| Số hiệu | 19/2021/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y Tế |
| Ngày ban hành | 16/11/2021 |
| Người ký | Đỗ Xuân Tuyên |
| Ngày hiệu lực | |
| Tình trạng |
|
MINISTRY OF
HEALTH OF VIETNAM |
SOCIALIST
REPUBLIC OF VIETNAM |
|
No. 19/2021/TT-BYT |
Hanoi, November 16, 2021 |
CIRCULAR
On templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices;
At the request of the Director of the Department of Medical Equipment and Construction,
The Minister of Health hereby promulgates a Circular on templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices.
Article 1. Scope
This Circular provides for templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices.
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Organizations and individuals involved in activities relating to medical devices, including: classification of medical devices; production, clinical research, circulation, purchase, sale, export, import, and service provision of medical devices; advertising of medical devices; management of prices of medical devices, and management and use of medical devices at health facilities.
Article 3. Templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Templates of documents and reports enclosed herewith in Appendices include:
1. Appendix I: Template of written declaration of, disclosure of, statement of, notification of or application for issuance of marketing authorization number, import license and certificate of free sale.
2. Appendix II: Personnel list template.
3. Appendix III: Template of confirmation of work period.
4. Appendix IV: Template of medical device application for declaration, certificate, import license.
5. Appendix V: Template of classification results.
6. Appendix VI: Template of letter of authorization
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8. Appendix VIII: Template of technical document for medical devices.
9. Appendix IX: Template of report on receipt, dispatch, inventory, use of medical devices, production materials, EQA reagents that contain narcotics/precursors.
10. Appendix X: Template of written commitment and application for resumption of circulation of medical devices.
11. Appendix XI: Template of clinical research on medical devices.
Article 4. Responsibilities for implementation
Organizations and individuals involved in activities relating to medical devices are responsible for implementation of this Circular.
Article 5. Implementation provisions
1. This Circular comes into force from January 01, 2022.
2. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration and settlement.
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PP. MINISTERDEPUTY MINISTERDo Xuan Tuyen
APPENDIX I
Template of declaration of, disclosure of, statement of, notification of and application for issuance of number of marketing authorization, import license and certificate of free sale(enclosed with Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health)
Template No. 01
Declaration of eligibility for production of medical devices
Template No. 02.01
Declaration of applied standards of class A medical devices
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Declaration of applied standards of class B medical devices
Template No. 03.01
Application for issuance of marketing authorization numbers of class C and class D medical devices subject to national technical regulations
Template No. 03.02
Application for issuance of marketing authorization numbers of class C and class D medical devices which are measuring instruments subject to sample approval
Template No. 03.03
Application for issuance of marketing authorization numbers of class C and class D medical devices eligible for quick issuance
Template No. 03.04
Application for issuance of marketing authorization numbers of class C and class D medical devices eligible for emergency use authorization
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Application for issuance of marketing authorization numbers of other class C and class D medical devices
Template No. 04
Declaration of eligibility for trading of medical devices
Template No. 05
Application for medical device import licence
Template No. 06
Declaration of eligibility for provision of medical device consulting services
Template No. 07
Application for certificate of free sale of the medical devices
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Notification of updated information in application for declaration of eligibility for production of medical devices
Template No. 09
Notification of updated information in application for declaration of applied standards of class A and class B medical devices
Template No. 10
Notification of updated information in application for marketing authorization of class C and class D medical devices
Template No. 11
Notification of updated information in application for declaration of eligibility for trading of class B, class C and class D medical devices
Template No. 12
Notification of updated information in application for declaration of eligibility for provision of medical device consulting services
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Quotation for medical devices
Template No. 13.01
Updated quotation for medical devices
Template No. 14
Disclosure of medical device advertising contents and formats
Template No. 15
Declaration of materials used for production of medical devices and EQA reagents that contain narcotics/precursors
APPENDIX II
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SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------…....1....., day.......month.......year 20.....
personnel list
Name of facility: …………………………………………………………………………..
Address:…………………………………………………………………………..
No.
Full name
Position
Professional qualification
Process of working in the medical device-related field
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Work unit
Work period
Designated position
Main assigned tasks
Name of training institution
Training major
Qualifications
Training type
Training duration
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2
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3
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Legal representative of the facility(Signature (full name, title))Confirmed by seal or digital signature
___________________
1Geographic name.
APPENDIX III
Application for cONFIRMATION of work period template(Enclosed with Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health of Vietnam)
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
Application for cOnfirmation of work period
To:…………1………………..
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Date of birth:……………………………………………….
ID/passport: ………..date of issue: ……………………. Place of issue: ........................
I would like to have the following information confirmed:
I have worked or have been working at:……………………………………….
