List of Vietnam Law
Circular No. 59/2025/TT-BYT dated December 31, 2025 of the Ministry of Health of Vietnam on amendment to Circular No. 05/2022/TT-BYT dated August 1, 2022 of the Ministry of Health elaborating Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices
Date: 12/31/2025
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THE MINISTRY OF HEALTH OF VIETNAM
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness ---------------- |
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No. 59/2025/TT-BYT
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Hanoi, December 31, 2025
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CIRCULAR
AMENDMENT TO CIRCULAR NO. 05/2022/TT-BYT DATED AUGUST 1, 2022 OF THE MINISTER OF HEALTH ELABORATING DECREE NO. 98/2021/ND-CP DATED NOVEMBER 8, 2021 OF THE GOVERNMENT ON MANAGEMENT OF MEDICAL DEVICES
Pursuant to Decree No. 42/2025/ND-CP dated February 27, 2025 of the Government on functions, tasks, powers, and organizational structures of Ministry of Health;
Pursuant to Decree No. 98/2021/ND-CP dated November 8, 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;
At request of Director of Vietnam Infrastructures and Medical Device Administration,
The Minister of Health promulgates Circular on amendment to Circular No. 05/2022/TT-BYT dated August 1, 2022 of the Minister of Health elaborating Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices.
Article 1. Amendment to Circular No. 05/2022/TT-BYT dated August 1, 2022 of the Minister of Health elaborating Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices.
Amend Article 8:
“Article 8. Roadmap for implementation
Regarding medical devices under Clauses 1, 2, 3, 4, 5, and 6 Article 5 hereof:
1. Medical devices procured after June 30, 2026 must undergo inspection for safety and technical characteristics of medical devices in accordance with inspection procedures of the Minister of Health;
2. Medical devices procured before July 1, 2026 are eligible for use and must undergo inspection for safety and technical characteristics of medical devices in accordance with inspection procedures of the Minister of Health before December 31, 2026. Medical establishments are entirely legally responsible for safety of patients in the use of these medical devices before inspection is conducted.”.
Article 2. Entry into force
This Circular comes into force from the date of signing.
Article 3. Organizing implementation
1. Vietnam Infrastructures and Medical Device Administration has the responsibility to:
a) take charge and cooperate with relevant agencies and entities in implementation of this Circular;
b) communicate and encourage additional development of medical device inspecting facilities as per the law;
c) strengthen inspection, supervision, and encouragement of medical device inspection and inspecting facilities and medical establishments.
2. Figureheads of medical establishments have the responsibility to:
a) inspect medical devices as per the law;
b) implement management, maintenance, warranty, and use of medical devices in a manner compliant with instructions of manufacturers;
c) regularly inspect, evaluate quality, and report unsatisfactory medical devices to governing authorities as per the law.
Difficulties that arise during implementation should be reported to the Ministry of Health (Vietnam Infrastructures and Medical Device Administration)./.
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PP. MINISTER
DEPUTY MINISTER (Signed and sealed) Do Xuan Tuyen (This translation is for reference only)
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