducts;
- In case classifying facilities fail to adequately comply with documents on revocation of notice on receipt of declarations of eligibility for performing medical device classification, Ministry of Health is responsible for transferring the documents to other competent agencies for continuous implementation as per the law.
2. Revocation of practising certificates:
a) Cases of revocation:
- Falsification of contents in practising certificates;
- Classification of medical devices unsatisfactory to this Decree.
- Classification and issuance of results thereof with expired certificates of medical device classification training;
- Incorrect classification results which reduce risk levels of medical devices for the second time in 12 months;
- Classification and issuance of classification results while being suspended; including cases in which classifying facilities where individuals performing medical device classification are working are suspended or revoked from notice on receipt of declarations of eligibility for performing medical device classification.
b) Procedures for revocation of practising certificates:
- Within 1 working day from the date on which conclusions regarding individuals performing classification committing any of the violations under Point a of this Clause are produced, Ministry of Health is responsible for issuing documents on revocation of practising certificates, which must require classifying facilities where the individuals are working to adopt measures to rectify consequences caused by the individuals (if any) while removing information of the individuals from website of Ministry of Health.
Documents on revocation of practising certificates shall be sent to classifying facilities where the individuals subject to the documents are working, Health Departments, General Department of Customs and customs departments of border checkpoints and uploaded on website of Ministry of Health.
- After receiving documents on revocation of practising certificates, individuals performing classification and classifying facilities where they are working are responsible for immediately ceasing classification of medical devices and adopting rectifying measures (if any) and responsible for dealing with consequences caused by their illegal conducts;
- In case individuals performing classification and classifying facilities fail to adequately comply with documents on revocation of practising certificates, Ministry of Health shall adopt procedures for revoking notice on receipt of declarations of eligibility for classification and transferring the cases to other competent agencies for continuous implementation as per the law.
3. Revocation of classification results:
a) Cases of revocation:
- Incorrect classification results thereby reducing risk levels of medical devices;
- Signing of classification results by individuals who are not included in the notice on receipt of declarations of eligibility for medical device classification or not legal representatives of classifying facilities;
- Fabricated classification results;
- Issuance of classification results while classifying facilities are being suspended or revoked from notice on receipt of declarations of eligibility for performing classification.
b) Revocation procedures:
- Within 1 working day from the date on which conclusions regarding classification results failing under any of the cases under Point a of this Clause are produced, Ministry of Health is responsible for issuing documents on revocation of classification results, which must require classifying facilities to adopt measures to rectify consequences caused by the violations (if any) while removing information of the revoked medical devices from website of Ministry of Health.
Documents on revocation of classification results shall be sent to classifying facilities, Health Departments, General Department of Customs and customs departments of border checkpoints and uploaded on website of Ministry of Health.
- After receiving documents on revocation of classification results, classifying facilities are responsible for revoking all classification results specified in the documents and dealing with consequences caused by their illegal conducts;
In case classifying facilities fail to adequately comply with documents on revocation of classification results, Ministry of Health shall adopt procedures for revoking notice on receipt of declarations of eligibility for classification and transferring the cases to other competent agencies for continuous implementation as per the law.
- After receiving documents on revocation of classification results, agencies receiving declarations of applied standards or requesting issuance of registration number (hereinafter referred to as “documents on issuance of registration number”) are responsible for reviewing registration number issued under their management. In case of discovering medical devices issued with registration number that utilize classification results revoked by Ministry of Health, agencies issuing registration number are responsible for revoking the registration number of the medical devices.
Article 10. Disposing medical devices that utilize revoked classification results
1. In case medical devices currently subject to procedures for issuance of registration number utilize classification results which are subject to documents on revocation by Ministry of Health:
a) Organizations and individuals applying for declaration of applied standards or issuance of registration of number are responsible for reporting to agencies receiving applications for issuance of registration number to cease issuance of registration number;
b) After receiving written request of agencies and organizations specified in Point a of this Clause or after receiving documents on revoking classification results of medical devices, receiving agencies are responsible for rejecting issuance of registration number.
2. In case medical devices which are subject to issuance of registration number and utilizing classification results which are subject to documents on revocation by Ministry of Health but not customs clearance:
a) Holders of registration number are responsible for ceasing adoption of procedures for customs clearance, reporting to customs departments of border checkpoints where customs clearance are to be performed to cease customs clearance procedures and agencies issuing registration number to revoke the registration number;
b) After receiving request of holders of registration number or after receiving documents on revocation of classification results of medical devices, customs authorities are responsible for ceasing customs clearance procedures; agencies issuing registration number are responsible for adopting procedures for revoking registration number.
3. In case of medical devices which are issued with registration number, having classification results subject to documents on revocation of Ministry of Health and granted customs clearance by not sold to customers:
a) Holders of registration number are responsible for:
- Ceasing circulation of medical devices and adopting measures to revoke medical devices whose registration number utilizes classification results subject to documents on revocation of Ministry of Health according to application for issuance of registration number;
- Reporting to customs authorities that granted clearance, specifying quantity of medical devices that is granted customs clearance and requesting to cease import procedures for subsequent shipments;
- Reporting to agencies issuing registration number, quantity of medical devices that is granted customs clearance and purchase agreements (if any);
- Adopting procedures for applying for registration number again.
b) After receiving written request of holders of registration number of documents on revocation of classification results of medical devices:
- customs authorities are responsible for rejecting granting customs clearance;
- Agencies that issue registration number are responsible for adopting procedures for revoking the registration number.
4. In case of medical devices sold to health facilities:
a) Holders of registration number are responsible for:
- Reporting quantity of medical devices that is sold to health facilities to agencies issuing registration number;
- Informing health facilities that are utilizing medical devices in writing.
b) In case of medical devices which are issued with registration number and utilizing incorrect classification results without posing possibilities of harming patients: Health facilities may continue to use the medical devices and holders of registration number are responsible for revising registration of medical devices at health facilities as soon as issued with new registration number;
b) In case of medical devices which are issued with registration number and utilizing incorrect classification results without posing possibilities of harming patients: Health facilities may continue to use the medical devices and holders of registration number are responsible for revising registration of medical devices at health facilities as soon as issued with new registration number;
Chapter III
MANUFACTURE OF MEDICAL DEVICES
Article 11. Investment incentives for medical device manufacture
1. Reduction or exemption from land rents of the Government:
a) Investors having projects of manufacturing Type B medical devices when hiring land of the Government shall benefit from the lowest price specified by People’s Committees of provinces and central-affiliated cities (hereinafter referred to as “Provincial People’s Committees”) and exempt from land rents as per the law;
b) Investors having projects of manufacturing Type C and/or D medical devices shall be exempted from land rents from the date on which the projects function;
c) Investors having projects of manufacturing medical devices shall be exempted from land rents for land for construction of residential buildings for workers, land for planting trees and land for public benefits.
2. Apart from incentives under Clause 1 of this Article, projects of manufacturing medical devices shall receive other investment incentives according to regulations and law on investment, science and technology.
Article 12. Personnel requirements of medical device manufacturing facilities
1. Requirements of specialized individuals:
a) 5 Have qualifications specified in medical device technology of college level or higher or have qualifications specified in technique or medicine of university level or higher. In case of facilities manufacturing medical device containing narcotics and precursors, specialized individuals must have bachelor’s degrees in medical devices, medicine, pharmacy, chemical or biology;
b) Have experience in operating in technical of medical device in health facilities for least 24 months;
c) Work full time at manufacturing facilities. Assignment and designation of specialized individuals of manufacturing facilities must be specified in writing.
2. 6 (annulled).
Article 12. Quality control requirements of medical device manufacturing facilities7
1. Satisfy quality control systems according to Clause 1 Article 68 of this Decree.
2. With respect to facilities manufacturing medical devices that contain narcotics and precursors, in addition to regulations under Clause 1 of this Article, install systems for monitoring and managing input, output, storage, use of materials that are narcotics and precursors, input, output and storage of medical devices that contain narcotics and precursors and warehouses satisfactory to Article 7 of Decree No. 80/2001/ND-CP dated November 5, 2001 of Government providing guidelines for controlling legal domestic activities related to narcotics (hereinafter referred to as “Decree No. 80/2001/ND-CP”).
Article 14. Declarations of eligibility for manufacturing medical devices
Declarations of eligibility for manufacturing medical devices consist of:
1. Declarations of eligibility for manufacturing medical devices using Form No. 02 under Annex I attached to this Decree.
2. Declaration of personnel using form under Annex II attached to this Decree.
3. Documents on assignment and designation of specialized individuals of manufacturing facilities together with working period confirmation using form under Annex III attached to this Decree and training certificates and degrees of the specialized individuals.
4. 8 Certificate of conformity with quality control standards accredited by conformity assessment bodies as per the law.
In case facilities that cannot perform quality control, do not have warehouses or transports sign contracts for quality control, preservation and transportation with other facilities, attach documents proving capacity for conducting quality control, storing and transporting medical devices that they manufacture.
5. 9Documents proving satisfaction to Clause 2 Article 13 of this Decree.
Article 15. Requirements for declarations of eligibility for manufacturing medical devices
1. Declarations of eligibility for manufacturing medical devices shall be compiled into a set, in which:
a) Contents in the set must be printed clearly and arranged in order specified in Article 14 of this Decree; sections must be separated in-between with covers and tables of contents;
b) Documents that are not in English must be translated into Vietnamese.
2. Requirements for contents of declarations of eligibility for manufacturing:
a) Master registers or certified true copies of documents on assignment, designation, certificates and training degrees of specialized individuals of manufacturing facilities;
b) 10 (annulled).
c) Master registers, certified true copies or confirmed copies of Certificate of conformity with quality control standards of facilities applying for declaration of manufacturing eligibility.
Article 14. Procedures for declaring eligibility for manufacturing medical devices11
1. A facility shall only manufacture medical devices after being issued with notice on receipt of declarations of eligibility for manufacturing by Heath Departments as specified in Point b Clause 2 of this Article.
2. Procedures for declaring eligibility for manufacturing:
a) Prior to manufacturing medical devices, the manufacturing facility is responsible for submitting declarations of eligibility for manufacturing according to Article 14 of this Decree to Health Department where the facility is situated;
b) Upon receiving satisfactory documents, Health Department shall issue the applicants with notice on receipt of declarations of eligibility for manufacturing using Form No. 02 under Annex IV attached to this Decree. In case a facility declares manufacture of medical devices containing narcotics and precursors, Health Department is responsible for submitting copies of notice on receipt of declarations of eligibility for manufacture to Ministry of Public Security.
