Circular No. 59/2025/TT-BYT amends Circular No. 05/2022/TT-BYT on medical device management, stipulating the inspection schedule for safety and technical performance of specific types of medical devices. This document applies to healthcare facilities from the date of issuance.
适用范围
Healthcare facility
要点
- Healthcare facilities purchasing equipment after June 30, 2026 must inspect the safety and technical performance of medical devices (Article 8, Clause 1).
- Healthcare facilities purchasing equipment before July 1, 2026 may continue to use them but must complete the safety and technical performance inspections by December 31, 2026 (Article 8, Clause 2).
- Healthcare facilities are responsible for ensuring patient safety when using untested medical devices (Article 8, Clause 2).
- The head of a healthcare facility must manage, maintain, and use medical devices in accordance with the manufacturer's instructions (Article 3, Clause 2 a).
- Healthcare facilities must regularly check the quality of medical devices and report to the supervisory authority if they find any non-compliance with quality standards (Article 3, Clause 2 c).
🌐 本文件的社会影响
- Enhance safety in the use of medical devices to protect patients' health.
- The burden of time and cost for healthcare facilities when conducting medical device inspections.
- Encourage the development of more medical device inspection facilities.
❓ 常见问题
What is the purchase date after which healthcare facilities must conduct inspections?
After June 30, 2026 (Article 8, Clause 1).
What is the latest deadline for completing inspections for medical devices purchased before which date?
Before December 31, 2026 (Article 8, Clause 2).
What responsibility does a healthcare facility have when using untested medical devices?
Ensure patient safety (Article 8, Clause 2).
全文
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
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NUMBER: 59/2025/TT-BYT |
Hanoi, December 31, 2025 |
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.
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Place of Receipt: |
DEPUTY MINISTER (Signed)
Do Xuan Tuyen |
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