Circular No. 44/2025/TT-BYT on providing regulations on the delegation of authority to implement some tasks and handle some medical device-related administrative procedures under the jurisdiction of the Ministry of Health and regulations on templates of documents and reports on the management of medical devices

 

CIRCULAR

Providing regulations on the delegation of authority to implement some tasks and handle some medical device-related administrative procedures under the jurisdiction of the Ministry of Health and regulations on templates of documents and reports on the management of medical devices

Pursuant to Law on Government Organization No. 63/2025/QH15;

Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree NO. 04/2025/ND-CP;

Pursuant to Decree No. 217/2025/ND-CP dated August 05, 2025 of the Government on specialized inspection;

Pursuant to Decree No. 42/2025/ND-CP dated February 27, 02 of the Government on function, tasks, powers and organizational structures of the Ministry of Health of Vietnam;

At the request of the Director of the Infrastructure and Medical Device Administration (IMDA),

The Minister of Health hereby promulgates a Circular providing regulations on the delegation of authority to implement some tasks and handle some medical device-related administrative procedures under the jurisdiction of the Ministry of Health and regulations on templates of documents and reports on the management of medical devices.

Article 1. Scope

This Circular provides for:

1. The delegation of implementation of some tasks and handling of some medical device-related administrative procedures under the jurisdiction of the Ministry of Health.

2. Templates of documents and reports on management of medical devices as specified in clause 12 Article 70 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

Article 2. Delegation of authority to implement some tasks and handle some medical device-related administrative procedures under the jurisdiction of the Ministry of Health to the IMDA

1. Issuance of new marketing authorization numbers of class C and class D medical devices as specified in clause 32, Article 32a of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

2. Inspection after issuance of marketing authorization numbers of class C and class D medical devices as specified in clause 3 and clause 4 clause 32 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

3. Suspension of circulation of  batches of medical devices, termination of suspension of circulation of batches of medical devices as specified in clause 3, Article 34 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

4. Recall of batches of medical devices as specified in clause 4 Article 34 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

5. Issuance of documents on the permission or prohibition of continued circulation of medical devices in accordance with the provisions of Article 37 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

6. Recall of numbers of marketing authorization of medical devices as specified in Article 39 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

7. Issuance of medical device import license as specified in Article 48 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

8. Issuance, renewal and revocation of certificates of free sale of medical devices as specified in Article 50 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

9. Issuance, supplementation and revocation of certificates of registration of inspection of medical devices as specified in Article 56 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

10. Decision on the handling of medical devices that fail to meet requirements for inspection as specified in Article 58 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

11. Specialized inspection for organizations and individuals engaged in the classification of medical devices; manufacturing, circulation, trading, exporting, importing and supply of medical device services; information and advertising of medical devices; management and use of medical devices at medical facilities in accordance with the provisions of Clause 1, Article 6 of Decree No. 217/2025/ND-CP.

Article 3. Templates of documents and reports on management of medical devices

Templates of documents and reports serving the management of medical devices as specified in clause 12 Article 70 of Decree No. 98/2021/ND-CP amended by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP are enclosed herewith:

1. Appendix I: Written declaration of, disclosure of, statement of, notification of or request for issuance of marketing authorization number, import license and certificate of free sale.

2. Appendix II: Personnel list.

3. Appendix III: Information on application for declaration, certificate, import license.

4. Appendix IV: Written commitment and request for continued circulation of medical devices.

5. Appendix V: Letter of authorization.

6. Appendix VI: Confirmation of eligibility for warranty.

7. Appendix VII: Technical document for medical devices.

8. Appendix VIII: Report on receipt, dispatch, inventory, use of medical devices, production materials, EQA reagents that contain narcotics/precursors.

Article 4. Entry into force

1. This Circular comes into force from November 22, 2025.

2. Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health shall be invalid from the effective date of this Circular.

Article 5. Transitional provision

1. Regarding applications that have been submitted to regulatory authorities before the effective date of this Circular and are made using the templates specified in Circular No. 19/2021/TT-BYT amended by Circular No. 10/2023/TT-BYT: If the such documents and reports are invalid or there are requests for amendments, organizations and individuals must use the templates enclosed herewith when updating or amending such documents and reports.

2. For Letters of authorization and Confirmations of eligibility for warranty of medical devices that are signed by the medical device owner for issuance using the templates in Circular No. 19/2021/TT-BYT amended by Circular No. 10/2023/TT-BYT before the effective date of this Circular and are still valid, they may be used continuously.

Article 6. Organization of implementation

Chief of the Ministry Office, Director of Department of Personnel and Organization, Director of Department of Legal Affairs, Director of IMDA, agencies, organizations and individuals are responsible for the implementation of this Circular.

Any difficulties arising during the implementation of this Circular should be reported to the Ministry of Health (via the IMDA) for timely consideration and handling./.

 

 

APPENDIX I

TEMPLATES OF DECLARATION OF, DISCLOSURE OF, STATEMENT OF, NOTIFICATION OF AND REQUEST FOR ISSUANCE OF NUMBERS OF MARKETING AUTHORIZATION, IMPORT LICENSES AND CERTIFICATES OF FREE SALE
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the Minister of Health)

Template No. 01

 

DISCLOSURE

OF ELIGIBILITY FOR PRODUCTION OF MEDICAL DEVICES

To: ………….²……………….

1. Name of manufacturing facility:

TIN: …………………………………………………………………..

Address of the head office: …….. ³ ………………………………………………………

Address of the facility: ………………….. ⁴……………………………………………

Tel: ………………………….. ………….. Fax: ………………………..

Email: ………………………………… Website (if any): …………..

2. Legal representative of the manufacturing facility:

Full name: ……………………………………………………………………

ID card number/passport number: ………..date of issue: ……………………. Place of issue: ……………………

Landline: ………………………. Mobile phone: ……………………

3. Medical devices produced by the manufacturing facility:

Declaration of eligibility for production of medical devices

Enclosures:

We hereby commit 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 fulfillment and maintenance of requirements declared during the process of operation.

3. Any changes related to the application for declaration of eligibility for production of medical devices will be updated as per regulations.

 

__________________________

¹ Geographic name

² Department of Health of the province/central-affiliated city where the manufacturing facility is located

³ The address written on the business registration certificate

⁴ If it coincides with the registered business address, state “at the headquarters”

Template No. 02

 

DECLARATION

OF APPLIED STANDARDS OF CLASS A MEDICAL DEVICES

To: ………….²……………….

1. Name of the declaring facility: ……………………………………………………………………

TIN or number of Licence for representative office establishment: ……………..

Address: ……³……… …………………………………………………………………….

Landline: .. ……………………………….. Fax:  .. ……………………………..

Email: …………………………………….……… ………………………………………..

2. Legal representative of the facility:

Full name: ……………………………………………………………………………………

ID card number/Passport number: ……. Date of issue: ……… Place of issue:  …………………….

Landline: ………………………. Mobile phone: ………………………

3. Class A medical device:

Common medical devices⁴: □ or in vitro diagnostic medical devices: □

Name of 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 manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: …………………………………………………………………..

Applied standards: ……………………………………………………………………..

4. For medical device that contains narcotic or precursor:

Name of narcotic/ precursor: …………………. Scientific name: ……………

CAS Registry Number (CAS RN): ……………………………………………………………………….

Concentration and content of the narcotic or precursor: ……………………………………..

Total content of narcotics or precursors in a smallest packing unit:

………………………………………………………………………………………………………….

5. Information about the owner of the medical device:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ……………………………………………………………………….

6. Information about warranty facility (if any):

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 A medical devices

Enclosures:

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. The quality of the medical device will be ensured and the medical device will be circulated in accordance with the declaration.