3. Revision of contents of declarations of eligibility for manufacturing medical devices:
a) Cases in which revision of contents of documents on declaring eligibility for manufacturing medical devices is permitted:
- Change of specialized individuals of manufacturing facilities;
- Change of address and/or phone number.
b) Applications for revision of contents of declarations of eligibility for manufacturing medical devices:
- Written request for revision of shall be prepared using Form No. 20 under Annex I attached to this Decree, which specifies the changes;
- In case of changes in specialized individuals: Documents specified in Clause 3 Article 14 of this Decree;
- In case of changes in address and/or phone number; Documents proving such changes of manufacturing facilities.
c) Procedures for revision:
- Upon receiving applications for revision of contents of declaration of eligibility for manufacturing medical devices, Health Department shall issue notice on receipt of application for revision of declarations of eligibility for manufacturing medical devices using Form No. 14 under Annex IV attached to this Decree;
- Within 3 working days from the date specified on the receipt notice, Health Department is responsible for updating changes on the website. In case of rejection, produce written response and explanation.
4. During operation process, manufacturing facilities must follow procedures for declaring eligibility for manufacturing again if any changes related to previously declared documents that are not specified in Point a Clause 3 of this Article occur.
5. In case a manufacturing facility changes manufacturing site from a province to another, inform Health Department where they have declared eligibility for manufacturing within 10 working days from the date on which manufacturing site is changed.
Within 3 working days from the date on which notice on changes to manufacturing site of the manufacturing facility is received, the Health Department is responsible for ceasing upload of information related to that facility.
Chapter IV
CIRCULATION OF MEDICAL DEVICES
Section 1. REQUIREMENTS FOR CIRCULATION, REGISTRATION NUMBER AND REQUIREMENTS FOR ORGANIZATIONS DECLARING APPLICABLE STANDARDS OR CONDUCTING REGISTRATION
Article 17. Circulation requirements of medical devices
1. Medical devices to be circulated must satisfy following requirements:
a) 12 Having registration number or having obtained permission for import according to this Decree, other than medical gas;
b) Having label or supplementary label containing sufficient information specified in Article 54 of this Decree;
c) Having technical documents serving the repair and maintenance of medical devices, excluding disposable medical devices prescribed by its owners;
d) Having Vietnamese instruction of how to use the medical devices;
dd) 13 Having information about warranty establishments, conditions and duration, except for disposable medical devices decided by its owner or medical devices subject to documents proving no warranty required;
2. In case of information specified in Points c, d and dd Clause 1 of this Article is not attached to medical devices, provide in form of electronic information and clearly describe methods of looking up information on labels of medical devices.
Article 18. Requirements for declaration of applicable standards or issuance of certificate of registration of medical devices
1. Requirements for declaration of applicable standards or issuance of certificate of registration of medical devices:
a) The medical devices must be manufactured by a manufacturing facility that has declared eligibility for manufacturing domestic medical devices;
b) The medical devices must be manufactured by a manufacturing facility that has been issued with certificate of conformity with quality control standards and must be permitted for circulation at any state in case of import medical devices;
c) The medical devices must conform to national technical regulations or standards declared for application by the manufacturer thereof.
2. Procedures for declaring applicable standards or registering circulation of medical devices are prohibited if:
a) The medical devices are mentioned under Clause 1 Article 34 of this Decree; or
b) The medical devices are revoked as specified in Clauses 1 and 3 Article 35 of this Decree.
3. Do not receive applications for declaring applicable standards or registering circulation within 12 months from the date on which decisions on revocation of registration number of medical devices mentioned in Clauses 2 and 8 Article 35 of this Decree are issued.
Article 19. Medical devices exempted from declaring applicable standards and registering circulation
1. Medical devices solely used for research, experiments, use instructions and repair of medical devices.
2. Medical devices imported to Vietnam for assistance, serving carnivals, exhibits, display, product launch events or to be gifted, awarded or granted.
3. Medical devices manufactured in Vietnam solely for export or exhibit, carnival or display in foreign countries.
Article 20. Registration number of medical devices
1. Registration number of medical devices is:
a) In case of Type A medical devices, number of notice on receipt of declaration of applicable standards using Form No. 3 under Annex IV attached to this Decree.
b) In case of Type B, C or D medical devices, number of certificate of registration using Form No. 9 under Annex IV attached to this Decree.
2. Registration number of medical devices can be issued for one or a group of medical device type.
3. Holders of registration number are organizations declaring applicable standards in case of Type A medical devices or organizations issued with registration number in case of Type B, C or D medical devices.
4. Effective period of registration number:
a) Registration number of Type A medical devices is effective indefinitely;
b) Registration number of Type B, C or D medical devices is effective for 5 years from date of issue. In case effective period of registration number of medical devices is extended, the previously issued registration number shall be retained.
Article 21. Requirements for organizations declaring applicable standards or registering circulation of medical devices
1. Organizations declaring applicable standards or registering circulation of medical devices include:
a) Vietnamese enterprises, cooperatives and household businesses that own medical devices;
b) Vietnamese enterprises, cooperative and household businesses that trade medical devices and are authorized by owners of medical devices to register;
c) Standing representative offices in Vietnam of foreign traders who own medical devices or are authorized by owners of medical devices.
2. Any organization declaring applicable standards or registering for circulation of medical devices must have warranty establishments in Vietnam or sign a contract with an organization capable of providing warranty services on medical devices which are registered in the organization’s name, except for disposable medical devices prescribed by the owners thereof.
In case an organization declaring applicable standards or registering for circulation of medical devices falls under cases specified in Point c Clause 1 of this Article, owners of the medical devices must have warranty establishments or sign a contract with an organization capable of providing warranty services on medical devices which are registered in the owners’ name, except for disposable medical devices as prescribed by the owners thereof.
Warranty establishments must the certified by owners of medical devices to be capable of providing warranty services for products registered by the organizations.
Section 2. DECLARATION OF APPLICABLE STANDARDS OF TYPE A MEDICAL DEVICES
Article 22. Application for declaration of applicable standards14
Applications for declaration of applicable standards of Type A medical devices include:
1. Documents declaring applicable standards of Type A medical devices using Form No. 3 under Annex I attached to this Decree.
2. Classification results of medical devices using forms under Annex V attached to this Decree.
3. Valid certificates of conformity with quality control standards at the time of application. In case of domestically manufactured medical devices, notice on receipt of declarations of eligibility for manufacturing medical devices is also required.
4. Power of attorney of owners of medical devices for organizations declaring applicable standards using forms under Annex VI attached to this Decree that is valid at the time of application, except for cases specified in Point a Clause 1 Article 21 of this Decree.
5. Certificate of warranty capability issued by owners of medical devices using forms under Annex VII attached to this Decree, except for disposable medical devices prescribed by owners thereof or cases in which warranty services are not required.
6. Documents providing brief specification of medical devices in Vietnamese using Form No. 1 under Annex VIII attached to this Decree together with technical documents describing technical functions and figures of the medical devices issued by owners of the medical devices.
With respect to reagents, calibration materials and in vitro control materials, technical documents in Vietnamese using Form No. 2 under Annex VIII attached to this Decree together with documents on materials and safety of products, manufacturing process, clinical and paraclinical studies including stability reports.
7. Certificates of conformity as per the law or product standards publicized by owners of medical devices together with assessment results of chemical, physical, microbial figures and other figures provided by facilities eligible for performing conformity assessment for domestically manufactured medical devices. Assessment results must conform to standards publicized by the owners.
8. Written instruction of medical devices.
9. Samples of labels of medical devices to be used during circulation in Vietnam.
10. Certificates of free sale that are valid at the time of application in case of import medical devices.
Article 23. Requirements for declaration of applicable standards
1. Declaration for applicable standards shall be prepared into 1 set.
2. Requirements for contents of declaration for applicable standards:
a) With respect to notice on receipt of declarations of eligibility for manufacturing: Submit copies confirmed by organizations declaring applicable standards.
b) 15 With respect to certificates of conformity with quality control standards: Submit master registers, certified true copies or copies confirmed by organizations declaring applicable standards;
In case of certificates of conformity with quality control standards that are in languages other than English or Vietnamese, translate the certificates into Vietnamese. The translations must be authenticated as per the law.
c) With respect to power of attorney of owners of medical devices and certificates of warranty eligibility:
- With respect to domestically manufactured medical devices: Submit master registers or certified true copies;
- With respect to import medical devices: Submit consular legalized version or verified true copies thereof.
d) With respect to certificates of conformity or Standards declared for application by owners of medical devices: Submit copies confirmed by owners declaring applicable standards.
In case of Standards that are in languages other than English or Vietnamese, translate into Vietnamese. The translations must be authenticated as per the law;
dd) With respect to use instruction of medical devices: Submit Vietnamese translation thereof confirmed by organizations declaring applicable standards;
e) With respect to label samples: Submit samples of labels confirmed by organizations declaring applicable standards. Label samples must satisfy requirements under Article 54 of this Decree.
g) 16 With respect to certificates of free sale: Submit consular legalized version or verified true copies thereof.
In case of certificates of free sale that are in languages other than English or Vietnamese, translate the certificates into Vietnamese. The translations must be authenticated as per the law.
With respect to certificates of free sale that do not specify expiry date, the certificates of free sale shall expire after 36 months from the date of issue.
Article 24. Procedures for declaring applicable standards
1. Type A medical devices shall only be circulated after being issued with notice on receipt of declarations of applicable standards by Health Department as specified in Point b Clause 2 of this Article.
2. Procedures for declaring applicable standards
a) Prior to allowing circulation of Type A medical devices, facilities responsible for introducing the medical devices to the market are obliged to send declarations of applicable standards as specified in Article 22 of this Decree to Health Departments where the manufacturing facilities are based;
b) Upon receiving satisfactory documents, Health Departments shall issue notice on receipt of declarations of applicable standards using Form No. 03 under Annex IV attached to this Decree;
c) Within 3 working days from the date specified on the notice receipt, Health Departments are responsible for publicizing following information on their website: name, classification, manufacturing facilities and manufacturing countries of medical devices; registration number of medical devices; name and address of owners of medical devices; name and address of holders of registration number; name and address of facilities providing warranty services for medical devices and declarations of applicable standards of medical devices.