Working period: from ……(date)…… to ……(date)..................
Designated position:…………………………………………
Main assigned tasks:……………………………………..
.............................................................................................................................
.............................................................................................................................
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Sincerely!
…..2….., day… month… year 20……confirmation of EMPLOYER(signature, full name, confirmation)
APPLICANT(signature and full name)
___________________
1Name of the employer.
2Geographic name
APPENDIX IV
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Template No. 01
Template of application for declaration of eligibility for production of medical devices
Template No. 02.01
Template of application for declaration of applied standards of class A medical devices
Template No. 02.02
Template of application for declaration of applied standards of class B medical devices
Template No. 03
Certificate of marketing authorization of class c and class D medical devices
Template No. 04
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Template No. 05
Medical device import license
Template No. 06
Template of application for declaration of eligibility for provision of medical device consulting services
Template No. 07
Certificate of free sale of medical devices
Template No. 08
Template of application for declaration of materials used for production of medical devices and EQA reagents that contain narcotics/precursors
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TEmplate of medical device classification results(enclosed with Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health)
FACILITY’S NAME-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
….1…, day….month…..year 20…..
medical device classification results
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices;
Pursuant to Circular No. 39/2016/TT-BYT dated October 28, 2016 of the Ministry of Health elaborating classification of medical devices.
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No.
Name of medical device
Category/ code of product
Manufacturer, country of production
Manufacturer, country of product owner
Uses according to the owner’s assignation
Grounds for risk classification
Risk level
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Legal representative of classifying facility(Signature (full name, title))Confirmed by seal or signature
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1Geographic name
APPENDIX VI
LETTER OF authorization TEMPLATE(Enclosed with Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health of Vietnam)
Headline (name and address) of the owner of the medical device
Day ………month…….. year 20 ....................
Letter of authorization
To: ……………………………………………………
We, (name and address of the Product Owner), as the owner of the medical devices listed hereunder, hereby authorize (name and address of the organization authorized to announce applicable standards in its name or register for circulation) to place/ register the following medical devices to the market of Vietnam:
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We hereby commit to provide and support any inquiry related to the information and quality of the medical devices, guarantee all warranty, maintenance and service conditions and supply replacement materials and accessories for the medical devices.
This Letter of Authorization is valid until: ….. date (dd/mm/yy)
Legal representative of the ownerSignature (full name, title)Confirmed by seal or signature
APPENDIX VII
Confirmation of eligibility for warranty teMPLATE(Enclosed with Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health of Vietnam)
Headline (name and address) of the owner of the medical device: …………………
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CONFIRMATION OF ELIGIBILITY FOR WARRANTY
Name: …………………………………..
Address:…………………………………………………………………………..
As the owner of the medical device, we confirm that the below-named facilities are eligible for warranty on the medical device of …..1……………
Name of medical device
Name of warranty facility
TIN
Address
Landline
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Facility 1
Facility 2
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Facility 1
Facility 2
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Facility 3
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Legal representative of the ownerSignature (full name, title)Confirmed by seal or signature
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1Full name of the owner of the medical device
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Templates of technical documents for medical devices(enclosed with Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health)
As for medical devices which are reagents, calibration substances, in vitro control materials
Template No. 01
Technical documents for reagents, calibration substances, in vitro control materials
As for chemicals and preparations serving the only purpose of disinfecting medical devices
Template No. 02
Documentation of brief technical description of chemicals and preparations serving the only purpose of disinfecting medical devices
As for medical devices which are neither reagents, calibration substances, in vitro control materials nor chemicals and preparations serving the only purpose of disinfecting medical devices
Template No. 03
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Template No. 04
Documentation of brief technical description of imported medical devices
As for materials used for production of medical devices and EQA reagents that contain narcotics/precursors
Template No. 05
Technical documents on materials used for production of medical devices and EQA reagents that contain narcotics/precursors
APPENDIX IX
Template of report on receipt, dispatch, inventory, use of medical devices, production materials, EQA reagents that contain narcotics/precursors(enclosed with Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health)
FACILITY’S NAME-------
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No. ………..
REPORT ON RECEIPT, DISPATCH, INVENTORY, USE IN ............Of medical devices and EQA reagents that contain narcotics/precursors
To: ……………………………………………………
No.
Name of medical device/ production material/ EQA reagent
Number of declaration
Narcotic/ precursor
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CAS code
Content in a smallest packing unit
Unit
Remaining quantity of the previous period
Received quantity
Used1
Dispatched quantity
Remaining quantity at the end of the current period
Loss2
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This report is enclosed with the detailed list of names and addresses of customers, and names and quantity of narcotics/ precursors dispatched in the year.