3. Any changes related to the declaration will be updated in accordance with regulations.

 

__________________________

¹ Geographic name

² Department of Health of the province/central-affiliated city where the facility is located

³ The address written on the business registration certificate

⁴ A non-IVD medical device:

⁵ Name of the medical device in Vietnamese written according to the intended use of the medical device, except in cases where Vietnamese translation is not possible.

⁶  Trade name given by the medical device owner.

Template No. 03

 

DECLARATION

OF APPLIED STANDARDS OF CLASS B MEDICAL DEVICES

To: ………….²……………….

1. Name of the declaring facility: ……………………………………………………………………

TIN or number of Licence for representative office establishment: ……………..

Address: ……³……… …………………………………………………………………….

Landline: .. ……………………………….. Fax:  .. ……………………………..

Email: …………………………………….……… ………………………………………..

2. Legal representative of the facility:

Full name: ……………………………………………………………………………………

ID card number/Passport number: ……. Date of issue: ……… Place of issue:  …………………….

Landline: ………………………. Mobile phone: ………………………

3. Class B medical device:

Common medical devices⁴: □ or in vitro diagnostic medical devices: □

Name of medical device ⁵: ………………………………………………………………………….

Trade name⁶ (if any): ………………………………………………………………

Global Medical Device Nomenclature – GMDN code (if any):  ……………..

Model: ………………………………………………………………………………….

Product code (if any): ………………………………………………………………….

Packing specification (if any): …………………………………………………………..

Uses: ………………………………………………………………………..

Name of manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: …………………………………………………………………..

Applied standards: ……………………………………………………………………..

4. For medical device that contains narcotic or precursor:

Name of narcotic/ precursor: ……………Scientific name: ………..……

CAS Registry Number (CAS RN): ……………………………………………………………………….

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:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ……………………………………………………………………….

6. Information about warranty facility (if any):

Name of the facility: ……………………………………………………………………………………

Address: ……………………………………………………………………………………….

Landline: ………………….. Mobile phone: ……………………..

7. Number of declaration of eligibility for domestic production of medical device:…

……………………………………………………………………………………………….

Declaration of applied standards of class B medical devices

Enclosures:

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. The quality of the medical device will be ensured and the medical device will be circulated in accordance with the declaration.

3. Any changes related to the declaration will be updated in accordance with regulations.

 

__________________________

¹ Geographic name

² Department of Health of the province/central-affiliated city where the facility is located

³ The address written on the business registration certificate

⁴ A non-IVD medical device:

⁵ Name of the medical device in Vietnamese written according to the intended use of the medical device, except in cases where Vietnamese translation is not possible.

⁶  Trade name given by the medical device owner.

Template No. 04

 

WRITTEN REQUEST

for issuance of new marketing authorization numbers of class C and class D medical devices subject to national technical regulations

To: Infrastructure and Medical Device Administration (IMDA)

1. Name of the registering facility: ……………………………………………………………………

TIN or number of Licence for representative office establishment: ……………..

Address:………. ²……….. ………………………………………………………………………

Tel: ………………………………………Fax: …………………………………

Email: ……………………………………. ………………………………………………….

2. Legal representative of the facility:

Full name: ……………………………………………………………………………………

ID card number/Passport number: ………… Date of issue: ………… Place of issue:  …………………

Landline: ………………………. Mobile phone: ………………………

3. Medical device requiring marketing authorization:

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 medical device: ………………………………………………………………………….

Uses: ………………………………………………………………………..

Name of manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: …………………………………………………………………..

4. Information about the owner of the medical device:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ……………………………………………………………………….

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 device: ..

……………………………………………………………………………………………………..

7. Effective periods of documents contained in the application ³:

– ISO 13485 Certificate: …………

– Letter of authorization of the medical device owner. ……………………………..

– Certificate of free sale for the imported medical device: …………………………

Enclosures:

We hereby delares 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. The quality of the medical device will be ensured and the medical device will be circulated in accordance with the application.

3. Any changes related to the application will be updated in accordance with regulations.

 

__________________________

¹ Geographic name

² The address written on the business registration certificate

³ In 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

 

WRITTEN REQUEST

for issuance of new marketing authorization numbers of medical devices of class C and class D medical devices that are measuring instruments whose samples require approval as prescribed by the law on measurement

To: Infrastructure and Medical Device Administration (IMDA)

1. Name of the registering facility: ……………………………………………………………………

TIN or number of Licence for representative office establishment: ……………..

Address:…………²………………………………………………………………..

Tel: ……………………………… ………Fax: …………………………………

Email: ……………………………………. ………………………………………………….

2. Legal representative of the facility:

Full name: ……………………………………………………………………………………

ID card number/Passport number: ……. Date of issue: …… Place of issue:  …………………………….

Landline: ………………….. Mobile phone: ………………………

3. Medical device requiring marketing authorization:

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 medical device ………………………………………………………………………….

Uses: ………………………………………………………………………..

Name of manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: ………………………………………………………………….

4. Information about the owner of the medical device:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ………………………………………………………………………

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 device: ..

7. Effective periods of documents contained in the application ³:

– ISO 13485 Certificate: …………

– Letter of authorization of the medical device owner: ……………………………..

– Certificate of free sale for the imported medical device: …………………………

Enclosures:

We hereby delares 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. The quality of the medical device will be ensured and the medical device will be circulated in accordance with the application.

3. Any changes related to the application will be updated in accordance with regulations.

 

__________________________

¹ Geographic name

² The address written on the business registration certificate

³ In 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. 06

 

WRITTEN REQUEST

for issuance of new marketing authorization numbers of class C and class D medical devices eligible for quick issuance

To: Infrastructure and Medical Device Administration (IMDA)

1. Name of the registering facility: … ………………………………………………………………..

TIN or number of Licence for representative office establishment: ……………..

Address:……²………….. …………………………………………………

Tel: ……………………………… ………Fax: …………………………………

Email: ……………………………………. …………………………………………

2. Legal representative of the facility:

Full name: ……………………………………………………………………………………

ID card number/Passport number: ……. Date of issue: …… Place of issue:  …………………………….

Landline: ………………….. Mobile phone: ………………………

3. Medical device requiring marketing authorization:

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 medical device ………………………………………………………………………….

Uses: ………………………………………………………………………..

Name of manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: ………………………………………………………………….

4. Information about the owner of the medical device:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ………………………………………………………………………

5. Information about warranty facility (if any):

Name of the facility: …………………………………………………………………………………..

Address: ……………………………………………………………………………………….

Landline: ………………….. Mobile phone: ………………………

6. Information about the circulation of the medical device:

– Number of document: …………………………………………………………………………

– Name of the issuing organization: …………………………………………………………………………

– Date of issue: ………………………………………………………………………………….

– Expiry date: ………………………………………………………………………

7. Number of declaration of eligibility for domestic production of medical device: ..

………………………………………………………………………………………………………

8. Effective periods of documents contained in the application³:

– ISO 13485 Certificate: …………

– Letter of authorization of the medical device owner: ……………………………..

– Certificate of free sale for the imported medical device: …………………………

Enclosures:

We hereby delares 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. The quality of the medical device will be ensured and the medical device will be circulated in accordance with the application.

3. Any changes related to the application will be updated in accordance with regulations.

 

__________________________

¹ Geographic name

² The address written on the business registration certificate

³ In 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. 07

 

WRITTEN REQUEST

for issuance of new marketing authorization numbers of class C and class D medical devices eligible for emergency use authorization

To: Infrastructure and Medical Device Administration (IMDA)

1. Name of the registering facility: ……………………………………………………………………

TIN or number of Licence for representative office establishment: ……………..

Address:………. ²……….. ……………………………………………………………….