3. In case of changes to owners of medical devices; name, manufacturing facilities and manufacturing countries of medical devices, holders of registration number are responsible for declaring applicable standards according to this Decree again.
4. 17During circulation of medical devices, holders of registration number are responsible for informing agencies issuing registration number within 10 working days from the date on which any of following changes occurs:
a) Changes to address of owners of medical devices or holders of registration number of medical devices; or
b) Changes to name of holders of registration number. Holders of registration number are responsible for sending notice together with evidence documents and label samples as specified in Article 54 of this Decree; or
c) Changes to either name or address of manufacturing facilities of medical devices. Holders of registration number are responsible for attaching following documents to notice on changes: certificates of free sale and certificates of conformity with quality control standards that are valid at the time of submission; or
d) Changes to packing methods of in vitro diagnostic materials. Holders of registration number are responsible for attaching documents specified in Clauses 6 and 9 Article 22 of this Decree to notice on changes; or
dd) Changes to facilities providing warranty services. Holders of registration number are responsible for attaching documents specified in Clause 5 Article 22 of this Decree to notice on changes; or
e) Changes to labels or use instructions without any change to designation. Holders of registration number are responsible for attaching documents on the changes to notice on the changes.
Section 3. CIRCULATION REGISTRATION FOR TYPE B, C OR D MEDICAL DEVICES
Article 25. Form of circulation registration18
1. New issuance of registration number for medical devices in following cases:
a) Medical devices to be issued with registration number for the first time;
b) Medical devices issued with registration number and experiencing any of following changes: Type of medical devices; manufacturing materials that functionally impact in vitro diagnostic materials and disposable medical devices;
c) Medical devices issued with registration number which is not registered for extension within the time limit specified in Clause 3 Article 27 of this Decree.
2. Immediate issuance of registration number for medical devices in following cases:
a) Medical devices circulated in at least 2 of following countries: Japan, Canada, Australia, United States and member states of the EU;
b) Medical devices circulated in Vietnam prior to December 31, 2018 and satisfying following requirements:
- Circulated for at least 3 years within 5 years prior to the date of application;
- No warnings related to quality and safety of the medical devices.
3. Extension of registration number in case of registration number that is about to expired according to Clause 3 Article 27 of this Decree.
Article 26. Application for new issuance of registration number
1. 19Application for new issuance of registration number of medical devices that are not issued with corresponding national technical regulations:
a) Application for new issuance of practising certificates prepared by using form No. 04 under Annex I attached to this Decree;
b) Classification of medical devices prepared by using forms under Annex V attached to this Decree;
c) Certificates of conformity with quality control standards valid at the time of application;
d) Power of attorney of owners of medical devices for organizations applying for circulation using forms under Annex VI attached to this Decree that is valid at the time of application, except for cases specified in Point a Clause 1 Article 21 of this Decree;
dd) Certificate of warranty capability issued by owners of medical devices using forms under Annex VII attached to this Decree, except for disposable medical devices prescribed by owners thereof or cases in which warranty services are not required;
e) Certificates of free sale that are valid at the time of application in case of import medical devices;
g) Documents providing brief specification of medical devices in Vietnamese using Form No. 1 under Annex VIII attached to this Decree together with technical documents describing technical functions and figures of the medical devices issued by owners of the medical devices;
With respect to reagents, calibration materials and in vitro control materials, technical documents in Vietnamese using Form No. 2 under Annex VIII attached to this Decree together with documents on materials and safety of products, manufacturing process, clinical and paraclinical studies including stability reports;
h) Common technical documents following guidelines under ASEAN Meeting on medical devices;
i) Written instruction of medical devices;
k) In case of Type C or D medical devices that infiltrate human body: Summary of clinical tests using forms under Annex IX attached to this Decree together with results of clinical test, except for following cases:
- Medical devices circulated and issued with certificates of free sale by any of following countries: member states of the EU, Japan, Canada, Australia (TGA), United States (FDA);
- Medical devices circulated prior to effective date of this Decree;
- Other cases prescribed by Minister of Health.
l) Type C or D in vitro diagnostic medical devices also require verification certificates of Ministry of Health, except for following cases:
- Medical devices issued with certificates of free sale by any of following countries: member states of the EU, Japan, Canada, Australia (TGA), United States (FDA);
- Medical devices circulated prior to effective date of this Decree;
m) Samples of labels of medical devices to be used during circulation in Vietnam;
n) Notice on receipt of declarations of eligibility for manufacturing satisfactory to products applied for registration number in case of domestically manufactured medical devices;
o) Income statement for the period in which registration number is issued using Form No. 01 under Annex X attached to this Decree in case of medical devices that are circulated prior to effective date of this Decree and exempted from submission of summary of clinical test data or verification certificates.
2. Application for new issuance of registration number of medical devices that are issued with corresponding national technical regulations:
a) Application for new issuance of registration number shall be prepared using Form No. 04 under Annex I attached to this Decree;
b) Certificates of conformity;
c) 20 Documents specified in Points b, c, d, dd, e, g, h, i, m, n and o Clause 1 of this Article.
3. Applications for new issuance of medical devices that are measuring instruments that must approve samples according to metrology laws:
a) Application for new issuance of registration number shall be prepared using Form No. 04 under Annex I attached to this Decree;
b) Decision on sample approval;
c) 21 Documents specified in Points b, c, d, dd, e, g, h, i, m, n and o Clause 1 of this Article.
4. Applications for new issuance of medical devices that are measuring instruments that do not have to approve samples according to metrology laws shall comply with Clause 1 of this Article.
5. 22Application for immediate issuance of registration number:
a) With respect to cases specified in Point a Clause 2 Article 25;
Documents specified in Clause 1 of this Article and at least 1 additional certificate of free sale issued by competent agencies of any of following states: member states of the EU, Japan, Canada, Australia (TGA) or the United States that are valid at the time of submission;
b) With respect to cases specified in Point b Clause 2 Article 25;
Documents specified in Clause 1 of this Article and following documents:
- At least 3 contracts for provision of medical devices for health facilities in Vietnam;
- Confirmation documents of health facilities regarding medical devices lacking warnings related to quality and safety during use.
Article 27. Application for issuance and extension of registration number
1. Application for issuance of registration in case of loss or damage: Written application for issuance of registration number using Form No. 5 under Annex I attached to this Decree.
2. Application for extension of registration number includes:
a) Application for extension of registration number shall be prepared using form No. 06 under Annex I attached to this Decree;
b) Copies of issued certificates of circulation registration;
c)23 Certificates of conformance with quality control standards valid at the time of application;
d) Power of attorney of owners of medical devices for organizations applying for circulation using forms under Annex VI attached to this Decree, except for cases specified in Point a Clause 1 Article 21 of this Decree;
dd) Certificates of free sale that are valid at the time of application in case of import medical devices;
e) Income statement for the period issued with registration number prepared using forms under Annex X attached to this Decree;
g)24 Common technical documents following guidelines of ASEAN Meeting on medical devices for cases in which registration number has been issued and ASEAN Common technical documents are not required at the time of issuance as per the law.
3. Application for extension of registration number must be submitted at least 60 days before expiry date.
Article 28. Requirements for application of new issuance or extension of registration number
1. Applications for new issuance or extension of registration number shall be made into 1 document whose contents must be clearly printed and arranged in order specified in Article 26 of this Decree in case of applications for new issuance of registration number or in Clause 2 Article 27 of this Decree in case of applications for extension of registration number; contents must be separated, have covers and tables of contents.
2. Requirements for contents of the applications:
a)25 In case of certificates of conformance with quality control standards: Submit master registers, certified true copies or confirmed copies of facilities applying for issuance of registration number.
In case of certificates of conformance with quality control standards that are in languages other than English or Vietnamese, translate the certificates into Vietnamese. The translations must be authenticated as per the law.
b) With respect to power of attorney of owners of medical devices and certificates of warranty eligibility:
- With respect to domestically manufactured medical: Submit master registers or certified true copies;
- With respect to import medical devices: Submit consular legalized version or verified true copies thereof.
c) With respect to certificates of free sale: Submit consular legalized version or verified true copies thereof.
In case of certificates of free sale that are in languages other than English or Vietnamese, translate into Vietnamese. The translations must be authenticated as per the law.
With respect to certificates of free sale that do not specify expiry date, the certificates of free sale shall expire after 36 months from the date of issue.
d) With respect to technical documents of medical devices: Submit documents confirmed by organizations applying for issuance of registration number.
In case of technical documents that are in languages other than English or Vietnamese, translate into Vietnamese. The translations must be authenticated as per the law;
dd) With respect to use instruction of medical devices: Submit Vietnamese translation thereof confirmed by organizations applying for issuance of registration number.
e)26 In case of certificates of conformance with quality control standards: Submit master registers, certified true copies or confirmed copies of facilities applying for issuance of registration number.
g) In case of label samples: Submit label samples confirmed by organizations registering for circulation. Label samples must satisfy requirements under Article 54 of this Decree.
Article 29. Receipt and appraisal of applications for circulation of medical devices
1. Organizations applying for issuance of registration number shall apply at Ministry of Health.
2. After receiving application for circulation, Ministry of Health shall send notice on receipt of application for circulation of medical devices using Form No. 4 under Annex IV attached to this Decree to the applicants. Do not receive the applications in case they fail to satisfy requirements under Article 28 of this Decree.
3. In case of no revision to the applications required, Minister of Health is responsible for:
a) In case of medical devices that do not have corresponding national technical regulations: organizing appraisal to issue new registration number within 60 days or extend registration number within 30 days from the date specified on the receipt notice. In case of rejection, provide written response and explanation;
b) In case of medical devices that already have corresponding national technical regulations: organizing appraisal to issue new registration number within 15 days or extend registration number within 10 days from the date specified on the receipt notice. In case of rejection, provide written response and explanation;
c) Issuing another registration number within 5 working days from the date specified on the receipt notice. In case of rejection, provide written response and explanation;
d)27 Organizing appraisal to issue new registration number within 30 days from the date specified on the receipt notice for cases under Clause 2 Article 25 of this Decree.