…….(location), day…… month……year…….Legal representative of the facilitySignature (full name, title)Confirmed by seal or signature
___________________
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2Including the quantity of destroyed products and expired products, etc. If any, a detailed report is required
APPENDIX X
Template of written commitment and application for resumption of circulation of medical devices(enclosed with Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health)
Template No. 01
Template of applications for resumption of circulation of medical devices and written commitments to take responsibility for warranty, preservation, provision of materials for the use of medical devices
Template No. 02
Template of written consents for resumption of circulation of medical devices
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Template of clinical research on medical devices
Template No. 01
Application for approval for clinical research on medical devices
Template No. 02
Description of clinical research on medical devices
Template No. 03
Certificate of approval for clinical research protocol
Template No. 04
Decision on approval for clinical research protocol on medical devices
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Application for approval for revised clinical research protocol on medical devices
Template No. 06
Certificate of approval for revised clinical research protocol
Template No. 07
Decision on approval for revised clinical research protocol on medical devices
Template No. 08
Application for approval for results of clinical research on medical devices
Template No. 09
Report on results of clinical research on medical devices
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Certificate of approval for results of clinical research on medical devices
Template No. 11
Decision on approval for results of clinical research on medical devices
Template No. 01
FACILITY’S NAME-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. /…..Re. application for approval for clinical research on medical device
Hanoi, day month year 20…
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Name of the clinical research facility (CRF):
Address of the CRF:
Tel: Fax:
Email:
Full name of the principal researcher:
Tel: Email:
We hereby request the Ministry of Health to approve the clinical research on medical device including the following contents:
- Phase of clinical research:
- Name of medical device
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- Type of medical device:
- Name of manufacturer:
- Address of manufacturer:
- Name of owner of medical device:
- Address of owner:
Enclosures:
1.
2.
The CRF and principal researcher hereby declare that there is no conflict of interests between parties in the research, and they will comply with the research protocol approved by the Ministry of Health, comply with the good clinical practice – GCP and regulations on clinical researches on medical device.
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Principal researcher(signature)
Head of the CRF(signature and seal)
Template No. 02
Ministry of Health
Explanation of clinical research protocol on medical device
I. General information on clinical research on medical device
1. Name of the research
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2. Code (written by supervisory authority)
3. Duration:
(form …(month)…./20.. to …(month)….20..)
4. Managerial level:
State * Ministry/Province *
5.
Funding
Total:
Sources of funding ……….
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6
Phase of clinical research:
7
Principal researcher:
Full name:
Academic title/ academic qualification:
Scientific title:
Tel: (CQ)/ (NR) Fax:
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Email:
Office address:
Home address:
8
Research organization
Name of organization:
Tel: Fax: Email:
Address:
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9
Copyright holder (the organization that holds the copyright of the proposed device and uses the clinical research result to put the device into mass production, operation, or initiate the next phase of research):
Name of organization
Tel: Fax: Email:
Office address:
Full name(for individuals):
Academic title/ academic qualification:
Scientific title:
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Mobile phone:
Email:
Office address:
Home address:
II. Contents of clinical research on medical device
(provide description of each phase according to requirements of the Instruction on clinical research on medical devices)
10
Goals:
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11
Current status of the clinical research on medical device in Vietnam and abroad.
□ Current status * New research * Next phase
□ Detailed description of medical device (manufacturing technology, technical features, product quality, process of use, operation, assessment methods, possible risks and hazards and measures to ensure safety for researchers and participant)
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Abroad:
In Vietnam:
□ List of relative clinical researches on medical devices published within the last 10 years.
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12
Approach, method and technique(clearly justify approach - research design, selection of sample, sample size, criteria for selecting research subject, research method, technique to be used - compare with other similar solutions, research criteria, technical means and equipment to determine research criteria; state the novelty, originality and creativity of this research design and research method)
12.1 Research site:
12.2 Research duration:
12.3 Research method:describe the type of evaluation, (randomized, blinded, open), evaluation design (parallel groups, matched pairs), blinding technique (double-blind, single-blind), method and process of randomization.
12.4 Research subject:describe the research subject (standards of selection and elimination of potential subjects), standard operating procedures (SOPs) for the selection of the subject: method, standard and point of time of appointing the subject to the research group.
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12.5 Sample size:the required number of subjects to reach the goal of evaluation, based on the statistics.
12.6 Medical device to be evaluated:Briefly describe the medical device to be evaluated, including name of the medical device, category, applied technology, main specifications, indications and applications. The specific information on batches of medical devices used in the research: name, manufacturer, batch number, date of manufacture, expiry date, proof of quality inspection. Packing, labelling, storage, preservation, transport, instructions for use and notes during the process of use of the medical device. Analyses and assessments of the risk level/ benefits from use of the medical device, latent side effects of the medical device and suitable safety solutions for patients and health workforce.