Tel: ……………………………… ………Fax: …………………………………

Email: ……………………………………. …… …………………………………………..

2. Legal representative of the facility:

Full name: ……………………………………………………………………………………

ID card number/Passport number: ……. Date of issue: …… Place of issue:  …………………………….

Landline: ………………….. Mobile phone: ……………………..

3. Medical device requiring marketing authorization:

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 medical device …………………………………………………………………………..

Uses: ………………………………………………………………………..

Name of manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: ………………………………………………………………….

4. Information about the owner of the medical device:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ………………………………………………………………………

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):

– Number of document: …………………………………………………………………………

– Name of the issuing organization: …………………………………………………………………………

– Date of issue: ………………………………………………………………………………….

– Expiry date: ………………………………………………………………………

– Links to the documents about the circulation and permission for use of the medical device:  …..

7. Number of declaration of eligibility for domestic production of medical device:

……………………………………………………………………………………………………..

8. Effective periods of documents contained in the application³:

– ISO 13485 Certificate: …………

– Letter of authorization of the medical device owner: ……………………………..

– Certificate of free sale for the imported medical device: …………………………

Enclosures:

We hereby delares 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. The quality of the medical device will be ensured and the medical device will be circulated in accordance with the application.

3. Any changes related to the application will be updated in accordance with regulations.

 

__________________________

¹ Geographic name

² The address written on the business registration certificate

³ In 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. 08

 

WRITTEN REQUEST

for issuance of new marketing authorization numbers of other class C and class D medical devices

To: Infrastructure and Medical Device Administration (IMDA)

1. Name of the registering facility: …. ……………………………………………………………….

TIN or number of Licence for representative office establishment: ……………..

Address:………. ²……….. ……………………………………………………………….

Tel: ……………………………… ………Fax: …………………………………

Email: ……………………………………. …… …………………………………………..

2. Legal representative of the facility:

Full name: ……………………………………………………………………………………

ID card number/Passport number: ……. Date of issue: …… Place of issue:  …………………………….

Landline: ………………….. Mobile phone: ………………………

3. Medical device requiring marketing authorization:

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 medical device ………………………………………………………………………….

Uses: ………………………………………………………………………..

Name of manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: ………………………………………………………………….

4. Information about the owner of the medical device:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ………………………………………………………………………

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 device:

……………………………………………………………………………………………………………..

7. Effective periods of documents contained in the application³:

– ISO 13485 Certificate: …………

– Letter of authorization of the medical device owner: ……………………………..

– Certificate of free sale for the imported medical device: …………………………

Enclosures:

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. The quality of the medical device will be ensured and the medical device will be circulated in accordance with the application.

3. Any changes related to the application will be updated in accordance with regulations.

 

__________________________

¹ Geographic name

² The address written on the business registration certificate

³ In 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. 09

 

DECLARATION

of eligibility for trading of class b, class c and class d medical devices

To: ………….²……………….

1. Name of the facility: …………………………………………………………………………………………

TIN: ………………………………………………………………………

Address:………³………………………………………

Transaction office (if any): …………………………………………………..

2. Legal representative of the facility:

Full name: ………………………………………………………………………..

ID card number/Passport number: ……. Date of issue: ……… Place of issue:  ……………………….

Landline: …………………………. Mobile phone: ……………………

3. Technical staff of the business facility⁴:

Full name: ………………………………………………………………………..

ID card number/Passport number: ……. Date of issue: ……… Place of issue:  ……………………….

Professional qualification: ……………………………………………………………

4. The list of medical devices/groups of medical devices traded by the facility:

…………………………………………………………………………………………………………….

…………………………………………………………………………………………………………….

…………………………………………………………………………………………………………….

…………………………………………………………………………………………………………….

Declaration of eligibility for trading of medical devices

Enclosures:

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. The quality of the medical device will be ensured and the medical device will be circulated in accordance with the declaration.

3. Any changes related to the application for declaration of eligibility for trading will be updated as per regulations.

 

__________________________

¹ Geographic name

² Department of Health of the province/central-affiliated city where the facility is located

³ The address written on the business registration certificate

⁴ Making detailed declaration based on the existing persons

 

Template No. 10

 

Written request for issuance of medical device import licence

To: Infrastructure and Medical Device Administration (IMDA)

Name of importing organization or individual: …………………………………………………….

TIN or ID card number/Passport number: …………………………………………..

Legal representative: ………………………………………………………………

Phone number: ………………………………………………………………………..

We hereby apply for the license to import the following medical devices:

1. Purpose of import: …………………………………………………………………

2. User: ………………………………………………………………………..

3. We hereby declare:

– We will be responsible for ensuring the quality, model and quantity of imported medical devices

– The use of imported medical devices for their intended purposes will be ensured.

We will be responsible before law for breach of the above-mentioned commitments.

 

__________________________

¹ Geographic name

Template No. 11

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————

……¹………(date) ………………., 20…

WRITTEN REQUEST

for issuance of certificate of free sale of class C and class D medical devices

To: Infrastructure and Medical Device Administration (IMDA)

1. The facility applying for a CFS:

1.1. Name of the facility: ………………………………………………………………..

1.2. The headquarter address: ………………… ²……………………………………….

1.3. Phone number: ……………………. Fax: …………………………………………

2. The medical device owner:

2.1. The owner’s name: ………………………………………………………….

2.2. Address: …………………………………………………………………..

3. Manufacturing facility:

3.1. Manufacturing facility 1:

– Name: ………………………………………………………

– Address: ………….. ………………………………………………

3.2. Manufacturing facility 2:

– Name: ……………………………………………………….

– Address: ………….. ………………………………………………

To meet the requirements of the importing country, our company requests the IMDA of the Ministry to Health to issue a CFS for the following medical devices:

Number of printed copies of the CFS requested for issuance:

We hereby declare:

1. We included adequate documents in the application and ensure their accuracy, legitimacy and conformity with regulations. We will wholly be responsible for any falsification and will face penalties according to regulations of law.

2. The fulfillment and maintenance of requirements declared during the process of manufacture will be ensured.

 

__________________________

¹ Geographic name

² The address written on the business registration certificate

³ Numbering manufacturing facility according to section 3

 

Template No. 12

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————

…… ¹………(date) ………………., 20…

NOTIFICATION

OF UPDATED INFORMATION IN APPLICATION FOR DECLARATION OF ELIGIBILITY FOR PRODUCTION OF MEDICAL DEVICES

Last updated on: ………….

To: Department of Health …..

1. Number of declaration: ……………………. Date: ….………………………

2. Updated information:

3. Related  documents: ………………

We hereby declare:

We will strictly comply with regulations of Vietnamese law;

We will be responsible before the law for the accuracy of the updates.

 

__________________________

¹ Geographic name.

Template No. 13

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————

…… ¹………(date) ………………., 20…

NOTIFICATION

OF UPDATED INFORMATION IN APPLICATION FOR DECLARATION OF APPLIED STANDARDS OF CLASS A AND CLASS B MEDICAL DEVICES

Last updated on: ………….

To: Department of Health …..

1. Number of the applied standard declaration: ………………. issued on: ………

2. Updated information:

3. Related  documents: ………………

We hereby declare:

We will strictly comply with regulations of Vietnamese law;

We will be responsible before the law for the accuracy of the updates.

 

__________________________

¹ Geographic name.

Template No. 14

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————

…… ¹………(date) ………………., 20…

NOTIFICATION

OF UPDATED INFORMATION IN APPLICATION FOR MARKETING AUTHORIZATION OF CLASS C AND CLASS D MEDICAL DEVICES

Last updated on: ………….

