| Số hiệu | 10/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y tế |
| Ngày ban hành | 11/05/2023 |
| Người ký | Đỗ Xuân Tuyên |
| Ngày hiệu lực | |
| Tình trạng |
|
MINISTRY OF
HEALTH OF VIETNAM |
SOCIALIST
REPUBLIC OF VIETNAM |
|
No. 10/2023/TT-BYT |
Hanoi, May 11, 2023 |
CIRCULAR
AMENDMENTS TO CERTAIN ARTICLES OF CIRCULAR NO. 19/2021/TT-BYT DATED NOVEMBER 16, 2021 OF THE MINISTER OF HEALTH 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. 95/2022/ND-CP dated November 15, 2022 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 Decree No. 07/2023/ND-CP dated March 03, 2023 of the Government on amendments 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 amendments to certain Articles of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health 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. Amendments to Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health 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
...
...
...
a) Template No. 02.01; Template No. 02.02; Template No. 03.01; Template No. 03.02; Template No. 03.03; Template No. 03.04 and Template No. 03.05 are amended.
b) Template No. 05.A and Template No. 05.B are added.
2. Amendments to Clause 4 of Article 3 concerning regulations in Appendix IV:
a) Template No. 02.01; Template No. 02.02; Template No. 03; Template No. 05; Template No. 07 are amended.
b) Template No. 05.A and Template No. 05.B are added.
3. Addition of Clause 6a to Article 3:
“6a. Appendix VI.A: Template of Letter of authorization of issuance of medical device import licences according to regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP.”
4. Amendments to Clause 8 of Article 3 concerning regulations in Appendix VIII:
a) Template No. 04 is amended.
...
...
...
Article 2. Transitional regulations
1. Documents contained in dossiers on declaration of applied standards or applications for certificates of marketing authorization or applications for import licences that are submitted before the day on which this Circular comes into force shall be continued to be applied to issue numbers of marketing authorization and import licences, unless amendments to such dossiers and applications are required.
2. If letters of authorization using the prescribed template are signed for promulgation by medical devices' owners before the day on which this Circular comes into force, they shall be continuously included in applications for medical device import licences.
Article 3. Implementation clauses
1. This Circular comes into force from the day on which it is signed.
2. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration and settlement./.
...
...
...
APPENDIX I
TEMPLATE OF DECLARATION OF, DISCLOSURE OF, STATEMENT OF, NOTIFICATION OF AND APPLICATION FOR ISSUANCE OF MARKETING AUTHORIZATION NUMBER, IMPORT LICENCE AND CERTIFICATE OF FREE SALE (enclosed with Circular No. 10/2023/TT-BYT dated May 11, 2023 of the Minister of Health)
Template No. 02.01
Declaration of applied standards of class A medical devices
Template No. 02.02
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
...
...
...
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
Template No. 03.05
Application for issuance of marketing authorization numbers of other class C and class D medical devices
Template No. 05.A
Applications for medical device import licences serving the implementation of the regulations in Clause 8 Article 1 of Decree No. 07/2023/ND-CP dated March 03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices (hereinafter referred to as "Decree No. 07/2023/ND-CP”)
...
...
...
Orders for import of biological products for in vitro diagnostic tests serving the implementation of the regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP
Template No. 02.01
FACILITY’S NAME-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
…1………, day……..month……….year 20……
DECLARATION OF APPLIED STANDARDS of class A medical Devices
...
...
...
1. Name of declarant:……………………………………………………………………………
TIN or number of Licence for representative office establishment: ……………….
Address:…………………………..3………………………….
Landline: ………………………. Fax:……………………………..
Email:……………………………………
2. Legal representative of the facility:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of issue: ........................
Landline:………………………….Mobile phone: ……………………….
...
...
...
General medical device4: * or IVD medical device: *
Name of the medical device5:……………………
Trade name6(if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if any): …………..
Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
Packing specification (if any): ……………………………………….
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
...
...
...
Applied standard: ....................................................
4. For medical device that contains narcotic or precursor:
Name of the narcotic or precursor: …………..Scientific name: …………………
CAS Registry Number: ……………………………………………………..
Concentration and content of the narcotic or precursor: .....................
Total content of narcotics and precursors in a smallest packing unit:
……………………………………………………………………………………………………….
5. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
...
...
...
6. Information about warranty facility (if any):
Name of facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
7. Number of declaration of eligibility for domestic production of medical devices:
……………………………………………………………………………………………………….
Declaration of applied standards of class A medical device
Enclosures:
1.
...
...
...
*
2.
Letter of authorization of the owner of the medical device
*
3.
Confirmation of eligibility for warranty
*
4.
Documentation of brief technical description of the medical device in Vietnamese
...
...
...
5.
Technical documentation of functions and specifications of the medical device promulgated by its owner
*
6.
Technical documents in Vietnamese enclosed with documents on materials, product safety, manufacturing process and clinical and preclinical research reports including reports on the stability of reagents, calibrators and in vitro control materials.
*
7.
