Circular 44/2025/TT-BYT decentralization in administrative procedures related to medical devices

CIRCULAR

Defining the decentralization in implementation of certain tasks and handling of certain administrative procedures in the field of medical devices under the Ministry of Health’s competence, and forms of documents and reports for management of medical devices

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

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

Pursuant to the Government’s Decree No. 217/2025/ND-CP dated August 15, 2018, on specialized inspection activities;

Pursuant to the Government’s Decree No. 42/2025/ND-CP dated February 27, 2025, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Agency for Health Infrastructure and Medical Equipment,

The Minister of Health promulgates the Circular defining the decentralization in implementation of certain tasks and handling of certain administrative procedures in the field of medical devices under the Ministry of Health’s competence, and forms of documents and reports for management of medical devices.

Article 1. Scope of regulation

This Decree provides:

1. The decentralization in implementation of certain tasks and handling of certain administrative procedures in the field of medical devices under the Ministry of Health’s competence.

2. Forms of documents and reports for management of medical devices under Clause 12 Article 70 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

Article 2. Decentralization in implementation of certain tasks and handling of certain administrative procedures in the field of medical devices under the Ministry of Health’s competence to the Agency for Health Infrastructure and Medical Equipment

1. Grant of registration numbers of type-C and type-D medical devices specified in Article 32 and Article 32a of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

2. Inspection after grant of registration numbers of type-C and type-D medical devices specified in Clause 3 and Clause 4 Article 32 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

3. Suspension from circulation of defective medical device batches on the market or termination of suspension from circulation of defective medical device batches on the market specified in Clause 3 Article 34 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

4. Recalling of batches of defective medical devices specified in Clause 4 Article 34 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

5. Issuance of documents indicating whether or not the medical devices may be placed on the market as defined in Article 37 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

6. Revocation of registration numbers of medical devices specified in Article 39 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

7. Grant of import licenses of medical devices specified in Article 48 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

8. Grant, re-grant and revocation of Certificates of Free Sale of medical devices specified in Article 50 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

9. Grant, revision and revocation of Certificates of registration of medical devices inspection services specified in Article 56 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

10. Decision on handling of unqualified medical devices defined in Article 58 of the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

11. Specialized inspection towards organizations and individuals performing activities of: classification of medical devices; production, circulation, trading, export, import, and provision of medical device services; medical device information and advertising; and management and use of medical devices at health facilities as defined in Clause 1, Article 6 of Decree No. 217/2025/ND-CP.

Article 3. Forms of documents and reports for management of medical devices

Promulgate together with this Circular forms of documents and reports for management of medical devices specified in the Decree No. 98/2021/ND-CP, which was amended and supplemented by the Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.

1. Appendix I: Forms of documents for publicization, declaration, notification, and request for grant of new circulation registration numbers, import licenses, and Certificates of Free Sale.

2. Appendix II: Form of personnel list.

3. Appendix III: Forms of information on the dossiers for publicization, certificates, and import licenses of medical devices.

4. Appendix IV: Forms of written commitment and request for continuation of circulation of the medical devices on the market.

5. Appendix V: Form of authorization letter.

6. Appendix VI: Form of Certificate of eligibility to provide warranty services.

7. Appendix VII: Forms of technical documents of medical devices.

8. Appendix VIII: Form of report on release from warehouse, receipt into warehouse, inventory, and use of medical devices, raw materials for manufacture, and substances for external quality assessment that contain narcotic substances and precursors.

Article 4. Effect

1. This Circular takes effect on November 22, 2025.

2. Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health defining the forms of documents and reports for the implementation of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021, on the management of medical devices, which was amended and supplemented by the Circular No. 10/2023/TT-BYT cease to be effective from the effective date of this Circular.

Article 5. Transitional provision

1. For dossiers that have been submitted to the management agency before the effective date of this Circular and use forms defined in Circular No. 19/2021/TT-BYT, amended and supplemented by the Circular No. 10/2023/TT-BYT: If the document or report expires or requires amendment or supplementation, the organizations or individuals, when updating, amending, or supplementing their dossiers, must comply with the forms issued together with this Circular.

2. Authorization letters and Certificates of eligibility to provide warranty services that were signed and issued by the holders of medical devices, made using the forms defined in Circular No. 19/2021/TT-BYT, amended and supplemented by the Circular No. 10/2023/TT-BYT before the effective date of this Circular and are still valid, shall continue to be used.

Article 6. Organization of implementation

The Chief of the Ministry Office, Directors of the Department of Organization and Personnel, the Department of Legal Affairs and the Agency for Health Infrastructure and Medical Equipment, and relevant agencies, organizations, and individuals shall be responsible for implementing this Circular.

Any problems arising in the course of implementation of this Circular should be promptly reported to the Ministry of Health (the Agency for Health Infrastructure and Medical Equipment) for timely consideration and handling./.

* All Appendices are not translated herein.