To: Infrastructure and Medical Device Administration (IMDA)

1. Number of marketing authorization: ………. ….Date of issue: ………….……

2. Updated information:

3. Related  documents: ………………

We hereby declare:

We will strictly comply with regulations of Vietnamese law;

We will be responsible before the law for the accuracy of the updates.

 

__________________________

¹ Geographic name.

Template No. 15

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————

…… ¹………(date) ………………., 20…

NOTIFICATION

of updated information in application for declaration of eligibility for trading of class B, class C and class D medical devices

Last updated on: ………….

To: Department of Health …..

1. Number of declaration: ………….…. Date: ………………

2. Updated information:

3. Related  documents: ………………

We hereby declare:

We will strictly comply with regulations of Vietnamese law;

We will be responsible before the law for the accuracy of the updates.

 

__________________________

¹ Geographic name.

Template No. 16

 

DECLARATION

OF PLANNED MEDICAL DEVICE ADVERTISING CONTENTS AND FORMATS

To: Infrastructure and Medical Device Administration (IMDA)

1. Name of the facility²: ………………………………………………………………..

TIN: ………………………………………………………………………………….

Address: ……………………………………………………………………………………….

Tel: ………………………….. ………….. Fax: …………………………..

Email: ………………………………… …………. Website (if any): ………..

2. Legal representative of the facility:

Full name: ……………………………………………………………………………………

ID card number/Passport number: ……. Date of issue: ……… Place of issue:  …………………….

Landline: ………………….. Mobile phone: ………………………

3. Information on the medical device planned for advertisement:

– Name of the medical device: …………………………………………………………….

– Model: ……………………………………………………………………………

– Product code (if any): ……………………………………………………………

– Manufacturer: ……………………………………………………………………….

– Country of manufacture: ………………………………………………………………………

– Number of marketing authorization: ………………………………………………………………………….

– Features and functions: ……………………………………………………………..

– Name and address of holder of marketing authorization number: ………..

– Health warnings for users, storage conditions (if any):

…………………………………………………………………………………………………………

We hereby disclose the planned medical device advertising contents and formats as follows:

Planned advertising contents:

……………………………………………………………………………….

……………………………………………………………………………….

Planned advertising formats:

……………………………………………………………………………….

……………………………………………………………………………….

We hereby declare:

1. The disclosed 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. The advertising content complies with the planned advertising content that has been publicly disclosed and the application for disclosure of applied standards for class A or class B medical devices or the application for marketing authorization of class C or class D medical devices.

 

__________________________

¹ Geographic name

² The holder of marketing authorization number or the organization authorized in writing by the holder of marketing authorization number

 

APPENDIX II

PERSONNEL LIST TEMPLATE
(Enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the Minister of Health of Vietnam)

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————

…….¹….., ……[date]….., 20…

Personnel list

Name of the facility: ……………………………………………………………………………………………………………

Address: …………………………………………………………………………………………………………………

 

__________________________

¹ Geographic name.

 

APPENDIX III

TEMPLATE OF INFORMATION ABOUT APPLICATION FOR DECLARATION, CERTIFICATE, IMPORT LICENSE
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the Minister of Health)

Template No. 01

 

INFORMATION

about application for declaration of eligibility for production of medical devices

Number of declaration: …………….

Date of declaration: ………….

1. Name of manufacturing facility: ……………………………………………………………………

2. Address: ……………………………………………………………………………………

3. Tel: ………………………. Fax: ………………………………………………

4. Document number of the facility:…………………………………issued on: …………………….. …………

5. Name of medical device declared to be manufactured:

…………………. ……………………………………………………………………………….

6. Enclosures:

__________________________

¹ Department of Health of the province/central-affiliated city where the manufacturing facility is located

Template No. 02

 

INFORMATION

About Application for declaration of applied standards of class A medical devices

Number of declaration: …………….

Date of declaration: ………….

1. Name of the declaring facility: ……………………………………………………………………

2. Address: ……………………………………………………………………………………

3. Document number of the facility:…………………………………issued on:………………….. ……………………….

4. Class A medical device:

Name of the medical device: …………………………………………………………………………..

Trade name (if any): ……………………………………………………………….

Global Medical Device Nomenclature – GMDN code (if any):  …………….

Model: ………………………………………………………………………………….

Product code (if any): ………………………………………………………………….

Specifications of packing: ………………………………………………………………………

Uses: ………………………………………………………………………..

Name of manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: ………………………………………………………………….

Applied standards: ……………………………………………………………………..

5. For medical device that contains narcotic or precursor (if any):

Name of narcotic/ precursor: …………………. Scientific name: ……………

CAS Registry Number (CAS RN): ……………………………………………………………………….

Concentration and content of the narcotic or precursor: ……………………………………..

Total content of narcotics and precursors in a smallest packing unit:

………………………………………………………………………………………………………….

6. Information about the owner of the medical device:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ………………………………………………………………………

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 device:

.. ………………………………………………..…………………………………………..

9. Enclosures:

_________________________

¹ Department of Health of the province/central-affiliated city where the facility is located

 

Template No. 03

 

INFORMATION

ABOUT APPLICATION FOR DECLARATION OF APPLIED STANDARDS OF CLASS B MEDICAL DEVICES

Number of declaration: …………….

Date of declaration: ………….

1. Name of the declaring facility: ……………………………………………………………………

2. Address: ……………………………………………………………………………………

3. Document number of the facility:…………………………………issued on:………………….. ……………………….

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): ………………………………………………………………….

Specifications of packing: ………………………………………………………………………

Uses: ………………………………………………………………………..

Name of manufacturing facility: ……………………………………………………………………….

Address of the manufacturing facility: ………………………………………………………………….

Applied standards: ……………………………………………………………………..

5. For medical device that contains narcotic or precursor (if any):

Name of narcotic/ precursor: …………………. Scientific name: ……………

CAS Registry Number (CAS RN): ……………………………………………………………………….

Concentration and content: …………………………………………………………………….

Total content of narcotics and precursors in a smallest packing unit: ………………………..

6. Information about the owner of the medical device:

The owner’s name: ……………………………………………………………………………

Address of the owner of medical device: ………………………………………………………………………

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 device:

.. ………………………………………….

9. Enclosures:

__________________________

¹ Department of Health of the province/central-affiliated city where the facility is located

 

Template No. 04

 

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;

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;

Pursuant to Decree No. 96/2023/ND-CP dated December 30, 2023 of the Government elaborating on certain Articles of the Law on Medical Examination and Treatment;

Pursuant to Circular No. /2025/TT-BYT dated ……….., 2025 of the Minister of Health promulgating a Circular providing regulations on the delegation of implementation of some tasks and handling of some medical device-related administrative procedures under the jurisdiction of the Ministry of Health and regulations on templates of documents and reports on the management of medical devices.

The Infrastructure and Medical Device Administration of the Ministry of Health hereby grants a marketing authorization to the following brand-new medical device:

1. Name of the 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 the attached appendix.

8. Detail on medical device (model; product code; packing specification; name of manufacturing facility; address of manufacturing facility and country of manufacture):  See attached appendix.

This Certificate is granted in accordance with Decision No………

 

ENCLOSED APPENDIX

1. Uses:

2. Name, address of warranty facility:

3. Details on medical device:

Page……/……

Template No. 05

 

INFORMATION

about application for declaration of eligibility for trading of class B, class C and class D medical devices

Number of declaration: …………….

Date of declaration: ………….

1. Name of business facility: ………………………………………………………………………….

………………………………………………………………………………………………………….