Standard version declared to be applied by the owner of the medical device
*
...
...
...
Certificate of conformity with standards
*
9.
For a medical device manufactured in Vietnam: result of evaluating chemical, physical and microbiological parameters and other parameters granted by a qualified facility according to the provisions of law on conformity assessment, or Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical devices
*
10.
User manual of the medical device in Vietnamese; for an imported medical device, an original in English, issued by the owner of the medical device, will be enclosed with the user manual in Vietnamese.
*
11.
...
...
...
*
12.
Certificate of free sale for the imported medical device
*
We hereby declare that:
1. The declared information is accurate and legal according to the regulations. We will wholly be responsible for any falsification and will face penalties according to regulations of law.
2. We ensure the quality of the medical device and trade thereof according to the declaration.
3. Any changes related to the declaration will be updated in accordance with regulations.
...
...
...
Legal representative of the facilitySignature (full name, title)Confirmed by seal or signature
___________________
1Geographic name
2Department of Health of the province where the facility is located
3The address written on the business registration certificate
4Non-IVD medical device
5Specify name of the medical device in Vietnamese in accordance with uses of the medical device, unless its name cannot be translated into Vietnamese.
...
...
...
Template No. 02.02
FACILITY’S NAME-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
…1………, day……..month……….year 20……
DECLARATION OF APPLIED STANDARDS OF CLASS B MEDICAL DEVICES
To: …………………………2…………………………
...
...
...
TIN or number of Licence for representative office establishment: ……………….
Address:…………………………..3………………………….
Landline: ………………………. Fax:……………………………..
Email:……………………………………
2. Legal representative of the facility:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Class B medical device:
...
...
...
Name of the medical device5:…………………………………
Trade name6(if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if any): …………..
Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
Packing specification (if any): ……………………………………….
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
...
...
...
4. For medical device that contains narcotic or precursor:
Name of the narcotic or precursor: …………..Scientific name: …………………
CAS Registry Number: ……………………………………………………..
Concentration and content of the narcotic or precursor: .....................
Total content of narcotics and precursors in a smallest packing unit: .....................
………………………………………………………………………………………………………..
5. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
...
...
...
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
7. Number of declaration of eligibility for domestic production of medical devices: ……………………………………….
Declaration of applied standards of class B medical device
Enclosures:
1.
ISO 13485 Certificate
*
...
...
...
Letter of authorization of the owner of the medical device
*
3.
Confirmation of eligibility for warranty
*
4.
Documentation of brief technical description of the medical device in Vietnamese
*
5.
...
...
...
*
6.
Technical documents in Vietnamese enclosed with documents on materials, product safety, manufacturing process and clinical and preclinical research reports including reports on the stability of reagents, calibrators and in vitro control materials.
*
7.
Standard version declared to be applied by the owner of the medical device
*
8.
Certificate of conformity with standards
...
...
...
9.
For a medical device manufactured in Vietnam: result of evaluating chemical, physical and microbiological parameters and other parameters granted by a qualified facility according to the provisions of law on conformity assessment, or Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical devices
*
10.
User manual of the medical device in Vietnamese; for an imported medical device, an original in English, issued by the owner of the medical device, will be enclosed with the user manual in Vietnamese.
*
11.
Template of label on the medical device
*
...
...
...
Certificate of free sale for the imported medical device
*
We hereby declare that:
1. The declared information is accurate and legal according to the regulations. We will wholly be responsible for any falsification and will face penalties according to regulations of law.
2. We ensure the quality of the medical device and trade thereof according to the declaration.
3. Any changes related to the declaration will be updated in accordance with regulations.
Legal representative of the facilitySignature (full name, title)Confirmed by seal or digital signature
...
...
...
___________________
1Geographic name
2Department of Health of the province where the facility is located
3The address written on the business registration certificate
4A medical device, not an in vitro diagnostic medical device
5Specify name of the medical device in Vietnamese in accordance with uses of the medical device, unless its name cannot be translated into Vietnamese.
6Specify the trade name given by the owner of the medical device.
...
...
...
Name of Applicant-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
…1………, day……..month……….year 20……
APPLICATION FOR ISSUANCE OF NUMBERS OF MARKETING AUTHORIZATION OF CLASS C AND CLASS D MEDICAL DEVICES SUBJECT TO NATIONAL TECHNICAL REGULATIONS
To: The Ministry of Health
1. Name of the applicant:……………………………………………………………………………
TIN or number of Licence for representative office establishment: ……………….
...
...
...
Tel: ……………………….Fax:……………………
Email:……………………………………
2. Legal representative of the applicant:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Proposed medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
...
...
...
Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
Packing specification (if any): ……………………………………….
Type of the medical device:…………………………………
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
4. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
...
...
...
5. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
6. Number of declaration of eligibility for domestic production of medical devices: ……………………………………….
7. Effective periods of documents contained in the application3:
- ISO 13485 Certificate:………………………..
- Letter of authorization of the owner of the medical device:……………………………
- Certificate of free sale for the imported medical device: ……………………..
...
...
...