4. In case of incomplete applications for circulation, Ministry of Health must inform the applicants in writing to revise the applications by specifying documents and contents that must be revised within:
a) 15 working days from the date specified on the receipt notice of applications for new issuance or extension of registration number;
b) 05 working days from the date specified on the receipt notice of applications for issuance of another registration number;
5. 28 After receiving documents requesting revision to applications for issuance of registration number, the applicants must revise precisely as specified in the documents and submit to Ministry of Health;
In case of unsatisfactory revision, Ministry of Health shall inform the applicants to revise the applications further as specified in Clause 4 of this Article;
If the applicants fail to adequately revise the applications after 90 days from the date on which Ministry of Health issues requesting documents or if the applicants fail to adequately revise the applications 5 consecutive times, the applicants must follow procedures for issuance of registration number again;
During revision process, if documents specified in Points c, d and e Clause 1 Article 26 expire, the applicants must submit valid replacements. These replacements must satisfy requirements under Article 28 of this Decree.
6. In case appraisal councils request revision of applications, within 10 working days from the date on which meeting minutes of the councils are produced, Ministry of Health shall inform the applicants in writing to revise the applications. The written notice must specify all documents and details that need to be revised.
After receiving documents requesting revision to applications for circulation, the applicants must revise precisely as specified in the documents and submit to Ministry of Health. Submission dates of revised applications shall be specified on the receipt notice.
In case of unsatisfactory revision, Ministry of Health shall inform the applicants to revise the applications further as specified in Clauses 4 and 5 of this Article.
7. Within 3 working days from the date on which registration number is issued, Ministry of Health is responsible for publicizing following information on their website:
a) Name, classification, manufacturing facilities and manufacturing countries of medical devices;
b) Registration number of medical devices;
c) Name and address of owners of medical devices;
d) Name and address of holders of registration number;
dd) Name and address of facilities providing warranty services for medical devices;
e) Application for circulation of medical devices, except for information specified in Point h Clause 1 Article 26 of this Decree.
8. During circulation of medical devices, holders of registration number are responsible for informing Ministry of Health in writing within 10 working days from the date on which any of following changes occur:
a) Changes to address of owners of medical devices or holders of registration number of medical devices; or
b) Changes to name of holders of registration number. Holders of registration number are responsible for sending notice together with documents proving medical device ownership of new holders and label samples as specified in Article 54 of this Decree;
c) 29Changes to either name or address of manufacturing facilities of medical devices. Holders of registration number are responsible for attaching following documents to notice on changes: certificates of free sale and certificates of conformance with quality control standards that are valid at the time of submission;
d) 30Changes to packing methods of in vitro diagnostic medical devices. Holders of registration number are responsible for attaching documents corresponding to the changes to notice on changes;
dd) Changes to facilities providing warranty services. Holders of registration number are responsible for attaching documents specified in Point dd Clause 1 Article 26 of this Decree to notice on changes;
e)31 Changes to labels and/or use instructions without any changes to designation: Holders of registration number are responsible for attaching documents corresponding to the changes to notice on changes.
9. Within 3 working days from the date on which written notice of holders of registration number is received, Ministry of Health is responsible for updating information in documents for management of medical devices and on their website.
10. Minister of Health shall prescribe appraisal of applications for issuance of registration number specified in Clause 3 of this Article.
Section 4. AFTER-SALE MANAGEMENT OF MEDICAL DEVICES AND DISPOSAL OF MEDICAL DEVICES IN SPECIFIC CASES
Article 30. Requirements for documents for after-sale management of medical devices32
Holders of registration number must establish, organize and manage traceability of medical devices on the market and fully store documents for management of medical devices. Following documents are mandatory:
1. Applications for circulation of medical devices, in which following documents must be stored in physical form:
a) Power of attorney of owners of medical devices for organizations applying for circulation, except for cases specified in Point a Clause 1 Article 21 of this Decree;
b) Certificate of warranty capability issued by owners of medical devices, except for disposable medical devices prescribed by owners thereof or cases in which warranty services are not required;
c) Certificates of free sale.
2. Distribution documents (holders of registration number that are representative offices are not required to store but must request facilities that the holders have authorized for import to store the documents).
3. Logs of adverse events, complaints and remedial measures therefore which specify names, types, quantities and batch numbers of the medical devices involved, especially those that are defective or unsafe for users.
4. Medical device quality control documents include:
a) Certificate of origin pursuant to Decree No. 31/2018/ND-CP dated March 08, 2018 of Government on elaborating to Law on Foreign Trade Management regarding Goods Origins;
b) Certificates of quality of each batch issued by owners or manufacturers of medical devices that are named in the application for circulation of medical devices;
c) Inspection results of medical devices for devices specified in Clause 1 Article 49 of this Decree.
Article 31. Handling of medical devices that pose serious threats to public health or possibly lead to deaths of users33
1. In case Vietnamese or international competent agencies issue warnings against medical devices regarding possible threats to public health or deaths of users, holders of registration number of the medical devices must inform health facilities that are utilizing the medical devices about the warned threats, conduct investigations and verify within 30 days from the date on which the warnings are received. In case investigations and verification take longer than 30 days, inform Ministry of Health in writing to specify reasons and propose solutions to guarantee safety of users.
2. In case medical devices under Clause 1 of this Article is identified to be defective medical devices that harm users' health, holders of registration number are responsible for:
a) suspending circulation of the medical devices;
b) informing Ministry of Health and organizations and individuals distributing and using the medical devices in writing. The notice must specify manufacture batch, defects that pose harm to health of users and whether or not the defects can be rectified;
c) preparing plans to rectify or recall batches of defective medical devices;
d) reporting to Ministry of Health after completing rectification or recall of medical devices.
3. In case defects of medical devices which harm health of users can be rectified:
a) Within 3 working days from the date on which notice of holders of registration number of the medical devices is received, Ministry of Health are responsible for suspending circulation of medical device batches;
Decisions on suspension consist of:
- Name of suspended medical devices;
- Batch number of suspended medical devices;
- Registration number of suspended medical devices.
b) After decisions on suspension of medical device batches are issued, holders of registration number are responsible for rectifying the defects that harm health of users;
c) After rectifying the defects that harm health of users, holders of registration number are responsible for submitting reports to Ministry of Health together with verification results in case of medical devices specified in Clause 1 Article 49 of this Decree or commitment regarding quality assurance of medical devices after rectifying defects in the reports in case of other medical devices;
d) Within 20 days after receiving reports on rectification of defects that harm health of users of medical device batches submitted by holders of registration number, Ministry of Health are responsible for issuing decisions on terminating suspension of circulation of medical device batches. In case Ministry of Health decides not to terminate suspension, provide written response and explanation for rejection.
4. In case defects of medical devices which harm health of users cannot be rectified:
a) Ministry of Health is responsible for issuing decisions on recall of all defective medical device batches.
Decisions on recall consist of:
- Name of recalled medical devices;
- Batch number of recalled medical devices;
- Registration number of recalled medical devices.
b) Holders of registration number are responsible for recalling the entire batch of defective medical devices before time limit decided by competent authorities and incur all expenses on recall of batches of defective medical devices.
c) In case holders of registration number fail to recall batches of defective medical devices within the time limit according to decisions of competent authorities, the recall shall be enforced according to regulations and law on administrative penalties.
Article 32. Handling of cases in which medical devices have caused adverse events affecting health of users34
1. In case medical devices that have caused serious threats to public health or deaths of users, holders of registration number are responsible for:
a) informing on website of the holders (if any) and sending notice on the adverse events to facilities that trade or utilize the batches medical devices and to Ministry of Health;
b) suspending circulation of medical devices involved in the adverse events;
c) conducting investigations and verification to determine the case;
d) reporting to Ministry of Health after receiving investigation and verification results. In case the accidents are identified to be caused by defects of medical devices, specify the defects and whether or not rectification of the defects is possible. Rectify or recall batches of defective medical devices and report to Ministry of Health after completing rectification or recall.
2. In case medical devices that do not cause deaths of users but pose serious threats to public health, holders of registration number are responsible for:
a) informing Ministry of Health about the accidents;
b) conducting investigations and verification to determine the case;
c) reporting to Ministry of Health after receiving investigation and verification results. In case the accidents are identified to be caused by defects of medical devices, specify the defects and whether or not rectification of the defects is possible. Rectify or recall batches of defective medical devices and report to Ministry of Health after completing rectification or recall.
3. Disposal of defective medical devices that affect health of users shall comply with Clauses 3 and 4 Article 31 of this Decree.
Article 33. Handling, rectification and recall of defective medical devices35
1. Methods of handling medical devices include:
a) Providing instructions on how to fix the defects;
b) Rectifying the defects of medical devices;
c) Replacing defective medical devices by equivalent medical devices;
d) Recalling for re-export or disposal.
2. Defective medical devices shall be recalled in following methods:
a) Voluntary recall implemented by holders of registration number;
b) Compulsory recall for cases specified under Article 35 of this Decree.
Article 34. Disposal of medical devices whose owners or holders of registration number no longer manufacture, go bankrupt or dissolve
1. Medical devices issued with registration number whose owners declare to no longer manufacture, go bankrupt or dissolve may continue to be circulated for no more than 24 months from the date on which owners of the medical devices declare to cease manufacture, bankrupt or dissolve if the owners issued commitment on warranty, maintenance or provision of materials for replacement or use of medical devices for 8 years, except for cases in which holders of registration number are standing representative offices in Vietnam of foreign traders who own the medical devices.
2. Medical devices issued with registration number whose owners go bankrupt or dissolve may continue to be circulated for no more than 24 months from the date on which owners of the medical devices declare bankrupt or dissolve if distributing facilities issued commitment on warranty, maintenance or provision of materials for replacement or use of medical devices for up to 8 years.
3. Holders of registration number or distributing facilities are responsible for submitting the commitment to Ministry of Health within 60 days from the date on which owners of medical devices or holders of registration number declare to cease manufacture, go bankrupt or dissolve.
4. The commitment consists of following documents:
a) Written commitments regarding responsibilities for warranty, maintenance and provision of materials for use of medical devices using forms under Annex XI attached to this Decree;
b) List of medical devices issued with registration number, stored in facilities and owned by owners or holders of registration number who declare to no longer manufacture, go bankrupt or dissolve.