12.7 Regimen of proposed device:
12.8 Polytherapy:any other treatments that could have been defined or allowed to be used at the same time.
12.9 Research data and ways to collect research data.
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12.10 Adverse event recording and reporting:The method for recording and reporting cases of adverse reactions (ARs) or adverse events (AEs) and compliance-related clauses.
12.11 Adverse event processing
12.12 Standards of elimination of the subject in the process of research:Standards of elimination for the research subject and instructions for termination of whole or part of the research.
12.13 Blinding technique and protection of identification of the research subject:procedures for maintaining subject identification lists, clinical records, lists of randomly selected subjects and/or case report forms (CRFs). These records must allow separation of patients and participants, as well as data inspection and acquisition.
12.14 Code breaking:information regarding the establishment of trial codes, information regarding where the list is stored, who is allowed to perform code break, when and how the code break is allowed in the event of a medical emergency.
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12.15 Method of data processing and outcome evaluation:describe methods used to evaluate outcomes (including statistical methods) and reports on patients or participants dropping out of the evaluation.
12.16 Method of information provision for subjects:Information provided for subjects for evaluation, including which information they will be provided, and when and how their consent forms are collected.
12.17 Training for research groups:training for researchers involved in the clinical research (including: research leader, sub-leader, coordinator, researchers, pharmacists, nurses, technicians) including: Basics of the research, information on how to conduct evaluation, standard operating procedures (SOPs) for management and use of the proposed medical devices.
12.18 Issues concerning ethics:considerations and ethics-related measures concerning the evaluation. (including: methods, procedures for selection of research subjects, Informed Consent Form (ICF)/Information letter and consent form, Research Ethics position statement).
12.19 Post-evaluation health care:health care provided after evaluation and treatment methods used after evaluation.
12.20 Plans
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- Supervision of the principal researcher and the research group
- Supervision by donors
- Supervision and inspection by supervisory authorities, Research ethics committee (REC).
12.22. SOPs of the research
13
Research contents(list and describe contents to be researched, concentrate on new and contents suitable to solve stated issues and attain mentioned research goals, including planned joint operations to transfer research results to users)
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- Task 1:
- Task 2:
- ........
13.2. Content 2:
- Task 1:
- Task 2:
- ........
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14
International cooperation
Name of partner
Cooperation contents
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15
Progress
No.
Main contents and tasks(Important milestones)
Target products
Starting time – Ending time
Authority/ Participants
1
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3
4
5
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16
Expected results
□ Diagram
□ Data table
□ Analysis reports, conclusions of effect, suitability and safety of the medical device
□ Forecasts for the next phase of the clinical research
□ Instructions for use of the medical device.
□ Process
□ Other products
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Product requirements
No.
Product name
Scientific name
Remark
(1)
(2)
(3)
(4)
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2
3
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18
Method for transfer of research results
19
Impacts of research results(in addition to the impacts mentioned in section 18 above)
□ Training and refresher training for Science and technology officers
□ As for related scientific fields:
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□ As for society and economy:
IV. Organization/individual participating in the clinical research on the medical device
20
Activities of cooperating organizations.
(specify all organizations cooperating in conducting the research and their tasks)
No.
Name of the organization
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Activities/ contributions to the research
1
2
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3
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21
Connection with manufacture and life
(Specify manufacturer or users of research results participating in the process and specify their tasks)
22
Research personnel
(Specify up to 10 persons making major contributions of all presiding and participating organizations)
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Full name
Workplace
Percentage (%) of working period for the research
a
Principal researcher
B
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2
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Officials participating in the research
V. Funding and sources of funding
(see the attached Appendix for detail explanations)
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23
Sources of funding for different expenditures
No.
Source of funding
Total
Including
Services
Materials, energy
Device, machinery
...
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Others
1
2
3
4
5
6
7
8
...
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...
1
2
Total funding
Where:
Science budget
Other capital sources (specify)
...
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- Equity
- Others (mobilized capitals, etc.)
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Head of the research organization(full name, signature and seal)
Principal researcher(full name and signature)
....... …(location)………(date) ....................Director Generalof the Administration of Science, Technology and Training
estimated costs of the clinical research
Unit: million VND
No.
Items of expenditures
...
...
...
Capital source
Funding
Percentage (%)
Science budget
Donation
Others
1.
Services
...
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...
2.
Materials and energy
...
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...
3.
Special-use machinery/ equipment
4.
Construction, minor repair
...
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5.
Others
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Total
Explanations of expenditures(million VND)
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No.
Description
Total funding
Capital source
Science budget
Donation
Others
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Total
Clause 2. Materials and energy
No.