2. Address: ………………………………………………………………………………………….

3. Document number of the facility:…………………………………issued on:………………….. …………………………….

4. Enclosures:

__________________________

¹ Department of Health of the province/central-affiliated city where the applicant is located

 

Template No. 06

Medical device import license

 

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;

Pursuant to Decree No. 96/2023/ND-CP dated December 30, 2023 of the Government elaborating on certain Articles of the Law on Medical Examination and Treatment;

Pursuant to Circular No. /2025/TT-BYT dated ……….., 2025 of the Minister of Health promulgating a Circular providing regulations on the delegation of implementation of some tasks and handling of some medical device-related administrative procedures under the jurisdiction of the Ministry of Health and regulations on templates of documents and reports on the management of medical devices.

Considering the request in Official Dispatch No. …………. dated…………… on ………….. The Infrastructure and Medical Device Administration of 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:

…..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 purposes.

 

__________________________

¹ Name of importing organization or individual.

Template No. 07

CERTIFICATE OF FREE SALE

1. Certificate No: ………….. /CFS/HTTB

2. Product Owner:

Address:

3. Information of medical devices: (Product name; Model; Product code; Market Authorization number in Vietnam and Manufacturing site): See attached annex.

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: …….

 

Page …/….

Attached Annex

Certificate of Free sale No:
…………………………..CFS/HTTB

I. Manufacturing site(s):

1. Name of Manufacturer:

Address:

2. Name of Manufacturer:

Address:

II. Name of Product(s):

1. Product name:

Model:

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 …/….

Template No. 08

INFORMATION

about application for declaration of concentration and content in materials for production of medical devices and EQA reagents that contain narcotics/precursors

Number of declaration: …………….

Date of declaration: ………….

1. Name of the declaring facility: ……………………………………………………………………………..

TIN: ……………………………………………………………………………………………

Address: ………………………………………………………………………………

Transaction office (if any): …………………………………………………………………

2. Legal representative of the facility:

Full name: ………………………………………………………………………..

ID card number/Passport number: ……. Date of issue: ……… Place of issue:  …………….

Landline: …………………………. Mobile phone: ……………………

3. Information on materials used for production of medical devices and eqa reagents that contain narcotics/precursors:

Product name: ………………………………………………………………………………….

Model: …………………………………………………………………………………………

Product code (if any): ………………………………………………………………………..

Packing specification (if any): …………………………………………………………………

Uses: ……………………………………………………………………………….

Applied standards: …………………………………………………………………………….

Name of manufacturing facility: ………………………………………………………………………………

Address of the manufacturing facility: …………………………………………………………………………

The owner’s name: …………………………………………………………………………………..

Address of the owner of medical device: ……………………………………………………………………………..

4. Information on narcotics/precursors contained in materials used for production of medical devices and EQA reagents:

Name of narcotic/ precursor: …………………………………………………………………..

Scientific name: …………………………………………………………………………..

CAS code ……………………………………………………………………………………………

Concentration and content: ……………………………………………………………………………

Total content of narcotics and precursors in a smallest packing unit: ……………………………….

5. Enclosures:

__________________________

¹ Department of Health of the province/central-affiliated city where the applicant is located

 

APPENDIX IV

TEMPLATE OF WRITTEN COMMITMENT AND APPLICATION FOR CONTINUED CIRCULATION OF CLASS C AND CLASS D MEDICAL DEVICES
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the Minister of Health)

Template No. 01

 

Written request for continued circulation of class C and class D medical devices and written commitments to take responsibility for warranty, preservation, provision of materials serving the use of medical devices

To: Infrastructure and Medical Device Administration (IMDA)

Name of the facility: …………………………………………………………………………………..

TIN: ………………………………………………………………………………….

Address: …………………………………………………………………………….. ………….

Legal representative: ………………………………………………………………

Phone number: …………………………………………………………………………

We are ….²…. . We are distributing the following medical devices:

Name of the medical device: ……………………………………………………………………..

Number of marketing authorization: …………………………. Date of issue: ………………………………………..

Although ………….³…………. is unable to continue operations, we still have the capacity to ensure the quality of the above medical devices. Therefore, we are writing this letter to formally request the IMDA affiliated to the Ministry of Health to allow the continued circulation of the above medical devices and hereby declare that:

– We will be responsible for ensuring the quality, model and number of medical devices granted marketing authorization number.

– The medical devices will be circulated on the market for a maximum period of 24 months.

– We will be responsible for the warranty, maintenance and servicing of such medical devices.

– We will provide materials and replacement accessories during the 8-year period of use.

– We have adequate and 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. The medical device labels meet requirements.

– Medical devices are used for their intended purposes. We will facilitate inspections by competent authorities.

We will be responsible before law for breach of the above-mentioned commitments.

 

__________________________

¹ Geographic name.

² Name of distributing facility.

³ Name of the medical device owner or name of the holder of the marketing authorization number.

 

Template No. 02

Written consents for continued circulation of class C and class D medical devices

 

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;

Pursuant to Circular No. /2025/TT-BYT dated ……….., 2025 of the Minister of Health promulgating a Circular providing regulations on the delegation of implementation of some tasks and handling of some medical device-related administrative procedures under the jurisdiction of the Ministry of Health and regulations on templates of documents and reports on the management of medical devices.

Considering the content of the proposal in Official Dispatch No. …….. dated ……. from ……………. on the request to continue the circulation of medical devices and the commitment to assume responsibility for warranty, maintenance and supply of materials for the use of medical devices, the IMDA of the Ministry of Health agrees with the proposal of the organization or individual regarding the circulation of medical devices. To be specific:

Name of the medical device: ………………………………………………………..

Number of marketing authorization: ……………………. Date of issue: …………………………….

The product is allowed to be circulated until the end of: ……………………………………………………

The company………. assumes responsibility for:

– ensuring the quality, model and quantity of medical devices granted marketing authorization number.

– providing warranty, maintenance and servicing of such medical devices.

– Providing materials and replacement accessories during the 8-year period of use.

– Ensuring that we have qualified personnel in charge of effectiveness and safety of medical devices for users and environment and the quality of the imported medical devices is not affected during transport and in our facilities. Meeting requirements for medical device labels.

– Ensuring that medical devices are used for their intended purposes. We will facilitate inspections by competent authorities.

 

 

APPENDIX V

LETTER OF AUTHORIZATION TEMPLATE
(Enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the Minister of Health of Vietnam)

Headline (name and address) of the medical device owner

…[date]……, 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:

“……….(List of the medical device)………”

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)

 

 

APPENDIX VI

CONFIRMATION OF ELIGIBILITY FOR WARRANTY TEMPLATE
(Enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the Minister of Health of Vietnam)

Headline (name and address) of the medical device owner: ……….

…[date]……, 20 ………………..

Confirmation of eligibility for warranty

First 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……………:

 

__________________________

¹ Full name of the owner of the medical device

 

APPENDIX VII

TEMPLATES OF TECHNICAL DOCUMENTS FOR MEDICAL DEVICES
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the Minister of Health)

Template No. 01

Technical documents for medical devices that are IVD reagents, calibrators, controls

Name and address of facility registering for circulation of medical device

………(date) ……………….., 20….

We certify that the above-mentioned information is true. We will be responsible before law for the above-mentioned information.

 

Template No. 02

Brief technical description of chemicals and preparations serving solely the purpose of disinfecting

MEDICAL DEVICES

Name and address of facility registering for circulation of medical device

………(date) ……………….., 20….

We certify that the above-mentioned information is true. We will be responsible before law for the above-mentioned information.

 

 

Template No. 03

Brief technical description of domestically manufactured medical devices which are neither IVD reagents, calibrators, controls nor chemicals and preparations serving solely the purpose of disinfecting medical devices

Name and address of facility registering for circulation of medical device

….[date]…., 20…

We certify that the above-mentioned information is true. We will be responsible before law for the above-mentioned information.