5. Within 15 working days from the date on which commitments specified in Clause 4 of this Article are received, Ministry of Health is responsible for responding in writing regarding permission for circulation of medical devices. In case of rejection, specify reasons.
6. In case circulation of medical devices specified in Clause 1 of this Article are not allowed to be circulated by Ministry of Health, holders of registration number or distributing facilities are responsible for recalling the medical devices that are in circulation, except for those that have been sold to users.
Section 5. RECALL OF REGISTRATION NUMBER OF MEDICAL DEVICES
Article 35. Cases of recall of registration number
1. Applicants for circulation fabricate their applications.
2. 36 3 batches of a medical device are recalled during effective period of registration number, except for cases of voluntary recall performed by holders of registration number.
3. Applicants for circulation falsify or alter contents of registration number.
4. Holders of registration number terminate operation or are no longer authorized by owners of medical devices without replacements, except for cases specified in Article 34 of this Decree.
5. Circulated medical devices are not satisfactory to registered quality.
6. Registration number issued ultra vires, against documents or procedures specified in this Decree.
7. Medical devices whose holders of registration number or distributing facilities that do not commit as specified in Clauses 1 and 2 Article 34 of this Decree.
8. Circulation period of medical devices is expired as specified in Clauses 1 and 2 Article 34 of this Decree.
9. Medical devices are manufactured by facilities unsatisfactory to this Decree.
10.37 Holders of registration number fail to comply with Point i Clause 2 Article 66 of this Decree, except for cases specified in Article 34 of this Decree
11. 38 Documents on declaration of holders of registration number do not comply with Articles 22 and 23 of this Decree or use fabricated documents therein.
12. 39 Medical devices are concluded by Ministry of Health to be incorrectly classified according to regulations on classification of medical devices.
Article 36. Procedures for recall of registration number
1. If any of the cases specified in Clauses 1, 2, 3, 4, 5, 6, 8 and 9 Article 35 of this Decree is discovered via inspection or examination, inspecting or examining agencies must produce records and submit to Ministry of Health or Health Departments that have issued the registration number (hereinafter referred to as “registration number issuing bodies”).
2. Within 5 working days from the date on which the records specified in Clause 1 of this Article are received, registration number issuing bodies shall consider and decide on recall of registration number under their management.
3. After issuing decisions on recall of registration number, agencies issuing decisions on recall are responsible for:
a) 40 uploading the decisions on recall of registration number on website of registration number issuing bodies and submitting the decisions to holders of registration number, Ministry of Health, Health Departments of provinces and central-affiliated cities and customs authorities;
b) removing information related to medical devices that is uploaded on website of registration number issuing bodies.
3. After receiving decisions on recall of registration number of registration number issuing bodies, Health Departments are responsible for uploading decisions on recall of registration number in full on their website and directing specialized agencies to supervise recall of medical devices.
Chapter V
MANAGEMENT OF MEDICAL DEVICE TRADING
Section 1. ELIGIBILITY FOR MEDICAL DEVICE TRADING
Article 37. Eligibility for trading Type B, C and D medical devices41
1. Have at least 01 employee who has at least a college degree in technology, health, pharmacy or medical devices or at least a college degree suitable for the medical devices sold by the establishment;
2. Have at least a warehouse and a vehicle that satisfy the following basic requirements:
a) Warehouses must:
- have an area suitable for the categories and quantities of medical devices stored therein;
- be airy, dry and clean, separated from sources of pollution;
- satisfy storage conditions of the medical devices according to their instructions manuals.
b) Vehicles for delivery of medical devices are suitable for the devices delivered;
An establishment without a warehouse or vehicle must sign a contract with a competent storage and transport service provider.
3. In case of facilities trading medical devices containing narcotics and precursors:
a) Specialized individuals bachelor’s degree in medical devices, health, pharmacy, chemistry or biology;
b) Have storage satisfactory to Article 7 of Decree No. 80/2001/ND-CP;
c) Have an inventory monitoring system for medical devices containing narcotics and precursors.
Article 38. Documents and procedures for declaring eligibility for manufacturing medical devices42
1. Applications for declaration of eligibility for trading medical devices consist of:
a) Declaration of eligibility for trading medical devices using Form No. 07 under Annex I attached to this Decree;
b) Declaration of personnel using forms under Annex II attached to this Decree;
c) Documents proving satisfaction of storage and transports of medical devices to requirements under Clause 2 Article 37 of this Decree. Documents must be confirmed by applicants for eligibility for trading;
d) Documents satisfaction of storage and inventory managing systems for medical devices containing narcotics and precursors to requirements under Clause 3 Article 37 of this Decree. These documents must be confirmed by applicants for eligibility for trading of medical devices containing narcotics and precursors.
2. Procedures for declaration of eligibility for trading:
a) Prior to trading of Type B, C or D medical devices, heads of trading establishments are responsible for submitting applications for declaration of eligibility for trading as specified in Clause 1 of this Article to Health Departments where the facilities are based;
b) Upon receiving the applications, Health Departments shall issue notice on receipt of applications for declaration of eligibility for manufacturing using Form No. 05 under Annex IV attached to this Decree;
c) Within 3 working days from the date on which applications for declaration of eligibility for trading are received, Health Departments are responsible for publicizing following information on their website: name and address of medical device trading establishments; applications for declaration of eligibility for trading medical devices.
3. An establishment shall only trade Type B, C and D medical devices after completing procedures for declaration of eligibility for trading specified Clause 2 of this Article, except for cases specified in Article 39 of this Decree.
4. Revision of contents of declarations of eligibility for trading medical devices:
a) Cases in which revision of contents of declarations of eligibility for trading medical devices is permitted:
- Change of technicians of trading establishments;
- Change of address and/or phone number.
b) Applications for revision of contents of declarations of eligibility for trading medical devices:
- Written request for revision shall be prepared using Form No. 21 under Annex I attached to this Decree, which specifies the changes;
- In case of change of technicians: Declaration of personnel using forms under Annex II attached to this Decree, which specifies the change;
- In case of change of address and/or phone number: Documents proving changes to address and/or phone number of trading establishments.
c) Procedures for revision:
- Upon receiving applications for revision of contents of declarations of eligibility for trading medical devices, Health Departments shall issue notice on receipt of applications for revision of declaration of eligibility for trading medical devices using Form No. 15 under Annex IV attached to this Decree;
- Within 3 working days from the date specified on the receipt notice, Health Departments are responsible for updating changes on the website. In case of rejection, produce written response and explanation.
5. During operation process, trading establishments must follow procedures for declaring eligibility for trading again if any changes related to previous declarations that are not specified in Point a Clause 4 of this Article occur.
Article 39. Trading of medical devices without satisfying eligibility and following procedures for declaring eligibility for trading
1. Type B, C and D medical devices under list of medical devices issued by Minister of Health shall be traded as regular goods.
2. Trading of medical devices specified in Clause 1 of this Article does not require satisfaction of eligibility under Article 37 of this Decree and completion of procedures for declaring eligibility for trading under Article 38 of this Decree but must satisfy requirements for preservation, storage and transportation prescribed by owners of medical devices.
Section 2. EXPORT AND IMPORT OF MEDICAL DEVICES
Article 40. Principles of managing import and export of medical devices
1. Organizations and individuals importing and exporting medical devices must satisfy requirements according to import and export laws and must be responsible for guaranteeing quality of medical devices that they import and/or export.
2. 43 Medical devices issued with registration number in Vietnam shall be permitted for import and export on demand regardless of quantity without being approved by Ministry of Health, except for medical devices containing narcotics and precursors.
3. Issuance of certificates of free sale only applies to medical devices exported under regulations of Prime Minister.
4. Temporary import for re-export, temporary export for re-import or transit of medical device shall comply with regulations and law.
5. Import of second-hand medical devices shall comply with commercial laws.
Article 41. Export and import of medical devices
1. Encourage domestic enterprises manufacture for export.
2. 44 Organizations and individuals importing medical devices issued with registration number must satisfy following requirements:
a) Be holders of registration number or hold power of attorney of holders of registration number. When a holder of registration number authorizes an importing facility to import medical devices, he/she must also submit the power of attorney to registration number issuing body and customs authority;
b) Have storage and transports satisfactory to Clause 2 Article 37 of this Decree or sign contracts with competent facilities capable of preserving and transporting medical devices;
c) Have storage and inventory managing systems for medical devices containing narcotics and precursors satisfactory to requirements under Clause 3 Article 37 of this Decree.
3. Procedures for import and export of medical devices shall comply with regulations of law on customs. Organizations importing medical devices are not required to prove satisfaction to requirements specified in Clause 2 of this Article when following customs procedures.
Article 42. Import and export permits45
1. Cases in which import permits are required:
a) Unregistered medical devices imported to serve scientific research, inspection or training in use or repair of medical devices;
b) Unregistered medical devices imported to serve assistance or humanitarian aid;
c) Unregistered medical devices imported to serve humanitarian medical examination and treatment;
d) Unregistered medical devices imported to personal treatment including medical devices specifically manufactured under prescription for personal treatment or under particular diagnosis requirements of health facilities;
dd) Registered medical devices containing narcotics and precursors, materials for manufacturing medical devices that are narcotics and precursors;
e) Medical devices containing narcotics and precursors imported to serve scientific research or inspection;
g) Used medical devices imported to serve research and training (no use on humans, no use for diagnostic or treatment purposes). Import of medical devices in this case shall comply with regulations of Prime Minister;
h) Materials for manufacturing medical devices that are narcotics and precursors imported to serve scientific research or inspection.
2. Cases in which export permits are required:
a) Medical devices containing narcotics and precursors:
b) Materials for manufacturing medical devices that are narcotics and precursors.