Content
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Quantity
Unit price
Amount
Capital source
Science budget
Donation
Others
2.1
Materials
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2.2
Tools, spare parts
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2.3
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- Coke
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- Electricity
kW/h
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- Gasoline
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...
- Others
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2.4
Water
m3
...
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2.5
Books, documents and data
...
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Total
Clause 3. Special-use machinery/ equipment
No.
Content
...
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...
Quantity
Unit price
Amount
Capital source
Science budget
Donation
Others
3.1
Technological devices
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3.2
Evaluation and measurement instruments
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3.3
Equipment depreciation
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3.4
Equipment rental
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3.5
Transport and installation
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Clause 4. Construction, minor repair
No.
Content
Funding
Capital source
...
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...
Donation
Others
4.1
Expenditures of construction of .....square meters of space for workshops, laboratories
4.2
...
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4.3
Expenditures of installation of electricity/water system
...
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4.4
Others
...
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Total
Clause 5. Other expenditures
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Content
Funding
Capital source
Science budget
Donation
Others
5.1
Business trip expenses
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5.2
Management expenses
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5.3
Costs of evaluation, inspection and acceptance
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- Appraisal costs
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- Supervision costs
...
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- Costs of intermediate inspection and acceptance
- Costs of internal inspection and acceptance
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- Costs of official inspection and acceptance
5.4
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- Training
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- Conferences
- Printing of documents and office stationery
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- Translation of documents
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5.5
Allowances for researchers
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Total
Informed Consent Form (ICF)
Name of the research:
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Name of the organization or individual having the proposed medical device:
Subject code:…………………………..
This document is fully notified to subjects involved in the research. Do not skip any page or part of this document. Contents of this document must be verbally explained to subjects involved in the research.
1. Description of issues relating to the research, research purpose, scheduled duration and method (specify subjects to be evaluated)
2. Standards of selection of subjects
3. Standards of removal of subjects from the research
4. Who will be the assessor of personal information and medical information to select you to participate in this research?
5. Number of subjects involved in the research
6. Description of risks or adverse conditions
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8. Payments you will receive during the research
9. Substitution therapies or treatments
10. Storage method of keeping personal documents secure
11. Inspectors and supervisors of your application, etc.
12. Compensation or caring and treatment in case a health issue occurs
13. Persons that you can contact when you have any question relating to the research
Your participation in the research is voluntary and you are entitled to refuse to participate or stop participating at any point of time during the research but your medical care still be ensured.
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Informed consent form (ICF)
(For subjects involved in the research)
I, ……………………………………………………………………………….
hereby declare that
I have read all the provided information about the research ……………………….. in the ICF, edition….., dated ….., with ….. pages).
I have been given clear explanations for the research and procedures for registering voluntary participation in the research by the researchers.
I have had opportunities for addressing questions about the research and I get a great deal of satisfaction from the given answers.
I have had a time and opportunity to consider participating in this research.
...
...
...
I have understood that I can withdraw from the research at any point of time for any reason.
I agree that doctors who are providing me with treatment (if any) will be notified of this participation in the research.
I agree/disagree to participate in this research, tick to the appropriate box:
Agree:
Disagree:
...
...
...
………………………………………….....................
Day/month/year
…………................…
If required,
* Signature of the witness
………………………………………….....................
Day/month/year
…………................…
...
...
...
………………………………………….....................
Signature of the person who provides research information and takes the ICF
………………………………………….....................
Day/month/year
…………................…
Name of the person who provides research information and takes the ICF
………………………………………….....................
...
...
...
INFORMED CONSENT FORM (ICF)
(For legal guardians of participants in the research)
I (write full name in block capitals): …………………………………………………………….
am (specify the relation with the participant in the research) ………………… and am a legal guardian of (write full name of the participant in the research in block capitals) …………………………
hereby declare that
( I have read all the provided information about the research ……………………….. in the ICF, edition….., dated ….., with ….. pages).
I have been given clear explanations for the research and procedures for registering voluntary participation in the research by the researchers.
I have had opportunities for addressing questions about the research and I get a great deal of satisfaction from the given answers.
I have had a time and opportunity to consider permitting my ……….. who is …………….. to participate in this research.
...
...
...
I have understood that my ……………. can withdraw from the research at any point of time for any reason.
I agree that doctors who are providing my ……….. with treatment (if any) will be notified of this participation in the research.
I agree/disagree to let my ……… participate in this research, tick to the appropriate box:
Agree:
Disagree:
...
...
...
………………………………………….....................
Day/month/year
…………................…
If required,
* Signature of the witness
………………………………………….....................
Day/month/year
…………................…
...
...
...
………………………………………….....................
