The Ministry of Health has issued Circular No. 59/2025/TT-BYT amending Circular No. 05/2022/TT-BYT, which provides guidance on the implementation of certain provisions of Government Decree No. 98/2021/NĐ-CP on the management of medical devices.
The amendment specifically updates Article 8, which outlines the roadmap for safety and technical performance testing of medical devices listed in Article 5 of Circular No. 05/2022/TT-BYT.
Read the full circular here: See attached Vietnamese document (English translation not available). [PDF]
Purpose of the Amendment
- To update the roadmap for mandatory safety and technical performance testing of designated medical devices.
- To clarify the responsibilities of medical facilities in ensuring safe and compliant device operation.
- To ensure all applicable devices meet the safety and performance standards established by the Ministry of Health.
Scope of Application
The updated roadmap applies to the following medical devices:
- Ventilators
- Anesthesia machines with ventilators
- Electrosurgical knives
- Neonatal incubators
- Defibrillators
- Hemodialysis machines
Key Highlights
Updated Roadmap for Safety and Technical Performance Testing
Devices purchased after 30 June 2026
Medical facilities must ensure these devices undergo safety and technical performance testing in accordance with procedures issued by the Minister of Health.
Devices purchased before 1 July 2026
These devices may continue to be used provided that safety and technical performance testing is completed by December 31, 2026, following the Minister of Health’s procedures.
Medical facilities assume full legal responsibility for ensuring patient safety during use prior to completion of testing.
Responsibilities of Medical Facilities
- Conduct mandatory inspections of medical devices included in the scope of this regulation.
- Ensure proper management, maintenance, and operation of devices according to manufacturer instructions.
- Continuously monitor device quality and report any equipment that fails to meet required safety or performance standards.
Organizational Implementation
The Vietnam Infrastructure and Medical Device Administration (IMDA) will coordinate with relevant agencies to enforce this Circular and support the development of medical device inspection facilities.
Implications to Clients
Businesses should take note of these regulatory updates to ensure equipment procurement, installation, and continued use comply fully with the updated testing requirements.
Effective Date
31 December 2025
For Inquiries
For inquiries or support regarding regulatory requirements for medical devices in Vietnam, please contact sales@andamanmed.com.