3. Applications for issuance of import permit consist of:
a) Application for issuance of import permit prepared using form No. 08 under Annex I attached to this Decree;
b) Documents containing brief technical description of the medical devices in Vietnamese using Form No. 1 under Annex VIII attached to this Decree;
c) Certificate of conformity with quality control standards of manufacturing facilities confirmed by applicants;
d) In case of import for research, certified true copies of decisions on approval of research and documents proving permission for circulation of medical devices to be imported granted by competent agencies and bearing certification of applicants;
dd) In case of import for training, original copies of training programs and documents proving permission for circulation of medical devices to be imported granted by competent agencies and bearing certification of applicants;
e) In case of import for inspection: Certification of certifying bodies which specifies quantity of devices;
g) In case of import for assistance, copies of decisions on approval of assistance and documents proving permission for circulation of medical devices to be imported granted by competent agencies and bearing certification of applicants;
h) In case of import for humanitarian medical examination and treatment, original copies of training programs and documents proving permission for circulation of medical devices to be imported granted by competent agencies and bearing certification of applicants;
i) In case of import for particular diagnostic purposes of health facilities, documents proving permission for circulation of medical devices to be imported granted by competent agencies and bearing certification of applicants;
k) In case of import for personal medical treatment, copies of doctor prescription consistent with illnesses of applicants.
4. Applications for import of medical devices containing narcotics and precursors:
a) Applications for import of registered medical devices containing narcotics and precursors:
- Form No. 13 under Annex I attached to this Decree which specifies reason for quantity of medical devices containing narcotics and precursors to be imported exceeding the previous imported quantity by 150%;
- Sales report of medical devices containing narcotics and precursors using Form No. 02 under Annex X attached to this Decree;
b) Applications for import of medical devices containing narcotics and precursors imported to serve scientific research or inspection;
- Written application for import shall be prepared using form No. 13 under Annex I attached to this Decree;
- Documents specified in Points b, c, d and e Clause 3 Article 42 of this Decree.
5. Applications for import of manufacturing materials of medical devices containing narcotics and precursors:
a) Written application for import shall be prepared using form No. 14 under Annex I attached to this Decree;
b) Copies of applicable standards and methods of inspecting contents of narcotics and precursors of manufacturing facilities bearing stamps of importing facilities.
c) Certified true copies of manufacturing permits of material manufacturing facilities issued by competent agencies of exporting countries. Manufacturing permits must be consular legalized according to regulations and law on consular legalization, except for cases of exemption as per the law;
If documents under Points b and c of this Clause are not in Vietnamese or English, submit authenticated Vietnamese or English translations of the documents.
d) Reports on use of manufacturing materials of medical devices containing narcotics and precursors using Form No. 3 under Annex X attached to Decree;
dd) Sales report of manufacturing materials of medical devices containing narcotics and precursors using Form No. 02 under Annex X attached to this Decree;
e) Manufacturing and use schemes for materials requested for import and estimated business plans for products created by materials requested for import.
6. Applications for import of manufacturing materials of medical devices containing narcotics and precursors for inspection and research:
a) Written applications for import of manufacturing materials of medical devices containing narcotics and precursors using Form No. 14 under Annex I attached to this Decree;
b) In case of import for research for manufacture of medical devices, certification of the applicants proving use of manufacturing materials of medical devices containing narcotics and precursors in research;
c) In case of import for inspection, certification of certifying bodies which specifies quantity of devices;
7. Applications for export of medical devices containing narcotics and precursors, materials for manufacturing medical devices containing narcotics and precursors:
a) Written application for import prepared using Form No. 15 or 16 under Annex I attached to this Decree;
b) Reports on quantity and origins of medical devices and manufacturing materials of medical devices containing narcotics and precursors using Form No. 4 under Annex X attached to Decree;
c) Valid documents permitting import of medical devices and manufacturing materials of medical devices containing narcotics and precursors issued by competent managing bodies of importing countries. Documents permitting import that are not in English or Vietnamese must be attached to by authenticated Vietnamese or English translation thereof. Documents permitting import must be consular legalized according to regulations and law on consular legalization, except for cases of exemption as per the law.
8. Procedures for considering applications for permission of import and export of medical devices and manufacturing materials of medical devices containing narcotics and precursors:
a) After receiving applications for permission for import and export of medical devices and manufacturing materials of medical devices containing narcotics and precursors, Ministry of Health shall send notice on receipt of application using Form No. 6 under Annex IV attached to this Decree to the applicants;
b) In case revisions to the applications are not required, Ministry of Health shall appraise to permit import and export within 15 working days from the date specified on the receipt notice. In case of rejection, provide written response and explanation. In case of granting permission for export of medical devices containing narcotics or precursors and materials containing narcotics and precursors, Ministry of Health must appraise to permit export within 15 working days from the date on which Ministry of Public Security issues pre-export notifications. In case of rejection, provide written response and explanation;
Import and export permits shall be sent to the applicants and customs authorities. In case of medical devices containing narcotics or precursors, the permits shall also be submitted to Ministry of Public Security and Ministry of Finance;
Permits for import and export of medical devices containing narcotics and precursors, manufacturing materials of medical devices that are narcotics and precursors shall be issued for each instance of import and export and effective for the duration specified in the permits.
c) In case of unsatisfactory applications, Ministry of Health must inform the applicants in writing for revision within 5 working days from the date specified on the receipt notice. The written notice must specify all documents and details that need to be revised.
d) After receiving documents requesting revision to the applications, the applicants must revise precisely as specified in the documents and submit to Ministry of Health;
In case of unsatisfactory revision of the applications, Ministry of Health shall inform the applicants for further revision.
dd) If the applicants fail to adequately revise the applications after 60 days from the date on which Ministry of Health issues written request, they shall follow the procedures again.
e) If no further revisions are required, Ministry of Health is responsible for granting import and export permission as specified in Point b of this Clause. Import and export permits shall be sent to the applicants and customs authorities.
Article 43. Applications for issuance of certificates of free sale for domestically manufactured medical devices46
Ministry of Health shall only issue certificates of free sale for medical devices already issued with registration number.
1. Applications for issuance of certificates of free sale for medical devices:
a) Application for certificates of free sale prepared using form No. 12 under Annex I attached to this Decree;
b) Certified true copies of certificate of conformity with quality and standards accredited by conformity assessment bodies as per the law that are valid at the time of submission;
c) Valid master registers or copies of registration number;
2. Procedures for issuance of certificates of free sale shall comply with Decree No. 69/2018/ND-CP dated May 15, 2018 of Government on elaborating to Law on Foreign Trade Management.
3. Certificates of free sale shall be prepared using form No. 12 under Annex IV attached to this Decree.
Article 44. Entitlement and procedures for new issuance, reissuance and revocation of certificates of free sale
1. Minister of Health is responsible for issuing new, issuing another and revoking certificates of free sale of medical devices.
2. Procedures for new issuance, reissuance and revocation of certificates of free sale shall comply with regulations of Prime Minister on issuance of certificates of free sale.
Section 3. RIGHTS AND OBLIGATIONS OF ORGANIZATIONS AND INDIVIDUALS PARTICIPATING IN MEDICAL DEVICE TRADING
Article 45. Rights of medical device trading facilities
1. Requesting medical device sellers to fully provide information and traceability and warranty documents of medical devices.
2. Requesting organizations and individuals that import, distribute and use products to cooperate in recalling and disposing defective medical devices.
3. Requesting holders of registration number to exercise medical device warranty obligations.
4. Being informed about defective medical devices by holders of registration number.
5. Other rights as per the law.
Article 46. Obligations of medical device trading facilities
1. Adopting internal control measures to maintain quality of medical devices as prescribed my holders of registration number.
2. Fully and promptly providing users with information about:
a) Use instruction of medical devices; safety, preservation, calibration, inspection and maintenance conditions of medical devices;
b) Notice on defective medical devices.
3. Maintaining medical device monitoring dossiers, implementing traceability and recalling medical devices as specified in this Decree.
4. Promptly informing holders of registration number and regulatory agencies about defective medical devices.
5. Complying with regulations and law and decisions on inspection of competent authorities.
6. Other obligations as per the law.
Chapter VI
MEDICAL DEVICE-RELATED SERVICES
Section 1. MEDICAL DEVICE TECHNICAL CONSULTANCY
Article 47. Eligibility for providing medical device technical consultancy services
1. Provision of consultancy services regarding preparing lists and developing configuration and technical functions of medical devices must be performed by individuals issued with certificates of medical device technical consultancy training.
2. Eligibility of individuals providing medical device technical consultancy:
a) Have university education level or higher in technical, medical or pharmaceutical major;
b) Have experience in operating in technical of medical devices in medical device facilities for least 05 years;
c) Be trained and recognized for eligibility for providing medical device technical consultancy after following training programs issued by Ministry of Health.
3. Individuals shall only provide medical device technical consultancy after having been issued with notice on receipt of declarations of eligibility for providing medical device technical consultancy as specified in Point b Clause 2 Article 48 of this Decree.
Article 48. Documents and procedures for declaring eligibility for providing medical device technical consultancy
1. Applications for declaration of eligibility for providing medical device technical consultancy consist of:
a) Written applications for declaration of eligibility for medical device technical consultancy using Form No. 09 under Annex I attached to this Decree;
b) Certified true copies of degrees and certificates specified in Points a and c Clause 2 Article 47 of this Decree;
c) Working period confirmation using form under Annex III attached to this Decree.
2. Procedures for declaration of eligibility for providing medical device technical consultancy:
a) Applicants for declaration of eligibility for providing medical device technical consultancy are responsible for submitting the applications specified in Clause 1 of this Article to Ministry of Health;
b) Upon receiving satisfactory applications, Ministry of Health issue notice on receipt of application using Form No. 07 under Annex IV attached to this Decree;
c) Within 3 working days from the date written on the receipt notice, Ministry of Health is responsible for publicizing following information on their website: name, address and phone number of consultants; scope of medical device technical consultancy and declarations of eligibility for medical device technical consultancy.
3. During operation process, consultants must follow procedures for declaring eligibility for providing consultancy if any change related to previously issued declarations occur.
Section 2. INSPECTION AND CALIBRATION OF MEDICAL DEVICES47
Article 49. Principles of inspection and calibration of medical devices
1. Medical under lists publicized by Minister of Health must undergo safety and technical inspection before being brought into operation (except for cases specified under Article 51 of this Decree), on a periodic basis or after major repair. Inspection of medical devices that are measuring instruments and radiating devices shall comply with Clause 2 of this Article.
2. Medical devices that measures and/or radiates must undergo inspection and calibration according to regulations and law on metrology and atomic energy.
