Circular 24/2026/TT-BYT amend Circular 05/2022/TT-BYT on risk classification and management of medical equipment

CIRCULAR

Providing for risk classification and management measures applicable to medical equipment, and amending and supplementing a number of articles of Circular No. 05/2022/TT-BYT detailing a number of articles of the Decree No. 98/2021/ND-CP on the management of medical equipment

Pursuant to the Law on Treaties No. 108/2016/QH13;

Pursuant to the Law on Product and Goods Quality No. 05/2007/QH12, amended and supplemented under Law No. 78/2025/QH15;

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

Pursuant to the Government’s Decree No. 98/2021/ND-CP on management of medical equipment, amended and supplemented under 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. 37/2026/ND-CP detailing a number of articles of, and providing measures for organizing and guiding the implementation of, the Law on Product and Goods Quality;

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

The Minister of Health hereby promulgates the Circular providing for risk classification and management measures applicable to medical equipment, and amending and supplementing a number of articles of Circular No. 05/2022/TT-BYT detailing a number of articles of the Decree No. 98/2021/ND-CP on the management of medical equipment.

Article 1. Scope of regulation

This Circular specifies:

1. Risk classification and management measures applicable to medical equipment.

2. Amendments and supplements to a number of articles of Circular No. 05/2022/TT-BYT detailing a number of articles of Decree No. 98/2021/ND-CP on management of medical equipment.

Article 2. Risk classification and management measures applicable to medical equipment

1. The determination of risk levels and the corresponding management measures applicable to medical equipment shall be carried out in accordance with Decree No. 98/2021/ND-CP and its guiding documents.

2. HS codes applicable to medical equipment shall be those prescribed in Circular No. 19/2024/TT-BYT promulgating the List of imported and exported medical equipment with commodity codes determined according to Vietnam’s Nomenclature of Exports and Imports.

Article 3. Amending and supplementing a number of articles of Circular No. 05/2022/TT-BYT detailing a number of articles of Decree No. 98/2021/ND-CP on management of medical equipment

To amend and supplement Article 8 as follows:

“Article 8. Implementation roadmap

For medical equipment specified in Clauses 1, 2, 3, 4, 5 and 6, Article 5 of this Circular:

1. Medical equipment purchased after June 30, 2027, must be subject to safe and technical inspection in accordance with the inspection procedures promulgated by the Minister of Health.

2. Medical equipment purchased before July 01, 2027, must completely undergone safe and technical inspection before January 01, 2028, in accordance with the inspection procedures promulgated by the Minister of Health.”.

Article 4. Effect

1. This Circular takes effect from July 01, 2026.

2. Circular No. 59/2025/TT-BYT amending and supplementing a number of articles of Circular No. 05/2022/TT-BYT detailing a number of articles of Decree No. 98/2021/ND-CP on management of medical equipment, ceases to be effective from the date this Circular comes into force.

Article 5. Reference provisions

In case any documents referred to in this Circular are amended, supplemented or replaced, the new ones shall prevail.

Article 6. Implementation organization

Vietnam Infrastructure and Medical Device Administration, Chief of the Ministry Office, Heads of agencies and units under the Ministry of Health and relevant organizations and individuals shall implement this Circular.

Any difficulties arising in the course of implementation shall be reported to the Ministry of Health (the Agency for Health Infrastructure and Medical Equipment) for consideration and settlement./.