1.
ISO 13485 Certificate
*
2.
Letter of authorization of the owner of the medical device
*
3.
Confirmation of eligibility for warranty
*
...
...
...
Certificate of free sale for the imported medical device
*
5.
Common Submission Dossier Template (CSDT)
*
6.
Certificate of conformity with regulations
*
7.
...
...
...
*
8.
Technical documentation of functions and specifications of the medical device promulgated by its owner
*
9.
Technical documents in Vietnamese enclosed with documents on materials, product safety, product quality control and manufacturing process and clinical and preclinical research reports including reports on the stability of reagents, calibrators and in vitro control materials.
*
10.
User manual of the medical device in Vietnamese; for an imported medical device, an original in English, issued by the owner of the medical device, will be enclosed with the user manual in Vietnamese.
...
...
...
11.
Template of label on the medical device
*
The applicant hereby delares that:
1. The declared information is accurate and legal according to the regulations. The applicant will wholly be responsible for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical device and trade thereof according to the application.
3. Any changes related to the application will be updated in accordance with regulations.
...
...
...
___________________
1Geographic name
2The address written on the business registration certificate
3In case of multiple documents: Specify expiry date of the document whose effective period is shortest. In case of a document whose effective period is not specified, write “indefinite”.
Template No. 03.02
NAME OF APPLICANT-------
...
...
...
No. ………..
…1………, day……..month……….year 20……
APPLICATION FOR ISSUANCE OF MARKETING AUTHORIZATION NUMBERS OF CLASS C AND CLASS D MEDICAL DEVICES WHICH ARE MEASURING INSTRUMENTS SUBJECT TO SAMPLE APPROVAL
To: The Ministry of Health
1. Name of the applicant:……………………………………………………………………………
TIN or number of Licence for representative office establishment: ……………….
Address:…………………2………………………………………………………..
Tel: ……………………….Fax:……………………
...
...
...
2. Legal representative of the applicant:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Proposed medical device
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if any): …………..
Model:…………………………………………………………………………
...
...
...
Packing specification (if any): ……………………………………….
Type of the medical device:…………………………………
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
4. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
5. Information about warranty facility (if any):
...
...
...
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
6. Number of declaration of eligibility for domestic production of medical devices: ……………………………………….
7. Effective periods of documents contained in the application3:
- ISO 13485 Certificate: ………………………..
- Letter of authorization of the owner of the medical device:……………………………
- Certificate of free sale for the imported medical device: ……………………..
Enclosures:
1.
...
...
...
*
2.
Letter of authorization of the owner of the medical device
*
3.
Confirmation of eligibility for warranty
*
4.
Certificate of free sale for the imported medical device
...
...
...
5.
Common Submission Dossier Template (CSDT)
*
6.
Decision on sample approval
*
7.
Documentation of brief technical description of the medical device in Vietnamese
*
...
...
...
Technical documentation of functions and specifications of the medical device promulgated by its owner
*
9.
Technical documents in Vietnamese enclosed with documents on materials, product safety, product quality control and manufacturing process and clinical and preclinical research reports including reports on the stability of reagents, calibrators and in vitro control materials.
*
10.
User manual of the medical device in Vietnamese; for an imported medical device, an original in English, issued by the owner of the medical device, will be enclosed with the user manual in Vietnamese.
*
11.
...
...
...
*
The applicant hereby delares that:
1. The declared information is accurate and legal according to the regulations. The applicant will wholly be responsible for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical device and trade thereof according to the application.
3. Any changes related to the application will be updated in accordance with regulations.
Legal representative of the applicant(Signature (full name, title))Confirmed by seal or digital signature
...
...
...
___________________
1Geographic name
2The address written on the business registration certificate
3In case of multiple documents: Specify expiry date of the document whose effective period is shortest. In case of a document whose effective period is not specified, write “indefinite”.
Template No. 03.03
NAME OF APPLICANT-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
...
...
...
APPLICATION FOR ISSUANCE OF MARKETING AUTHORIZATION NUMBERS OF CLASS C AND CLASS D MEDICAL DEVICES ELIGIBLE FOR QUICK ISSUANCE
To: The Ministry of Health
1. Name of the applicant:……………………………………………………………………………
TIN or number of Licence for representative office establishment: ……………….
Address:………………………2………………………
Tel: ……………………….Fax:……………………
Email:……………………………………
2. Legal representative of the applicant:
...
...
...
ID/passport: ………..date of issue: ……………………. Place of issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Proposed medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if any): …………..
Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
Packing specification (if any): ……………………………………….
...
...
...
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
4. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
5. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
...
...
...
6. Information about the marketing authorization of the medical device:
- Document number:……………………………………
- Name of issuing authority:……………………………………………………………………………
- Date of issue:……….…………….…………..
- Expiry date:................…………………………….………………………....
7. Number of declaration of eligibility for domestic production of medical devices: ……………………………………….
8. Effective periods of documents contained in the application3:
- ISO 13485 Certificate: ………………………..
- Letter of authorization of the owner of the medical device:……………………………
...