Article 50. Eligibility for provision of medical device inspection services
Facility and personnel requirements; applications for issuance of certificates; methods of submission; procedures for new issuance, supplementary issuance and revocation of certificates of registration of medical device inspection shall comply with applicable regulations and law on provision of conformity assessment services;
In which, satisfaction to specialized requirements in medical device inspection shall be prescribed as follows: each inspection process must be carried out by at least 2 accrediting individual of an accreditation organization who have been trained in the inspection process.
Article 51. Exemption of first-time inspection of medical devices before being brought into operation
Following medical devices shall be exempted from first-time inspection when brought into operation:
1. Medical devices issued with certificates of conformity;
2. Unregistered medical devices imported to serve scientific research, to train medical device use, maintenance or repair;
3. Unregistered medical devices imported for personal treatment of importers, humanitarian medical examination and treatment or special diagnostic requirements;
4. Unregistered medical devices imported to serve carnivals, exhibits, display and product launch events.
Article 52. Disposal of medical devices unsatisfactory to inspection requirements
1. In case medical devices with unsatisfactory inspection results are about to be brought into operation:
a) Health facilities must not receipt or use the medical devices;
b) Accreditation organizations shall submit unsatisfactory inspection results to Ministry of Health;
c) In case safety and functionality inspection results of 3 medical devices in the same batch are unsatisfactory, Ministry of Health shall request of holders of registration number in writing to report quantity of medical devices currently in circulation and in use at health facilities;
Based on reports of holders and unsatisfactory inspection results, Ministry of Health shall decide on reinspection, number of specimen subject to reinspection or suspension of medical devices;
Based on reinspection results, Ministry of Health shall decide on reinspection, additional number of specimen subject to reinspection or requesting holders of registration number to recall of all medical devices in that batch;
In case 3 batches of medical devices are recalled during effective period of registration number, revoke registration number for the medical devices. Medical devices being use in health facilities prior to issuance of decisions on revocation of registration number shall be used if inspection results thereof are satisfactory.
2. In case periodic inspection results of medical devices after major repair are unsatisfactory:
a) Health facilities must not continue to use the medical devices;
b) Remove previous inspection status;
c) Cooperate with holders of registration number in adopting rectifying measures and conduct reinspection.
d) Only use the device upon satisfactory inspection results.
Chapter VII
INFORMATION AND LABELS OF MEDICAL DEVICES
Article 53. Information about medical devices
1. Information about medical devices must provide health officials and users of medical devices with proper and safe use instruction.
2. Information about medical devices must be complete, objective, accurate, honest, comprehensible and not causing misunderstanding.
3. Responsibilities for medical device information shall be prescribed as follows:
a) Holders of registration number and medical device trading facilities are responsible for publicizing information about risk level and information related to use of medical devices;
b) Health facilities are responsible for popularizing information about medical devices within the facilities;
c) Health officials and employees are responsible for providing patients with information about risk levels of Type C and D medical devices;
d) Medical device managing agencies are responsible for providing information about medical devices.
4. Organizations and individuals providing information about medical devices must be responsible for information that they provide.
5. Minister of Health is responsible for organizing medical device information systems.
Article 54. Labels of medical devices
1. 48 Labeling of medical devices shall comply with applicable product labeling laws.
2. In case labels of medical devices imported to Vietnam fail to adequately display information specified in Clause 1 of this Article, additional labels displaying basic information in Vietnamese are required while original labels are retained.
Chapter VIII
MANAGEMENT AND USE OF MEDICAL DEVICES IN HEALTH FACILITIES
Article 55. Principles of managing and using medical devices
1. Management and use of medical devices must be for correct purposes, functions, regimens and must be efficient and effective.
2. 49 Medical devices must be preserved, maintained, used, satisfactory to other technical guidelines according to manufacturers and subject to inspection specified in this Decree to ensure adequate quality.
Medical devices subject to strict regulations on occupational safety and hygiene must comply with regulations and law on occupational safety and hygiene in addition to regulations under this Decree.
3. Adequately prepare, manage and store documents related to medical devices; promptly and adequately do medical device accounting regarding tangible assets and value according to applicable regulations and law on accounting, inventory and other relevant law provisions; ensure expenditure on execution of tasks specified in Clause 2 of this Article.
4. Be subject to inspection and supervision of competent managing agencies regarding management of medical devices.
Article 56. Management and use of medical devices in state health facilities50
In addition to management and use of medical devices as specified in Article 55 of this decree, state health facilities must perform medical device management in accordance with following regulations:
1. Investment, procurement, management and use of medical devices must comply with regulations and law on management and use of public assets.
2. Encourage use of domestically manufactured medical devices.
Article 57. Rights and responsibilities of health facilities in managing and using medical devices
1. Heath facilities shall have following rights:
a) to request holders of registration number to carry periodic maintenance within warranty period;
b) to request sellers to provide technical documents of medical devices;
c) to receive second-hand medical devices to serve scientific research and provide instructions on use and repair of medical devices.
2. Heath facilities are responsible for:
a) using and operating medical devices as instructed by owners of medical devices;
b) periodically maintaining, inspecting and calibrating as instructed by owners of medical devices or prescribed by regulations and law;
c) participating in tests and quality evaluation of medical devices;
d) reporting on defective medical devices and other information requested by competent authorities;
dd)51 health facilities must examine quality control documents upon receiving medical devices; store and update experimental results of medical gases.
Chapter IX
ONLINE DECLARATION AND REGISTRATION
Article 58. Cases of online declaration, registration and applications for permission
1. Declaration of eligibility for practicing medical device classification.
2. Declaration of eligibility for manufacturing medical devices.
3. Declaration of applicable standards of medical devices.
4. Registration for circulation of medical devices.
5. Declaration of eligibility for trading medical devices.
6. Declaration of eligibility for providing medical device technical consultancy.
7. 52Application for issuance of certificates of registration of medical device inspection.
8. Application for issuance of import permit of medical devices.
9. Applications for issuance of certificates of free sale for domestically manufactured medical devices.
10. 53 Issuance of practising certificates.
Article 59. Requirements for online declaration, registration and applications for permission
Online applications for declaration, registration, permission and issuance of certificates of free sale (hereinafter referred to as “applications”) shall be eligible when following requirements are met:
1. Adequate documents with sufficient contents similar to physical documents converted to electronic form. Name of electronic documents must be consistent with name of physical version thereof.
2. Information that is declared, registered or applied for permission must be provided adequately and accurately according to information in electronic documents.
Article 60. Procedures for online declaration
1. Legal representatives shall declare information, download electronic documents, authenticate by public digital signatures and fulfill online fees by following procedures on websites of Ministry of Health or Health Departments.
2. After submitting online applications, the legal representatives shall be issued with notice on receipt of online applications.
3. Receiving agencies shall adopt administrative procedures specified in this Decree depending on the applications.
4. Results of online administrative procedures are electronic documents bearing digital signatures of receiving agencies and shall have legitimacy similar to results of administrative procedures adopted in traditional fashion.
5. 54 During operation process, holders of registration number may retain notice on receipt of applications that is previously issued in case of changes specified in Clause 4 Article 24 of this Decree.
Article 61. Storage of online applications
1. 55 In case of online applications, applicants must store the applications as specified in Clause 1 Article 30 of this Decree.
2. In case contents of applications specified in Clause 1 of this Article are missing or damaged, applicants are responsible for informing receiving agencies in writing, revising the applications, informing the receiving agencies in writing after completing the revision and updating the applications after receiving consensus of the receiving agencies.
3. Within 35 days from the date on which receiving agencies receive notice on missing applications if the applicants do not issue notice on completion of revision, receiving agencies are responsible for:
a) removing information uploaded on website related to classifying facilities, manufacturing facilities, trading facilities, technical consultant, accreditation organizations, calibration organizations and registration number of medical devices;
b) revoking registration number and medical device import permit.
4. Applicants must not proceed with operation and medical devices must not be circulated from the date on which receiving agencies remove information specified in Clause 3 of this Article.
Chapter X
IMPLEMENTATION
Article 62. Responsibilities of Ministry of Health
Ministry of Health shall be responsible to the Government for performing state management regarding medical devices and shall have following tasks and powers:
1. Presenting the Government and Prime Minister to issue or using within their competence legislative document, national technical regulations, strategies, policies and plans regarding medical devices, including:
2. Directing and organizing implementation of legislative documents, strategies, policies and plans regarding medical devices.
3. Organizing information and communication regarding medical devices.
4. Organizing training and improvement of personnel whose operations involve medical devices.
5. Publicly uploading following information on website of Ministry of Health:
a) Final bid price for procurement of medical devices of state health facilities on a nationwide scale;
b) List of medical devices whose registration number is revoked.
6. Conducting inspection, handling complaints, accusations and taking actions against violations in medical device-related affairs.
7. Performing international cooperation’s in medical devices.
8. 56 Elaborating on classification of medical devices satisfactory to international agreements on classification of medical devices of ASEAN in which Vietnam is a signatory; issuing training programs on practising classifying medical devices.
9. 57 Issuing list of medical devices that must be inspected and inspection procedures for each type of medical device under the list.
10. 58 Specifically instructing inputting methods in ASEAN common technical documents.
Article 63. Responsibilities of Ministry of Science and Technology
1. Issuing list of medical devices that are measuring instruments requiring sample approval, inspection and calibration after entering into agreement with Ministry of Health.
2. Taking charge or cooperating with Ministry of Health in developing national standards regarding medical devices; conducting inspections regarding quality of medical devices that are measuring instruments and radiating devices.
Article 64. Responsibilities of Ministry of Finance
1. Providing guidelines on managing medical devices that are public devices in state health facilities after Ministry of Health have made statements.
2. Elaborating management and use of fees and charges related to medical devices according to regulations and law on fees and charges.
Article 65. Responsibilities of provincial People’s Committees
1. Being responsible for managing operations related to trade and use of medical devices in the provinces.
2. Organizing information and communication regarding medical devices in the provinces.
3. Organizing improvement for personnel whose operations involve medical devices in the provinces.
4. Publicly uploading following information on website of provincial People’s Committees and submitting to Ministry of Health:
a) Final bid price for procurement of medical devices of state health facilities on a provincial scale;
b) List of medical devices whose registration number is revoked in the provinces..
5. Conducting inspection, handling complaints, accusations and taking actions against violations in medical device-related affairs in the provinces.
Article 66. Responsibilities of organizations and individuals trading medical devices
1. Organizations and individuals trading medical devices must be responsible for safety and quality of medical devices that they trade.