 

 

Template No. 04

Brief technical description of imported medical devices which are neither IVD reagents, calibrators, controls nor chemicals and preparations serving solely the purpose of disinfecting medical devices

Name and address of facility registering for circulation of medical device

………(date) ……………….., 20….

We certify that the above-mentioned information is true. We will be responsible before law for the above-mentioned information.

 

 

Template No. 05

Common Submission Dossier Template (CSDT)

Name and address of facility registering for circulation of medical device

We certify that the below-mentioned information is true. We will be responsible before law for the below-mentioned information.

1. General description of medical device

1.1. Brief description of medical device

Overview description of medical device, including: Introduction of the medical device, its purposes and indications for use and any new features if available (for example: use of nanotechnology, artificial intelligence, etc.).

1.2. Sales history of product on the market

Provide a list of countries in which the product was sold on the market, attached to the first year (if any) in which the product was sold on the market.

1.3. Purposes, indications for use

Specify purposes, indications for use of the medical device as stated on the label or in the device’s instruction manual.

1.4. Information of the grant of marketing authorization in countries

Provide information about the status of marketing authorization of the product in EU countries, Japan, Canada, Australia (TGA), USA (FDA), UK, Switzerland, including the licensing status (approved, pending approval, rejected, unregistered/non-registration, etc.), purposes, indications, initial authorization date¹.

This information may be presented in tabular form as follows:

Provide copies or links to online documents on the grant of marketing authorization in the above-mentioned countries (if any).

1.5. Important information regarding the safety and effectiveness of medical device

Provide brief information on adverse events that have been occurred, corrective actions for ensuring the safety in the market that have been taken since the products were introduced to the market or over the latest 5 years.

Provide brief information on adverse events that have been occurred, containing at least a description of the adverse events, number of adverse events or frequency of occurrence (total number of adverse events recorded per total number of products sold). This information may be presented in tabular form as follows:

Provide information on corrective actions for ensuring the safety in the market, containing at least date of occurrence, brief description of the event, and name of the country or territory that took corrective action. This information may be presented in tabular form as follows:

Provide a written confirmation from the products’ owner if there have been no adverse events, no corrective action since selling products or over the latest 5 years.

Indicate whether the medical device contains one of the following ingredients:

– 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 or derivatives of microbial or recombinant origin – e.g. hyaluronic acid-based dermal fillers obtained by bacterial fermentation, etc.

– Radioactive or ionizing ingredients (e.g. X-ray); or non-ionizing (E.g. laser, ultrasound, etc.).

2. Essential principles checklist (available in Vietnamese or English)

Provide a checklist of essential principles regarding the safety and effectiveness of medical devices issued by the medical device owner as prescribed in the Appendix enclosed to prove the product is suitable to the related essential principles.

If the medical device has been granted a marketing authorization in EU countries, an essential principles checklist may be made and submitted in accordance with EU regulations.

3.  Description of the medical device

3.1 Description and presentation of characteristics of the medical device

Provide a detailed description of characteristics of the medical device for explaining its operating principles, clarifying basic scientific concepts that make up the fundamentals of the medical device. Provide a description of components and accessories used to enable the operation and packaging of the device. Provide a full description of each functional component, material or raw material of the medical device, accompanied by a visual of the medical device in the form of a diagram, photograph or drawing, as appropriate.

3.2 Uses

State the intended use of the medical device matching the data provided by the product owner in the user manual as well as the operational capabilities of the medical device.

3.3 Indications

Provide a general description of the pathology or condition that the medical device diagnoses, treats, prevents or mitigates, including a description of the target patient group for which the medical device is designed to be used.

3.4 User manual

All necessary information provided from the product owner including procedures, methods, frequency, timing, quantities and preparations that must be followed for the safe use of the medical device.

3.5 Contraindications

Provide information regarding cases where the medical device is not to be used due to patient safety reasons, for example, due to the patient’s medical history, physiological characteristics, etc., in accordance with the contents stated on the label of the medical device or user manual of the medical device.

Provide a description of diseases or cases and patient groups for which medical devices are not to be used for the purpose of diagnosis, treatment or alleviation of disease. Contraindications are cases in which the use of medical devices is not permitted because the risks clearly outweigh the potential benefits.

3.6 Warning

Provide warnings about specific dangers that users need to know before using medical devices.

3.7 Precautions

Warn users to take necessary precautions for the safe and effective use of medical devices. This may include actions that need to be taken to avoid effects to the patients/users; such effects may not pose a life-threatening risk or cause serious injury but the users should be aware of them. Precautions may also warn users about the adverse effects when using or incorrectly using the medical devices, which can be avoided if the precautions are taken.

3.8 Potential adverse effects

These are unwanted and serious consequences (death, injury, or serious adverse events) that may occur to the patient/user, or side effects from the use of the medical device under normal conditions.

3.9 Alternative therapy

Describe alternative procedures or actions for diagnosing, treating or alleviating the disease or condition for which the medical device is intended.

3.10 Materials (which may be listed in English or Vietnamese)

Describe materials of the medical device and its characteristics for proving the conformity with relevant essential principles.

Regarding a non-IVD medical device:

A list of materials of the medical device that come into direct contact with the body (E.g. Mucous membrane) and indirect contact with the body (e.g. circulation of extracellular fluid (ECF)), and their chemical, biological and physical characteristics shall be provided.

Regarding medical devices that emit ionizing radiation, information about sources of radiation (e.g. radioactive isotopes) and materials used to protect users and patients from unexpected radiation must be provided.

In cases where there are special requirements regarding the safety of a material such as impurities, level of residue and exposure to plasticizers such as Bis (2- ethylhexyl) phthalate (DEHP), a certificate of conformity to relevant standards, a certificate of analysis, or a safety assessment report of such material should be added. Depending on risks incurred when exposing to these materials, additional measures may be required, such as notifying users of the presence of these materials by labeling the on the product.

For IVD reagents, calibrators, controls:

A list of all the materials used in the production of the product, including name of material and its role in the finished product shall be provided.

Information about the composition, biological characteristics, and origins of materials involved in the testing reactions: antigens, antibodies, enzymes, conjugates, PCR primers, probes, calibrators, controls, etc. shall be provided.

For medical devices containing substances requiring special control (narcotics or radiation-producing materials, either non-ionizing or ionizing), it is required to provide adequate information about the composition, content and role of these substances, for example, Buprenorphine in drug testing kits, Iodine-131 in radioimmunoassay kits, Phosphorus-32 (32P) -labeled DNA probes in Southern blot methods, etc.

For class C and class D IVD medical devices Information on the standards or certificate of analysis of the main materials involved in the reactions (excluding stabilizers) shall be provided. The information described for each active material (antigen, antibody, multiplex PCR, etc.) shall be provided.

3.11 Other relevant specifications

Characteristics of the functions and technical specifications regarding the operation of medical devices include: accuracy, sensitivity, specificity of medical measuring and diagnostic devices, reliability and other factors (if relevant); and other specifications including chemistry, physics, electricity, mechanics, biology, software, sterility, stability, storage, transportation and packaging for proving the conformity with relevant essential principles.

3.12 Other information

Other important characteristics that are not mentioned above for proving the conformity with relevant essential principles (for example: the biocompatibility of medical devices, etc.).

Notes:  in cases where the above-mentioned information is provided in the user manual, the user manual may be used for reference

4. Synopsis of design verification and validation (in Vietnamese or English)

This section must summarize, refer to or include design verification data and design validation data, appropriate to the complexity and risk classification of the medical device.

This document includes:

Certificates or declarations of conformity to the recognized standards applied by the product owner; and/or

Summaries or trial reports and evaluations based on other standards, methods and trials of the manufacturer, or other means to demonstrate compliance with the product standards.

