Circular No. 59/2025/TT-BYT amends Circular No. 05/2022/TT-BYT guiding Decree No. 98/2021/NĐ-CP on medical device management.

CIRCULAR

AMENDMENTS AND SUPPLEMENTS TO CERTAIN ARTICLES OF CIRCULAR NO. 05/2022/TT-BYT DATED AUGUST 1, 2022 ISSUED BY THE MINISTER OF HEALTH ON THE DETAILING IMPLEMENTATION OF CERTAIN PROVISIONS OF DECREE NO. 98/2021/NĐ-CP DATED NOVEMBER 8, 2021 OF THE GOVERNMENT ON MEDICAL EQUIPMENT MANAGEMENT

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

Pursuant to Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical equipment management, amended and supplemented by Decrees No. 07/2023/NĐ-CP, No. 96/2023/NĐ-CP, and No. 04/2025/NĐ-CP;

At the proposal of the Director of the Medical Infrastructure and Equipment Department,

The Minister of Health issues this Circular amending and supplementing certain articles of Circular No. 05/2022/TT-BYT dated August 1, 2022 issued by the Minister of Health detailing the implementation of certain provisions of Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical equipment management.

Article 1. Amends and supplements certain articles of Circular No. 05/2022/TT-BYT dated August 1, 2022 issued by the Minister of Health detailing the implementation of certain provisions of Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on medical equipment management.

Amends Article 8 as follows:

“Article 8. Implementation timeline

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

1. Purchases made after June 30, 2026 must have their safety and technical performance tested according to the testing procedures issued by the Minister of Health;

2. Purchases made before July 1, 2026 may continue to be used but must complete their safety and technical performance testing according to the testing procedures issued by the Minister of Health by December 31, 2026. Medical facilities bear full responsibility under the law for ensuring patient safety when using these medical devices during the period prior to testing.”

Article 2. Effective Date

This Circular takes effect from the date of issuance.

Article 3. Implementation

1. The Medical Infrastructure and Equipment Department shall be responsible for:

a) Taking the lead and coordinating with relevant agencies and units to implement this Circular;

b) Promoting and encouraging the development of additional testing facilities for medical equipment in accordance with regulations;

c) Strengthening inspections, supervision, and urging the completion of medical equipment testing at testing units and medical facilities.

2. Heads of medical facilities shall be responsible for:

a) Conducting medical equipment testing in accordance with regulations;

b) Managing, maintaining, and using medical equipment in compliance with manufacturer guidelines;

c) Regularly inspecting and evaluating the quality of medical equipment and reporting non-compliant equipment to the regulatory authority as required.

During the implementation process, if there are difficulties or obstacles, organizations and individuals shall report them to the Ministry of Health (Medical Equipment Infrastructure Department) for consideration and resolution.