...
...
Enclosures:
1.
ISO 13485 Certificate
*
2.
Letter of authorization of the owner of the medical device
*
3.
Confirmation of eligibility for warranty
...
...
...
4.
Certificate of free sale for the imported medical device
*
5.
Common Submission Dossier Template (CSDT)
*
6.
Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical devices
*
...
...
...
Documentation of brief technical description of the medical device in Vietnamese
*
8.
Technical documentation of functions and specifications of the medical device promulgated by its owner
*
9.
Technical documents in Vietnamese enclosed with documents on materials, product safety, product quality control and manufacturing process and clinical and preclinical research reports including reports on the stability of reagents, calibrators and in vitro control materials.
*
10.
...
...
...
*
11.
Template of label on the medical device
*
The applicant hereby delares that:
1. The declared information is accurate and legal according to the regulations. The applicant will wholly be responsible for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical device and trade thereof according to the application.
3. Any changes related to the application will be updated in accordance with regulations.
...
...
...
Legal representative of the applicantSignature (full name, title)Confirmed by seal or digital signature
___________________
1Geographic name
2The address written on the business registration certificate
3In case of multiple documents: Specify expiry date of the document whose effective period is shortest. In case of a document whose effective period is not specified, write “indefinite”.
Template No. 03.04
...
...
...
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
…1………, day……..month……….year 20……
APPLICATION FOR ISSUANCE OF MARKETING AUTHORIZATION NUMBERS OF CLASS C AND CLASS D MEDICAL DEVICES ELIGIBLE FOR EMERGENCY USE AUTHORIZATION
To: The Ministry of Health
1.
Name of the applicant:……………………………………………………………………………
TIN or number of Licence for representative office establishment:
...
...
...
Tel: ……………………….Fax:……………………
Email:……………………………………
2. Legal representative of the applicant:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of issue: ........................
Landline:………………………….Mobile phone: ……………………….
3. Proposed medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
...
...
...
Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
Packing specification (if any): ……………………………………….
Type of the medical device:…………………………………
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
4. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
...
...
...
5. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
6. Information about circulation, emergency use authorization of medical devices (in case of technology transfer or processing where information about the transferred or processed products in circulation has to be provided):
- Document number:……………………………………
- Name of issuing authority:……………………………………………………………………………
- Date of issue:……….…………….…………..
- Expiry date:................…………………………….………………………....
...
...
...
…………………………………………………………………………………………………………
7. Number of declaration of eligibility for domestic production of medical devices: ……………………………………….
8. Effective periods of documents contained in the application3:
- ISO 13485 Certificate: ………………………..
- Letter of authorization of the owner of the medical device:……………………………
- Certificate of free sale for the imported medical device: ……………………..
Enclosures:
1.
ISO 13485 Certificate
...
...
...
2.
Letter of authorization of the owner of the medical device
*
3.
Confirmation of eligibility for warranty
*
4.
Certificate of free sale or licence for emergency use authorization for the imported medical device.
*
...
...
...
Document containing links of the applicant for issuance of marketing authorization numbers
*
6.
Common Submission Dossier Template (CSDT)
*
7.
Technology transfer contract
*
8.
...
...
...
*
9.
Certificate of product quality inspection or assessment
*
10.
Documentation of brief technical description of the medical device in Vietnamese
*
11.
Technical documentation of functions and specifications of the medical device promulgated by its owner
...
...
...
12.
Technical documents in Vietnamese enclosed with documents on materials, product safety, product quality control and manufacturing process and clinical and preclinical research reports including reports on the stability of reagents, calibrators and in vitro control materials.
*
13.
User manual of the medical device in Vietnamese; for an imported medical device, an original in English, issued by the owner of the medical device, will be enclosed with the user manual in Vietnamese.
*
14.
Template of label on the medical device
*
...
...
...
1. The declared information is accurate and legal according to the regulations. The applicant will wholly be responsible for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical device and trade thereof according to the application.
3. Any changes related to the application will be updated in accordance with regulations.
Legal representative of the applicant(Signature (full name, title))Confirmed by seal or digital signature
___________________
...
...
...
2The address written on the business registration certificate
3In case of multiple documents: Specify expiry date of the document whose effective period is shortest. In case of a document whose effective period is not specified, write “indefinite”.
Template No. 03.05
NAME OF APPLICANT-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
…1………, day……..month……….year 20……
...
...
...
To: The Ministry of Health
1. Name of the applicant:……………………………………………………………………………
TIN or number of Licence for representative office establishment: ……………….
Address:………………………2………………………
Tel: ……………………….Fax:……………………
Email:……………………………………
2. Legal representative of the applicant:
Full name:…………………………………………………..………………………….
ID/passport: ………..date of issue: ……………………. Place of issue: ........................
...
...
...
3. Proposed medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if any): …………..
Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
Packing specification (if any): ……………………………………….
Type of the medical device:…………………………………
Uses:………………………………………………………………
...
...
...