Signature of the person who provides research information and takes the ICF
………………………………………….....................
Day/month/year
…………................…
Full name of the person who provides research information and takes the ICF
………………………………………….....................
...
...
...
Template No. 03
Ministry of HealthNational Biomedical Research ethics committee (REC)-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. /CN-HDDD
Hanoi, day month year 20…
CERTIFICATE
of REC’s approval
Pursuant to Decision No. ............/QD-BYT dated …………. of the Minister of Health on the establishment of the REC for the tenure of …..;
...
...
...
Pursuant to Document No. ......./BB-HDDDQG dated …………. of the REC;
The REC hereby approves the clinical research protocol in terms of ethics and science:
1. Name of the research: ………………………………………..
2. The principal researcher: ………………
3. The CRF: …………………………
4. Research site: ………………………………………………
5. Research subjects: ……………………………………………………………………………………..
6. Estimated number of subjects: ……………………………………
7. Duration of the research: ……………………………………..
...
...
...
Changes during the research must be considered and approved by REC, unless such these changes are necessary to eliminate direct risks to the subjects.
The principal researcher and CRF must report adverse events and extremely adverse events to the REC in accordance with applicable regulations.
Chairperson of the REC
Template No. 04
MINISTRY OF HEALTH OF VIETNAM-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
...
...
...
Hanoi, day month year 20….….
DECISION
On approval for clinical research protocol
MINISTER OF HEALTH
Pursuant to Decree No. …………/ND-CP dated…………………. of the Government on functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices;
Pursuant to Circular No. .............../TT-BYT dated ………………, 2021 of the Ministry of Health on ……………………………….;
Pursuant to Circular No. 04/2020/TT-BYT dated March 05, 2020 of the Minister of Health on establishment, functions, tasks and powers of REC;
...
...
...
HEREBY DECIDES:
Article 1.Approval for clinical research protocol on medical devices
1. Name of the research: ………………………………………..
2. Phase of the research: ………………………………………..
3. The principal researcher: ………………
4. The CRF: …………………………
5. The sponsor:……………………………………………..
6. Name of the manufacturer: ……………………………….
7. Research site: ………………………………………………
...
...
...
9. Estimated number of subjects: ……………………………………
10. Duration of the research: ……………………………………..
11. Estimated cost: …………………………..
12. Source of funding: ………………………………
Article 2.Head ofCRF must ensure adherence to Good Clinical Practice (GCP) throughout the research. The Chairperson of the REC shall monitor and supervise the compliance with the approved clinical research protocol, assess the recognition, handling, report and monitoring of adverse events occurring during the research. The principal researcher and research group shall conduct the research in conformity with the approved clinical research protocol and applicable regulations. The sponsors shall manage, support and supervise the research to have its quality ensured and the research data authenticated.
Article 3.TheHead of the CRF, the Chairperson of the REC at the grassroots level, the principal researcher and the sponsor shall comply with all regulations of the State on scientific and technological activities, research service agreements and financial expenditures; comply with GCP guidelines and applicable relevant regulations, thereby ensuring the perfect safety for subjects involved in the research.
Article 4.This Decision comes into force from the day on which it is signed.
Article 5.Directors of the Administration of Science, Technology and Training, the Chairperson of the REC, the Head of the CRF and Heads of relevant units are responsible for implementation of this Decision.
...
...
...
Position of the approverSignature (full name, title)Confirmed by seal or signature
Template No. 05
FACILITY’S NAME-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. /……..Re. application for approval for changes in the clinical research protocol
Hanoi, day month year 20….
To: The Ministry of Health (Administration of Science, Technology and Training)
...
...
...
Address of the CRF:
Tel: Fax:
Email:
Full name of the principal researcher:
Tel: Email:
We have been permitted to conduct the clinical research on medical devices [name of the research] by the Ministry of Health at Decision No. /QD-BYT dated ……………………
We hereby request approval for the following changes:
No
Changes
...
...
...
List of documents concerning the changes
1.
2.
...
...
...
Enclosures:
....
After studying Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices, including regulations on clinical research on medical devices and relevant regulations, we hereby declare that we will fully comply with legal documents, professional regulations and code of ethics in research. We request the Ministry of health (via the Administration of Science, Technology and Training) to consider and approve the above-mentioned changes of the facility.
Principal researcher(signature)
Head of the CRF(signature and seal)
...
...
...
Template No. 06
MINISTRY OF HEALTHRESEARCH ETHICS COMMITTEE (REC)-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. /CN-HDDD
Hanoi, day month year 20…
CERTIFICATE
of REC’s approval for changes in the research
Pursuant to Decision No. ............/QD-BYT dated …………. of the Minister of Health on establishment of REC for the tenure of …..;
...