E.g. If the essential principles checklist mentions that the manufacturer uses a recognized standard to demonstrate conformity with an essential principle, a Declaration of Conformity to that standard must be provided, or a certificate of conformity, and a summary of the trial data if that standard does not include performance requirements.

Summaries of data or trial reports and evaluation, depending on the complexity and classification of the risk level of medical devices, typically include:

The list and conclusions drawn from published reports related to the safety and efficacy of medical devices in accordance with the essential principles;

Technical tests;

Laboratory tests;

Biocompatibility tests;

Animal experiments;

Using under simulated conditions;

Software evaluation.

4.1 Preclinical investigations

Detailed information on all biocompatibility tests performed on materials used in the medical device shall be provided. All significantly different materials must be described. Description of tests, results and data analyses must be provided.

Physical preclinical testing data must be fully provided, as appropriate. A report must include objectives, methods, results and conclusions of the product’s owner for all physical investigations of the medical device and components. Physical testing shall be performed to forecast the adequate response of the medical device to physical pressure, adverse conditions and effects, long-term use and all known and probable causes of device failure.

Reports on preclinical investigations on animals used to demonstrate possible effects of the medical device on humans shall be provided. These investigations must be conducted in compliance with good laboratory practice (GLP). A report must include objectives, methods, results, analyses and conclusions of the product’s owner. Conclusions of each investigation must address the interactions of the medical device with animal fluids and tissues and the effectiveness of the medical device in experimental animal model(s). Rationales (and limitations) of choosing specific animal models should be discussed.

Evidences of electrical safety and electromagnetic compatibility shall be provided. For example, if the owner declares that the product meets the requirements of IEC 60601-1 and IEC 60601-1-2, a test summary report and/or certificate of conformity must be provided to demonstrate that the medical device meets these standards.

Regarding sterilized medical devices, sterilization validation reports must be provided. If a sterilant is toxic or produces a toxic residue (e.g., Ethylene Oxide), data and test methods must be provided to demonstrate that the amount of sterilant or residue is within acceptable limits.

Evidences of cybersecurity for network-connected, internet-connected or wireless medical devices shall be provided. Such as: analyses of risks and possibilities of cyber attacks, cyber security control methods, plans, processes or mechanisms for monitoring, promptly detecting and managing security-related threats during the life cycle of the medical device. Declarations from the manufacturer or the owner stating that the medical device, which is network-connected, internet-connected or wireless-connected, ensures cyber security and safety may be provided.

4.1.1 Software verification and validation investigations (if applicable)

The correctness of a software product is another important characteristic of the product that cannot be fully validated in a finished product. The product owner must provide evidence confirming the software design and development process. This information includes results of the verification, validation and testing of the software done internally and in user’s environments prior to official launch, for all different hardware configurations such as mentioned on the label or in the user manual, as well as representative data obtained from both trial environments.

4.1.2 Medical device containing biological materials

It is required to provide results of investigation demonstrating that measures for facing dangers from infectious agents have been fully implemented. This section will include results of removing viruses and known hazards. Concerns about screening of donors must be fully addressed and methods of obtaining human material should be fully described. Results of process validation are required to demonstrate that manufacturing processes have been applied to minimize biological risks.

4.2 Preclinical investigations for IVD reagents, calibrators, controls

4.2.1 Analytical performance

It is required to provide investigation reports on the analytical performance of the medical device, including: analytical sensitivity, analytical specificity, limit of detection (LOD), limit of quantitation (LOQ), linearity, range, accuracy, repeatability, interfering substances, robustness, etc.  Performance criteria will depend on each medical device.

Information on samples used for evaluation (negative controls, positive controls, baseline standards, calibrator panels, reagents, …).

Investigation reports should include objectives, methods, results, and conclusions of the investigation.  The results and conclusions should clearly demonstrate that the product has the characteristics suitable for its intended use.

4.2.2 Stability

It is required to provide stability investigation reports, including both real-time shelf-life stability and accelerated shelf-life stability (if applicable). In the event that real-time shelf-life stability investigations are not conducted but only accelerated shelf-life stability investigations are conducted, a comprehensive and reasonable explanation is required.

In-use stability investigation reports for products that are repeatedly used after opening shall be provided.

It is required to provide shipping stability investigation reports, in which the products are shipped under real or simulated conditions.

Stability investigation reports must include objectives, methods, results, and conclusions.

4.3 Clinical evidence

A clinical evaluation report of the medical device shall be provided. This evaluation may be taken in the form of a systematic review of available references, based on clinical experience with that medical device or similar medical device, or may be conducted through clinical investigations. Clinical investigations are often necessary for high risk medical devices, or medical devices where there is little or no clinical experience.

A clinical evaluation report should include purposes and context of the clinical evaluation, input clinical data, data appraisal and analysis, conclusions about safety and effectiveness of the medical device.

The clinical evaluation report should contain sufficient information as a standalone document for a regulatory authority to review. The clinical evaluation report should provide an overview of:

– Technology used by such medical device, indications for use, statements about the safety and clinical effectiveness of that medical device, if any.

– Nature and scope of the clinical data to be evaluated.

– Clinical data and recognized standards proving the safety and effectiveness of the medical device.

4.3.1 Data collected from available references

If the product’s owner uses existing investigations and references to prove the safety and effectiveness of the medical device, copies of these documents should be provided.

Clinical evidences of the effectiveness may include medical device-related investigations conducted in Vietnam or other countries. These evidences may be collected from related investigations published in international medical journals.  Documents on clinical evidences must include objectives, methods and results presented in a clear and meaningful context. Before reaching conclusions of results of clinical investigations, discussions in context with published documents are required.

4.3.2 Data collected from clinical experience

Clinical experience is clinical data obtained from clinical use of the medical device, not from clinical investigations. Clinical experience may be of the medical device or comparable devices.

Clinical experience may be obtained from the following data:

Post-market surveillance reports of the product’s owner, regulatory authorities, cohort investigations (may contain unpublished long-term investigation data on safety and effectiveness).

Data on adverse events occurred obtained from the product’s owner or from regulatory authorities.

Data obtained from patients using the medical device in the pre-market aid program.

Information on clinically relevant field corrective actions such as recalls, notifications, hazard warnings.

4.3.3 Clinical investigation data

A clinical investigation is a systematic study on or in human subjects, undertaken to assess the safety and effectiveness of a medical device.

The clinical investigation may be undertaken by the medical device’s owner or by a third party representing the owner. The clinical investigation should be designed, conducted and reported in conformity with ISO 14155 standards, Part 1 and 2, Clinical Investigations of Medical Devices for Human Subjects, or in conformity with an equivalent standard, and in compliance with regulations of the host country.

The clinical investigation must conform to the ethical standards of the Declaration of Helsinki (DoH).

For an IVD medical device: Clinical investigations are investigation conducted to establish or validate the clinical performance of IVD medical devices. Manufacturers must provide clinical evidence to support their clinical claims, including: diagnostic sensitivity (clinical sensitivity) and diagnostic specificity (clinical specificity).

5. Labels of medical device

This is the descriptive and informational product literature that accompanies the medical device, such as: any physician/user manuals, pack labeling. This section must summarize, refer to or include the following labeling data to the extent appropriate to the complexity and risk class of the medical device, which is generally considered as “labeling”:

● Labels on the medical device and its packaging;

● User manual;

● Any information and instructions given to the patient, including instructions for any procedure the patient is expected to perform (if applicable).

5.1 Label samples on the medical device and its packaging

Label samples including information on the product must be presented in print, text or images, provided or attached to one or more layers of packaging, including secondary packages and primary packages. If it is impossible to provide physical label samples (e.g. a large warning label attached to an X-ray machine), the information may be provided in an alternative form, such as an image or technical drawing.