Address of manufacturer:……………………………………………………………………………
4. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
5. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
6. Number of declaration of eligibility for domestic production of medical devices: ……………………………………….
...
...
...
- ISO 13485 Certificate: ………………………..
- Letter of authorization of the owner of the medical device:……………………………
- Certificate of free sale for the imported medical device: ……………………..
Enclosures:
1.
ISO 13485 Certificate
*
2.
Letter of authorization of the owner of the medical device
...
...
...
3.
Confirmation of eligibility for warranty
*
4.
Certificate of free sale for the imported medical device
*
5.
Common Submission Dossier Template (CSDT)
*
...
...
...
Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical devices
*
7.
Testing form for composition and content of substances with antibacterial activity; assessment form for bio-efficacy of products for chemicals and preparations serving the only purpose of sterilization.
*
8.
Documentation of brief technical description of the medical device in Vietnamese
*
9.
...
...
...
*
10.
Technical documents in Vietnamese enclosed with documents on materials, product safety, product quality control and manufacturing process and clinical and preclinical research reports including reports on the stability of reagents, calibrators and in vitro control materials.
*
11.
User manual of the medical device in Vietnamese; for an imported medical device, an original in English, issued by the owner of the medical device, will be enclosed with the user manual in Vietnamese.
*
12.
Template of label on the medical device
...
...
...
The applicant hereby delares that:
1. The declared information is accurate and legal according to the regulations. The applicant will wholly be responsible for any falsification and will face penalties according to regulations of law.
2. The applicant ensures the quality of the medical device and trade thereof according to the application.
3. Any changes related to the application will be updated in accordance with regulations.
Legal representative of the applicant(Signature (full name, title))Confirmed by seal or digital signature
...
...
...
1Geographic name
2The address written on the business registration certificate
3In case of multiple documents: Specify expiry date of the document whose effective period is shortest. In case of a document whose effective period is not specified, write “indefinite”.
Template No. 05.A
Application for medical device import licence serving the implementation of regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP
Name of importer-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ……../……1
...
...
...
Application for import licence
To: The Ministry of Health
Importer:
Address:
TIN:
Tel: Fax:
Legal representative:
Landline: Mobile phone:
...
...
...
Landline: Mobile phone:
We hereby apply for the licence to import the following medical devices:
No.
Name of medical device
Model
Manufacturer, country of manufacture
Manufacturer, country of product owner
Distributor, country of distribution(if any)
Year of production
...
...
...
1. Purpose of import:
2. Time limit of certificate of free sale:
3. Time limit of ISO certificate:
...
...
...
5. We hereby declare that:
- We are responsible for the consistency of the quality, model, quantity and brand-newness of the imported medical devices with the application.
- We are responsible for warranty on medical devices and provision of chemicals, materials and spare parts during the use of such medical devices.
- We have qualified personnel in charge of effectiveness and safety of medical devices for users and environment, and ensure that the quality of the imported medical devices is not affected during transport and in our facilities. We fully comply with regulations on goods labeling.
- The imported medical devices are used in accordance with the application. We will facilitate inspection by competent authorities.
We will be responsible before law for breach of the above-mentioned commitments.
Importer(Signature, full name and seal)
...
...
...
___________________
1Abbreviation of the importer
2Name of province or city where the importer is located
Template No. 05.B
Order for import of biological products for in vitro diagnostic test serving the implementation of the regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP
Name of importer-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
...
...
...
Order for import
To: The Ministry of Health
(Name of importer) herein requests the Department of Medical Equipment and Works – of the Ministry of Health to consider granting an approval in order that (the importer) may import the following biological products for in vitro diagnostic test which are not registered:
Name of biological product for in vitro diagnostic test, composition, content, dosage form, packing specification
Unit
Import quantity
Date of production / expiry date
...
...
...
Name and country of manufacturer
Name and country of supplier
Name of entrustor(if any) *
...
...
...
* If the import is not entrusted, specify “No entrustment”
…………., day….month………. yearDirector of the importer(signature, seal)
APPENDIX IV
Template of MEDICAL DEVICE application for DECLARATION, CERTIFICATE, IMPORT LICENCE (enclosed with Circular No. 10/2023/TT-BYT dated May 11, 2023 of the Minister of Health)
Template No. 02.01
...
...
...
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. 05
Medical device import licence serving the implementation of regulations in Clause 2 Article 48 of Decree No. 98/2021/ND-CP and Clause 12 Article 1 of Decree No. 07/2023/ND-CP
Template No. 05.A
Import licence serving the implementation of regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP
Template No. 05.B
...
...
...
Template No. 07
Certificate of free sale for the medical devices
Template No. 02.01
….1….-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
Information
Application for declaration of applied standards of class A medical devices
...
...
...
Declaration date:…………
1. Name of declarant: ......................................................................................
2. Address:…………………………………………………………………………..
3. Document number of the declarant:………………………………… Date:…………………..
4. Class A medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if any): …………..
Model:…………………………………………………………………………
...
...
...
Packing specification (if any): ……………………………………….
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
Applied standard: ....................................................