...
...
Pursuant to Decision No. ............/QD-BYT dated …………. of the Minister of Health on approval for the clinical research protocol “Name of the research";
At the request of "CRF's name" at Official Dispatch No. ……………. dated …………….. on application for amendments to the research,
The REC hereby approves use of the following documents instead of their previous editions:
No.
Name of document
Edition/date
1
Explanation of the protocol
- Vietnamese edition . ……………, published on day… month.... year....
...
...
...
Clinical research protocol
- Revised Vietnamese edition . ……………, published on day… month.... year....
- English edition . ……………, published on day… month.... year.... (if any)
3
………………..
Approval date: (dd/mm/yyyy)….…...….
Changes in the conduct of the research requiring consideration and approval of the REC, except if changes are necessary to eliminate direct risks to the subjects.
The principal researcher must report adverse events and extremely adverse events to the REC in accordance with applicable regulations.
...
...
...
CHAIRPERSON OF THE REC
Template No. 07
MINISTRY OF HEALTH OF VIETNAM-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. /QD-BYT
Hanoi, day month year 20….….
...
...
...
On approval for revised clinical research protocol
MINISTER OF HEALTH
Pursuant to Decree No. ……./ND-CP dated ……………. of the Government on functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Pursuant to Circular No. .............../TT-BYT dated ………………, 2021 of the Ministry of Health on ……………………………….;.
Pursuant to Circular No. 04/2020/TT-BYT dated March 05, 2020 of the Minister of Health on establishment, functions, tasks and powers of REC;
At the request of the Director of the Administration of Science, Technology and Training affiliated to the Ministry of Health.
HEREBY DECIDES:
Article 1.Approval for the revised clinical research protocol:
...
...
...
The principal researcher: ………………
The CRF: …………………………
Research site: ................................................
Revised contents in the Explanation of the clinical research protocol, edition …………………, published on ......... [date]............, include:
1. ......................................
2. ......................................
3. ......................................
Article 2.Head of CRF must ensure compliance to GCP throughout the research. The Chairperson of the REC shall monitor and supervise the compliance with the approved clinical research protocol, assess the recognition, handling, report and monitoring of adverse events occurring during the research. The principal researcher and research group shall conduct the research according to the approved clinical research protocol and applicable regulations. The sponsors shall manage, support and supervise the research to have its quality ensured and the research data authenticated.
Article 3.The Head of the CRF, the Chairperson of the REC at the grassroots level, the principal researcher and the sponsor shall comply with all regulations of the State on scientific and technological activities, research service agreements and financial expenditures; comply with GCP guidelines and applicable relevant regulations, thereby ensuring the perfect safety for subjects involved in the research.
...
...
...
Article 5.Directors of the Administration of Science, Technology and Training, the Chairperson of the REC, the Head of the CRF and Heads of relevant units are responsible for implementation of this Decision.
POSITION OF APPROVERSignature (full name, title)Confirmed by seal or signature
Template No. 08
FACILITY’S NAME-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. /…..Re. Application for approval for results of clinical research on the medical device
...
...
...
To: The Ministry of Health (Administration of Science, Technology and Training)
The CRF: …………………………
The cooperating facility in the research:
The principal researcher:
We hereby request the Ministry of Health (via the Administration of Science, Technology and Training) to consider and approve results of the clinical research on the medical device:
- Name of the research:
- Code of the research:
- Research duration:
...
...
...
- Name of the medical device:
- Category:
- Type of the medical device:
- Name of the manufacturer:
- Address of the manufacturer:
- Name of the owner of the medical device:
- Address of the owner:
Enclosures:
......
...
...
...
Principal researchersignature
Head of the CRFsignature and seal
Template No. 09
The cover page
MINISTRY OF HEALTH
...
...
...
Name of the research:
The principal researcher:
Research organization:
...
...
...
20
The title page
MINISTRY OF HEALTH
...
...
...
Clinical research report
Name of the research:
The principal researcher:
Research organization
Supervisory authority: the Ministry of Health
Code of the reseach (if any): …………………………..
...
...
...
Total funding for conducting the research: VND…………… million
Where: Science budget: VND …………. million
Others (if any): VND …………….. million
20
Page 3
...
...
...
1. Name of the research:
2. The principal researcher:
3. Research organization:
4. Supervisory authority: the Ministry of Health
5. The research secretary:
6. List of main performers:
-
...
...
...
-
7. Research sites
(a) Research site 1
- Site:
- The principal researcher:
(b) Research site 2
- Site:
- The principal researcher:
8. Research duration: from month …. year …. to month…. year …..
...
...
...