2. 59 Holders of registration number are responsible for:
a) Declaring applicable standards or registering for circulation of medical devices as specified in this Decree;
b) Establishing and maintaining medical device warranty facilities or signing contracts with medical device warranty facilities;
c) Preparing and maintaining medical device monitoring dossiers and implementing traceability of medical devices as specified in this Decree, except for disposable medical devices prescribed by owners of the medical devices; reporting to Departments of Health and police authorities upon discovering flaws or losses of medical devices containing narcotics and precursors or manufacturing materials thereof;
d) Adequately and accurately providing information about the products on labels and documents attached to medical devices according to regulations and law on product labeling and this Decree;
dd) Promptly, adequately and accurately warning about risks potentially harming health of users and environment; preventive measures for sellers and users; providing information about requirements for transport, storage, preservation and use of medical devices;
e) Promptly suspending circulation, informing relevant parties and developing measures to deal with, rectify or recall defective medical devices as specified in this Decree. In case of disposal, disposal of medical devices must comply with regulations and law on environmental protection, relevant law provisions and incurring the entire expenditure on the disposal;
g) Complying with regulations and law and decisions on inspection of competent authorities;
h) Paying compensation as per the law in case of defective medical devices;
i) Being responsible for maintaining validity of following documents during effective period of registration number:
- Certificates of free sale in case of import medical devices;
- Power of attorney except for cases specified in Point a Clause 1 Article 21 of this Decree.
- Certificates of eligibility for warranty or documents proving no warranty required.
k) Being responsible for ensuring manufacture of medical devices during effective period of Certificate of conformity with quality control standards of manufacturing facilities;
l) Being legally responsible for be legally responsible for the legality, truthfulness and accuracy of uploaded documents when following procedures specified in this Decree;
m) Providing health facilities that purchase medical devices with 1 quality control documents specified in Clause 4 Article 30 of this Decree of the medical devices;
n) Other obligations as per the law.
3. Representative offices of holders of registration number must fully satisfy obligations specified in Clause 2 of this Article.
4. 60 Facilities trading, exporting, importing and transferring medical devices containing narcotics and precursors, materials for manufacturing medical devices containing narcotics and precursors are responsible for:
a) Reporting on trading, export, import and transfer of medical devices containing narcotics and precursors, manufacturing materials of medical devices that are narcotics and precursors using Form No. 5 and 6 under Annex X attached to this Decree and submitting to Ministry of Health and to Ministry of Public Security in case of export and import of medical devices containing narcotics and precursors, manufacturing materials of medical devices that are narcotics and precursors within 10 days from the date of trading, export, import and transfer of medical devices or manufacturing materials of medical devices containing narcotics and precursors;
b) Submitting reports on a 6-month and yearly basis on storage and use of medical devices containing narcotics and precursors, materials containing narcotics and precursors using Form No. 3 under Annex X attached to this Decree to Ministry of Health before July 15 and January 15 each year;
c) Submitting reports to Departments of Health using Form No. 7 under Annex X attached to this Decree within 48 hours after discovering any faults or losses of medical devices containing narcotics and precursors and materials that are narcotics and precursors.
5. 61 Classifying facilities:
a) During operation process, classifying facilities are responsible for satisfying all requirements under Article 7 of this Decree;
b) Be responsible for and implement rectifying measures in cases of issuance of incorrect classification results regarding risk levels of medical devices or issuance of classification results beyond entitlement as specified in this Decree;
c) Publicize classification results on website of Ministry of Health within 5 working days from the date of issuance.
6. 62 Medical device manufacturing facilities may import active ingredients with pharmacological effects to manufacture medical devices. The facilities may only use imported active ingredients to manufacture medical devices and for no other purposes, except to sell to other medical device manufacturing facilities to manufacture the products. Applications and procedures for import of active ingredients with pharmacological effects to manufacture medical devices shall comply with pharmaceutical laws.
Chapter XI
IMPLEMENTATION63
Article 67. Entry into force
1. This Decree comes into force from the day of signing.
2. Clause 10 Article 12 Decree No. 89/2006/ND-CP dated August 30, 2006 of Government on product labeling shall expire from the effective date of this Decree.
Article 68. Transition clauses
1. Medical device manufacturing facilities that operate prior to effective date hereof shall continue to manufacture as long as they declare eligibility for manufacturing before July 1, 2017. With respect to regulations on quality control systems: medical device manufacturing facilities must adopt ISO 9001 quality control systems before January 1, 2018 and ISO 13485 before January 1, 2020.
2. Trading facilities that operate before the effective date hereof may continue to operate as long as they declare eligibility for trading as specified in this Decree before January 1, 2017.
3. Organizations and individuals providing services related to medical devices that operate before effective date hereof may continue to operate as long as they declare eligibility for providing technical consultancy, declare eligibility for inspection or apply for issuance of practising certificates before July 1, 2017.
4. Medical devices manufactured in Vietnam or imported to Vietnam before effective date hereof may continue to be circulated until disposal specified in Clause 1 Article 22 of Law on management and use of state assets or until the time specified on circulation registration.
5. 64 Issuance of medical device import permit or issuance of registration number for domestically manufactured medical devices or medical devices that are in vitro diagnostic reagents shall comply with applicable regulations and law until the period specified in Clause 6 of this Article expires and shall be as follows:
a) Import permits for Type B, C and D medical devices and import permits for in vitro diagnostic reagents issued in 2018, 2019, 2020 and 2021 are effective until December 31, 2021 inclusively, customs authorities shall not control import quantity in this case, except for cases specified in Clause 1 Article 42 and Point d of this Clause.
Organizations and individuals trading medical devices are responsible for ensuring validity of documents specified in Point i Clause 2 Article 66 of this Decree during effective period of import permits. In case of not maintaining validity of aforementioned documents, organizations and individuals trading medical devices must inform Ministry of Health for revocation of issued import permits as per the law.
b) Type A medical devices issued with notice on receipt of declaration of applicable standards by Departments of Health shall be imported on demand regardless of quantity without classification records and confirmation of Ministry of Health’s medical devices during clearance procedures;
In case of medical devices not specified in the list of medical devices requiring import permit but classified as Type B, C and D medical devices by classifying facilities publicized by Ministry of Health on their website may continue to be imported until December 31, 2021 inclusively on demand regardless of quantity and confirmation of Ministry of Health’s medical devices during clearance procedures.
c) In case of medical devices that are in vitro diagnostic reagents issued with circulation registration according to Law on Pharmacy in 2005 and documents providing guidelines for this Law, the issued registration number shall be effective until the period specified on the circulation registration expires. With respect to registration number of in vitro diagnostic reagents that expires after January 1, 2019 and before December 31, 2021, the issued registration number shall be effective until December 31, 2021 inclusively;
Medical devices that are in vitro diagnostic reagents whose applications for circulation have been submitted according to Law on Pharmacy in 2005 before January 1, 2019 shall be processed according to Law on Pharmacy in 2005;
Medical devices that are imported in vitro diagnostic reagents whose applications are submitted from January 1, 2019 to December 31, 2021 inclusively shall be issued with import permits according to Law on Pharmacy in 2005 and shall be effective until December 31, 2021;
Applications for issuance and issuance of registration number of domestically manufactured medical devices shall be received from January 1, 2019. Registration number shall come into effect from date of issue.
d) In case of chemicals, pesticides and disinfectants only for sterilizing medical devices domestically and medically issued with circulation registration that expires after July 1, 2016 and before December 31, 2020, the circulation registration may be used until December 31, 2020 inclusively;
Applications for issuance and issuance of registration number of domestic and medical chemicals, pesticides and disinfectants used solely for sterilizing medical devices shall be received from January 1, 2019. Registration number shall come into effect from date of issue.
dd) In case of domestically manufactured medical devices issued with circulation registration, the registration number shall be effective until the period specified on the circulation registration. With respect to circulation registration that expires after July 1, 2016 and before December 31, 2020, the issued circulation registration shall be effective until December 31, 2020 inclusively;
6. 65 Declarations of applicable standards of Type A medical devices shall be received from January 1, 2017 and notice on receipt of declarations of applicable standards shall be effective from July 1, 2017; applications for circulation registration of Type B, C and D medical devices shall be received from July 1, 2017 and registration number of medical devices shall be effective from January 1, 2022, except for cases specified in Point c and d Clause 5 of this Article.
7. Labels of medical devices manufactured in Vietnam or imported to Vietnam before dates specified in Clause 5 of this Article may continue to be circulated until expiration date of the devices or until disposal specified in Clause 1 Article 22 of Law on management and use of state assets or until the time specified on circulation registration.
8. 66 Medical device classifying organizations are responsible for publicizing classification results of medical devices that are issued before December 31, 2018 on website of Ministry of Health before April 1, 2019
Documents proving classification results in form of recognition submitted to managing agencies before December 31, 2018 shall be used for registration for circulation of the medical devices.
9. 67 All certificates of medical device classification issued before December 31, 2018 are effective for 3 years from the day on which they are signed.
10. 68 Holders of registration number must review classification results of medical devices as specified in Clause 2 Article 4 of this Decree and report to Ministry of Health before July 1, 2019.
In case the review shows changes to risk levels, holders of registration number are responsible for adopting procedures for applying for circulation registration under new risk levels. Import medical devices granted customs clearance and domestically manufactured medical devices finished before December 31, 2020 that are specified in this Clause shall be circulated for the rest of the useful life of the products.
11. 69 ASEAN common submission document templates (CSDT) shall be applied from January 1, 2022. From January 1, 2022, applicants for issuance of registration number are not required to provide documents specified in Points g, i and m Clause 1 Article 26 of this Decree.
12.70 Facilities manufacturing medical gas must fully adopt ISO 9001 quality control systems or equivalent from January 1, 2020. Minister of Health shall elaborate quality control of medical gas.
13. 71 Materials, software, components and medical gas are not required to be registered for circulation and import permit as specified in this Decree.
Article 69. Responsibilities for guidance and implementation
1. Minister of Health is responsible for guiding, organizing and examining implementation of this Decree.
2. Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of People’s Committees of provinces and central-affiliated cities, and relevant organizations and individuals are responsible for implementation of this Decree./.
| CERTIFIED BY PP. MINISTER |
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