5. For medical device that contains narcotic or precursor (if any):
Name of the narcotic or precursor: …………..Scientific name: …………………
CAS Registry Number: ……………………………………………………..
Concentration and content of the narcotic or precursor: .....................
...
...
...
6. Information about the owner of the medical device:
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
7. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
8. Number of declaration of eligibility for domestic production of medical devices: ……………………………………….
9. Enclosures:
...
...
...
Application form
*
2.
ISO 13485 Certificate
*
3.
Letter of authorization of the owner of the medical device
*
4.
...
...
...
*
5.
Standard version declared to be applied by the owner of the medical device
*
6.
Certificate of conformity with standards
*
7.
For a medical device manufactured in Vietnam: adding result of evaluating chemical, physical and microbiological parameters and other parameters granted by a qualified facility according to the provisions of law on conformity assessment, or Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical devices
...
...
...
8.
User manual of the medical device in Vietnamese; for an imported medical device, an original in English, issued by the owner of the medical device, will be enclosed with the user manual in Vietnamese
*
9.
Template of label on the medical device
*
10.
Certificate of free sale for the imported medical device
*
...
...
...
1Department of Health of the province where the applicant is located
Template No. 02.02
...1…-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
INFORMATION
Application for declaration of applied standards of class B medical devices
Declaration number:…………
...
...
...
1. Name of the declarant:……………………………………………………………………………
2. Address:………………………………………………
3. Document number of the declarant:…………………………………Date:…………………..
4. Class B medical device:
Name of the medical device:…………………………………
Trade name (if any):…………………..…………………………………….
Global Medical Device Nomenclature - GMDN code (if any): …………..
Model:…………………………………………………………………………
Product code (if any): ……………………………………………………..
...
...
...
Uses:………………………………………………………………
Name of manufacturer:……………………………………………………………………………
Address of manufacturer:……………………………………………………………………………
Applied standard: ....................................................
5. For medical device that contains narcotic or precursor (if any):
Name of the narcotic or precursor: …………..Scientific name: …………………
CAS Registry Number: ……………………………………………………..
Concentration, content: .....................
Total content of narcotics and precursors in a smallest packing unit: .....................
...
...
...
Owner's name:…………………………………………………………………………
Owner's address:…………………………………………………………………………
7. Information about warranty facility (if any):
Name of the facility:……………………………………………………………………………
Address:………………………………………………
Landline:………………………….Mobile phone: ……………………….
8. Number of declaration of eligibility for domestic production of medical devices: ……………………………………….
9. Enclosures:
1.
...
...
...
*
2.
ISO 13485 Certificate
*
3.
Letter of authorization of the owner of the medical device
*
4.
Confirmation of eligibility for warranty
...
...
...
5
Standard version declared to be applied by the owner of the medical device
*
6.
Certificate of conformity with standards
*
7.
For a medical device manufactured in Vietnam: adding result of evaluating chemical, physical and microbiological parameters and other parameters granted by a qualified facility according to the provisions of law on conformity assessment, or Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical devices
*
...
...
...
User manual of the medical device in Vietnamese; for an imported medical device, an original in English, issued by the owner of the medical device, will be enclosed with the user manual in Vietnamese
*
9.
Template of label on the medical device
*
10.
Certificate of free sale for the imported medical device
*
___________________
...
...
...
Template No. 03
MINISTRY OF HEALTH OF VIETNAM-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
Hanoi, …….(date)…….
Certificate of marketing authorization of class C and class D medical devices
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices;
...
...
...
The Ministry of Health hereby grants a certificate of marketing authorization to the following brand-new medical device:
1. Name of medical device:
2. Trade name (if any):
3. Global Medical Device Nomenclature - GMDN code (if any):
4. Type of medical device:
5. Name and address of owner of medical device:
6. Name and address of holder of marketing authorization number:
7. Uses; name and address of warranty facility: See attached annex.
8. Detail on medical device (model; product code; packing specification; name of manufacturer; address of manufacturer and country of production): See attached annex.
...
...
...
Authority and position of signer(signature of competent person, seal of issuer)Full name
Page……/……
attached annex
1. Uses:
2. Name, address of warranty facility:
3. Details on medical device:
...
...
...
Name of medical device
Model
Product code (if any)
Packing specification (if any)
Name of manufacturer
Address of manufacturer
Country of production
...
...
...
...
...
...
...
...
...
Page……/……
Template No. 05
Template of Medical device import licence
Serving the implementation of the regulations in Clause 2 Article 48 of Decree No. 98/2021/ND-CP and Clause 12 Article 1 of Decree No. 07/2023/ND-CP
MINISTRY OF HEALTH OF VIETNAM-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
...
...
...
To: ……………………………………………………
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March 03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices.
Considering the request in Official Dispatch No. …………. dated…………… on ………….. The Ministry of Health hereby comes to an agreement with the request of (the applicant) on import of consignment of brand-new medical devices. To be specific:
No.
Name of medical device
Model/ Product code
Manufacturer, country of manufacture
...