Label samples must meet requirements in accordance with regulations of applicable laws. As for imported medical devices, the label samples must include primary and secondary labels in Vietnamese.

The label sample must include all products stated in the application for marketing authorization. In case the application is submitted according to the medical device family, a label sample as a representative sample with a note of differences between label samples of the medical device shall be submitted.

5.2 User manual in Vietnamese

The user manual includes instructions for the physician or end user to use the medical device safely and for its intended use. The user manual should include indications, contraindications, warnings or precautions, potential adverse effects, alternative therapies, and conditions of storage and use to maintain safety and effectiveness of the medical device.

For IVD medical devices, the user manuals include the following information (if applicable):

– Type and code (if any) of the IVD medical device.

– Uses:

• Detect or measure something;

• Its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, predicting);

• Use of the same medical device (testing machine) whether it is automated or not;

• Whether it is quantitative or semi-quantitative or qualitative or identificatory, etc.;

• The type of specimen(s) required (e.g. serum, plasma, whole blood, tissue biopsy, urine);

• Testing population.

– Instructions: the product is used for IVD.

– The intended user (lay person or professional, etc.);

– The principle of the assay.

– Description of reagents, calibrators, reference materials, controls and limitations associated with their use (e.g. intended for use with a specific testing machine only).

– A list of provided materials and a list of specially required materials that are not provided.

– For IVD medical devices used in conjunction with other medical devices and/or in combination with non-medical devices or instruments:

• Information for identifying these devices or instruments, including important performance characteristics.

• Information on known restrictions when combining with those devices or instruments.

– Special storage conditions (e.g. Temperature, light, humidity and the conditions under which medical devices are used, if applicable.

– The in-use stability may include storage conditions and the shelf life after the first opening; storage conditions and the stability of working solutions, if applicable. The product’s lifespan must be clearly stated in the user manual.

– If a medical device is provided in a sterile form, it is necessary to specify that the medical device is sterile, specify the sterilization method and the handling instructions in the event that the sterile packaging is damaged prior to use.

– The information that allows users to be informed about any warnings, precautions, necessary measures to be taken and usage restrictions for IVD medical devices. This information should include, if applicable:

• Warning, precautions and/or measures to be taken in the event that the IVD medical device is damaged or malfunction or degradation reflected through the change in the external form of the medical device may affect performance.

• Warnings, precautions and/or measures to be taken regarding exposure to foreseeable external influences or environmental conditions, such as external magnetic fields, electricity and electromagnetic forces, electric discharges, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature;

• Warnings, precautions and/or necessary measures to be taken regarding potential risks during the use of the medical device in specific diagnosis, evaluation and treatment (e.g., electromagnetic interference emitted by the device affecting other devices);

• Precautions related to materials incorporated into the medical device that contain carcinogens, mutagens or substances harmful to reproduction, endocrine disruptors, or substances that may cause sensitivity or allergic reactions in patients.

– Conditions for collecting, handling and preparing specimen.

– Instructions for preparing or handling medical devices before use, such as sterilization, assembly, calibration, etc., to ensure that the device is used in accordance with the owner’s intended purpose.

– The necessary information to determine when IVD medical device is properly installed and ready to operate safely and as intended by the owner, along with the following information, when applicable:

• Details about the nature and frequency of preventive maintenance and scheduled maintenance, including cleaning or disinfection;

• Consumables and how to replace them;

• Information regarding the calibration that needs to be performed to ensure that medical device operates correctly and safely throughout its life cycle;

• Measures to mitigate risks encountered by individuals involved in installation, calibration or repair, such as contaminated surfaces.

– Recommendations on the quality control process when necessary.

– Instructions on how to retrieve the values assigned to calibrators and controls, including information for identifying reference materials and the reference measurement procedures used.

– The process of conducting tests includes calculating and interpreting results and recommending additional confirmatory tests if appropriate.

– The analytical performance characteristics, such as sensitivity, specificity and precision (which is a combination of trueness and accuracy).

– Clinical performance characteristics, such as diagnostic sensitivity and diagnostic specificity when applicable.

– Reference range when applicable.

– Information about interfering substances or limits (e.g., visual evidence of hyperlipidemia or hemolysis, the specimen storage duration) may affect the execution of the analysis.

– Warnings or precautionary measures to be taken regarding the disposal of the device, its accessories and consumables used together with it, if any. This information should include the following contents, if applicable:

• Hazards related to infection or microorganisms (e.g., consumables contaminated with substances capable of transmitting infections of human origin);

• Environmental hazards (e.g., batteries or radiative materials that emit potentially hazardous radiation);

• Physical hazards (e.g., explosions).

– For IVD medical devices used by lay persons, it is necessary to advise users to seek the opinions of healthcare professionals before making any medical decisions.

– References, if applicable.

– The name and address of the owner must be presented in a recognizable format that allows for the identification of the owner’s information. In cases where the user manual contains information about the manufacturing facility and origin, this information must include complete details regarding the name and address of the manufacturing facility.

– Document identification information, such as version number or release date.

6. Risk analysis (written in either Vietnamese or English)

This section must summarize, refer to or include the results of the risk analysis. This risk analysis is based upon international standards or other recognized standards, and is appropriate to the complexity and risk classification of the medical device.

Results of risk analysis

A list of possible risks for the medical device shall be provided. Indirect risks from the medical device may originate from hazards related to the medical device itself, such as moving parts causing long-term injuries, or from hazards related to the user, such as ionizing radiation from an X-ray machine. Assessments of these risks in relation to the declared benefits of the medical device and methods used to reduce risks to an acceptable level must be presented. Individuals or organizations analyzing risks must be identified clearly. Techniques used to analyzing risks must be defined to ensure the appropriateness to the medical device and the risks involved.

7. Information on manufacture (in Vietnamese or English)

This section must summarize, refer to or include documents related to the manufacturing processes, including quality assurance measures, in accordance with the complexity and risk classification of medical devices.

7.1 Manufacturer’s information

The names and addresses of the manufacturers participating in the processes of manufacture and sterilization (including third-parties).

7.2 Manufacturing process

It is required to include information serving the general perception of the manufacturing process. No proprietary details are required. This information can be presented in the form of a manufacturing flow diagram that briefly describes the process of manufacture, in-process quality control, assembly, quality control and packaging of the final product.

If multiple manufacturers are involved in the manufacturing process to complete a product, it is necessary to clearly state which activities each manufacturer is involved in.

 

__________________________

¹For products granted a certificate of marketing authorization in EU countries, the latest grant date may be written if the initial authorization date is not stated.

APPENDIX

Essential principles checklist

(in English or Vietnamese)

Name of the owner of the medical device:

Name of the medical device:

Product code (if any):

Template No. 06

Brief technical description of medical devices serving the issuance of import licenses

Name of the importing facility (name, address)

………(date) ……………….., 20….

We certify that the above information is true. We will be responsible before law for the above-mentioned information.

 

 

APPENDIX VIII

TEMPLATE OF REPORT ON RECEIPT, DISPATCH, INVENTORY, USE OF MEDICAL DEVICES, PRODUCTION MATERIALS, EQA REAGENTS THAT CONTAIN NARCOTICS/PRECURSORS
(enclosed with Circular No. 44/2025/TT-BYT dated November 22, 2025 of the Minister of Health)

 

REPORT ON RECEIPT, DISPATCH, INVENTORY, USE IN …………
OF MEDICAL DEVICES AND EQA REAGENTS THAT CONTAIN NARCOTICS/PRECURSORS

To: .…………….………………………

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.

 

_________________________

¹ Specify quantity of production materials.

² Including the quantity of destroyed products and expired products, etc. If any, a detailed report is required