Page 4
Abbreviations
Table of contents
Part A. Abstract
Part B. Detailed contents of the report
1. Introduction:
1.1. Brief introduction of relevant researches in Vietnam and abroad
...
...
...
1.3 Assumptions of the research
1.4 Research objectives
2. Overall research design:
2.1. Relevant researches in foreign countries
2.2. Relevant researches in Vietnam
3. Research subjects and research methods:
3.1. Research design
3.2. Selection of samples, sample sizes and research subjects.
3.3. Research methods
...
...
...
3.3.2. Methods for determination of criteria of the research.
3.3.3. Specific research tools.
3.4. Method of data processing.
4. Results of the research:
4.1 Brief description of the proposed device, including function, model of the device, technology, characteristics and method of use.
4.2 Analysis of the selected documents and data, advantages and disadvantages.
4.3 Joint assessment of risks and danger and appropriate safety measures for patients and health workforce.
4.4 Assessments of cultural, geographical, and demographic factors (for example: age, nationality, gender, etc.).
4.5 Equivalent methods of use of the device on the same safety standards and considerations of ethics
...
...
...
5. Discussion:
6. Conclusion and recommendation:
7. References:
8. Appendix (if any):….
Template No. 10
MINISTRY OF HEALTHRESEARCH ETHICS COMMITTEE (REC)-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. /CN-HDDD
...
...
...
CERTIFICATE
Of results of clinical research on medical device
Pursuant to Decision No. ............/QD-BYT dated …………. of the Minister of Health on establishment of REC for the tenure of …..;
Pursuant to Decision No. ............/QD-BYT dated …………. of the Minister of Health on promulgation of the regulation on organization and operation of the REC for the tenure of …..;
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Pursuant to Decision No. ............/QD-BYT dated …………. of the Minister of Health on approval for the clinical research protocol “Name of the research";
At the request of "CRF's name" at Official Dispatch No. ……………. dated …………….. on application for amendments to the research,
Pursuant to Document No. …/BB-BNCDD dated …………. of the REC on assessment of results of the clinical research on the medical device;
...
...
...
1. Name of the research:
2. Phase of the research:
3. The principal researcher:
4. The CRF:
5. Name of the organization or individual having the proposed medical device:
6. Reseach site:
7. Research subjects:
8. Number of research subjects:
9. Research duration:
...
...
...
11. Manufacturer:
12. Instructions for use, regimen of the proposed product: according to the research protocol approved at Decision No. …/QD-BYT dated …………… of the Ministry of Health.
13. Date of acceptance meeting of the REC:
Approval date: (dd/mm/yyyy)…...….
CHAIRPERSON OF THE REC
Template No. 11
...
...
...
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. /QD-BYT
Hanoi, day month year 20….….
DECISION
On approval for results of clinical research on medical devices
MINISTER OF HEALTH
Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on function, tasks, powers and organizational structures of the Ministry of Health of Vietnam;
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices;
...
...
...
Pursuant to the Certificate of results of clinical research on medical device No. ……… dated …………. Of the REC;
At the request of the Director of the Administration of Science, Technology and Training affiliated to the Ministry of Health.
HEREBY DECIDES:
Article 1.Approval for results of clinical research on medical devices:
1. Name of the research: ………………………………………..
2. Phase of the research: ………………………………………..
3. The principal researcher: ………………
4. The CRF: …………………………
4. Name of the medical device:…………………………………
...
...
...
6. Type of the medical device: ………………………………………….
7. Name of the owner of the medical device:………………
8. The owner’s address: …………………………………………………………………………..
9. The sponsor: ……………………………….
10. Name of the manufacturer: …………………………………………………………………
11. Address of the manufacturer: ......................................................................................
12. Research site: ................................................
13. Research subjects: ………………………………………..
14. Estimated number of research subjects: ………………………………………..
...
...
...
16. Procedures and instructions for use of the medical device: …………………………..
17. The REC’s conclusion of the acceptance of the results: ……………………
Article 2.This Decision comes into force from the day on which it is signed.
Article 3.Directors of the Administration of Science, Technology and Training, the Chairperson of the REC, the Head of the CRF and Heads of relevant units are responsible for implementation of this Decision.
POSITION OF THE approverSignature (full name, title)Confirmed by seal or signature
...
...
...
| Số hiệu | 19/2021/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y Tế |
| Ngày ban hành | 16/11/2021 |
| Người ký | Đỗ Xuân Tuyên |
| Ngày hiệu lực | |
| Tình trạng |
Bạn chưa có tài khoản? Hãy Đăng ký
| Số hiệu | 19/2021/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y Tế |
| Ngày ban hành | 16/11/2021 |
| Người ký | Đỗ Xuân Tuyên |
| Ngày hiệu lực | |
| Tình trạng |