...
...
Distributor, country of distribution
(if any)
Quantity
Unit
...
...
...
...
...
...
…….1……… shall be responsible for site inspection of goods quality before receipt, cooperate with Customs authority in solving import-related issues in accordance with regulations, be responsible for quality and safety of such goods, and use for intended puposes.
Authority and position of signer(signature of competent person, seal of issuer)Full name
___________________
1Name of importer
Template No. 05.A
TEMPLATE OF MEDICAL DEVICE IMPORT LICENCE
...
...
...
MINISTRY OF HEALTH OF VIETNAM-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No.issuing medical device import licence
Hanoi,….date..….
To: ……….. Name of importer…………
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Pursuant to Decree No. 07/2023/ND-CP dated March 03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices.
Considering the request in Official Dispatch No. …………. dated……………of the importer on import of medical devices. The Ministry of Health hereby grants a licence to import the following brand-new medical devices:
...
...
...
Name of the medical device
Model
Manufacturer, country of manufacture
Manufacturer, country of product owner
Distributor, country of distribution(if any)
...
...
...
The importer must comply with the applicable regulations on import of medical devices. The importer must comply with regulations on labeling, and take responsibility for quantity, value and quality of the imported medical devices in accordance with regulations of law.
This document comes into force from December 31, 2024.
AUTHORITY AND POSITION OF SIGNER(signature of competent person, seal of issuer)Full name
Template No. 05.B
Licence to import biological products for in vitro diagnostic test
...
...
...
MINISTRY OF HEALTH OF VIETNAM-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No.importing biological products for in vitro diagnostic test
Hanoi,….date..….
To: Importer ………….
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March 03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices.
Considering the request in Order No. ………….……………of the importer on import. The Ministry of Health hereby grants a licence to import the following brand-new biological products for in vitro diagnostic test:
...
...
...
Unit
Date of production / expiry date
Use
Name and country of manufacturer
Name and country of supplier
Name of entrustor(if any)
...
...
...
The importer must comply with the applicable regulations on import of biological products for in vitro diagnostic test. The importer must comply with regulations on labeling, and concurrently take responsibility for quantity, value and quality of the imported biological products in accordance with regulations of law.
This document comes into force from December 31, 2024.
AUTHORITY AND POSITION OF SIGNER(signature of competent person, seal of issuer)Full name
...
...
...
VIETNAM MINISTRY OF HEALTH-------
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom - Happiness
Hanoi, date... month... year ...
CERTIFICATE OF FREE SALE
Certificate No: ……………… /CFS/BYT-TB-CT
Product Owner:
Address:
...
...
...
This is to certify that the above product(s) complies with the Medical Device regulations of Vietnam and is (are) allowed to be sold in Vietnam.
This certificate is issued according to Decision No: ………………
AUTHORITY AND POSITION OF SIGNER(signature of competent person, seal of issuer)Full name
Page……/……
Attached Annex
Certificate of Free sale No: …………… CFS/BYT-TB-CT
...
...
...
1.
Name of Manufacturer:
Address:
2.
Name of Manufacturer:
Address:
II. Name of Product(s):
1.
Product name:
...
...
...
Product code:
Market Authorization number in Vietnam:
Name of Manufacturer
2.
Product name:
Model:
Product code:
Market Authorization number in Vietnam:
Name of Manufacturer:
...
...
...
Page .........../........
APPENDIX VI.A
Letter of authorization Template 1 serving the issuance of medical device import licence according to regulations in Clause 18 Article 1 of Decree No. 07/2023/ND-CP (enclosed with Circular No. 10/2023/TT-BYT dated May 11, 2023 of the Ministry of Health)
………2……….
Day ……month……..year
LETTER OF AUTHORISATION
To: …………………………
We, (Name and address of product owner), as the legal manufacturer (product owner) do hereby authorize (Name and address of the importer) to apply for import licence, import the following medical devices:
...
...
...
We commit to provide and support all information concerning product information, product quality upon request by Vietnam Ministry of Health (Department of Medical Equipment and Constructions) for medical devices mentioned above.
This authorization letter is valid until: ………. date (dd/mm/yy)
Legitimate representative of legal manufacturer (product owner)
Signature
(Full name and title)
___________________
1Written in both Vietnamese and English (except for medical devices produced domestically), and other languages (if any).
2Information about the owner of the medical device (the product owner)
...
...
...
APPENDIX VIII
TEMPLATES OF TECHNICAL DOCUMENTS FOR MEDICAL DEVICES (enclosed with Circular No. 10/2023/TT-BYT dated May 11, 2023 of the Minister of Health)
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. 04
Documentation of brief technical description of imported medical devices serving the issuance of marketing authorization numbers
Template No. 06
Technical description of models of imported medical devices serving the issuance of import licences
Template No. 04
...
...
...
Name and address of facility registering for circulation of medical device
Day………month………year 20………..
No
Heading
Brief description
1
Product description of the medical device
1.1
Prescription of the medical device
...
...
...
1.2
Catalog of parts and accessories
List of parts and accessories of the medical device
1.3
Purposes/Indications
List of purposes/indications of the medical device
1.4
Instructions for use
Brief instructions for use of the medical device as prescribed in the Instruction sheet or Information sheet of the medical device
...
...
...
Contraindication
Information on the contraindication – means that cases in which the use of the medical device must not be used for reasons of patient safety, for example due to the patient's medical history, physiological characteristics, etc., is in accordance with the approved content in the country in which marketing authorization is granted and is stated on the label of the medical device
1.6
Warnings and cautions
Warnings and cautions when using the medical device, including preventive measures to protect patients from risks caused by the use of the medical device. They can be warnings about adverse effects or misuse and precautions
1.7
Adverse effects
Adverse effects related to the use of the medical device is recorded through clinical tests and after-sales service which have been previously performed for the medical device
2
...
...
...
Information on the countries in which the certificate of marketing authorization of the product is granted, or the first country in which the certificate of marketing authorization of the medical device is granted
3
Indications that have been registered in other countries (if any)
List of countries in which certificates of marketing authorization attached with the indications approved in these countries are granted; dates of issue of these certificates
4
Notable information about the safety/operation of the medical device
- Information on the number of reports on adverse effects related to the use of the medical device; measures for recall/adjustment of after-sales services implemented at the request of regulatory authorities of some countries;
- Information about the following components of the medical device is mandatory:
● Human or animal cells or tissues or their derivatives intended for use in a non-viable form – e.g. artificial heart valves from pig or cat intestines, etc.;
...
...
...
5
Reports on clinical assessment of class C and D medical devices which are not in vitro diagnostic medical devices
5.1
Clinical assessment
Reports on clinical assessment of the owners of the medical devices in Vietnamese or English
5.2
References of the clinical assessment
List of references (if any)
We certify that the above information is true. We will be responsible before law for the above-mentioned information.
...
...
...
Legal representative of the facilitySignature (full name, title)Confirmed by seal or signature
Template No. 06
Template of TECHNICAL DESCRIPTION OF models of IMPORTED MEDICAL DEVICES
Name of importer
SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom – Happiness---------------
No. ………..
…….(location), day…… month……year…….
...
...
...
TECHNICAL DESCRIPTION OF MODELS OF IMPORTED MEDICAL DEVICES
No
Heading
Brief description
1
Description of model of medical device
1.1
Prescription of the medical device
Brief prescription of operating principles and features and technical parameters of the medical device; specify that if the device uses new technologies, a description of such new technologies (e.g. nanotechnology) should be provided.
...
...
...
Catalog of parts and accessories (including added chemicals)
List of parts and accessories of the medical device; As for medical devices for which chemicals and special reagents are provided, list of such chemicals and special reagents is required.
1.3
Purposes/ Indications
List of purposes/indications intended to be written on the label of the imported medical device
1.4
Instructions for use
Brief instructions for use of the medical device is in accordance with the instructions for use or information sheet of the imported medical device
1.5
...
...
...
Information on the contraindication – means that cases in which the use of the medical device must not be used for reasons of patient safety, for example due to the patient's medical history, physiological characteristics, etc., is in accordance with the approved content in the country of production and is stated on the label of the imported medical device
1.6
Warnings and cautions
Warnings and cautions when using the medical device, including preventive measures to protect patients from risks caused by the use of the medical device. They can be warnings about adverse effects or misuse and precautions
1.7
Adverse effects
Adverse effects related to the use of the medical device is recorded through clinical tests and after-sales service which have been previously performed for the imported medical device
2
Information of the product circulated in countries (if any)
...
...
...
3
Indications that have been registered in other countries (if any)
List of countries in which certificates of marketing authorization attached with the indications approved in these countries are granted; dates of issue of these certificates
4
Notable information about the safety/operation of the medical device:
- (Information on the number of reports on adverse effects related to the use of the medical device; measures for recall/adjustment of after-sales services implemented at the request of regulatory authorities of some countries)
- ( Information about the following components of the medical device is mandatory:
● Human or animal cells or tissues or their derivatives intended for use in a non-viable form – e.g. artificial heart valves from pig or cat intestines, etc.;
● Cells, tissues and/or derivatives of microbial or recombinant origin – e.g. hyaluronic acid-based dermal fillers obtained by bacterial fermentation, etc.; Contain allergic or ionizing ingredients – e.g. X-ray; or non-ionizing - E.g. laser, ultrasound, etc.
...
...
...
Legal representative of the facilitySignature (full name, title)Confirmed by seal or signature
| Số hiệu | 10/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y tế |
| Ngày ban hành | 11/05/2023 |
| Người ký | Đỗ Xuân Tuyên |
| Ngày hiệu lực | |
| Tình trạng |
Bạn chưa có tài khoản? Hãy Đăng ký
| Số hiệu | 10/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y tế |
| Ngày ban hành | 11/05/2023 |
| Người ký | Đỗ Xuân Tuyên |
| Ngày hiệu lực | |
| Tình trạng |