The Vietnamese Ministry of Health (MOH) released Circular 33/2020/TT-BYT on 31st December 2020 which regulated for updating the list of medical devices that require safety testing and technical inspection.
The list of medical devices that must undergo safety testing and technical inspection has been updated to include the following:
- Breathing machines
- Anaesthetic breathing machines
- Electric scalpels
- Infant incubators
- Defibrillators
- Haemodialysis machines.
The Ministry of Health is responsible for reviewing and supplementing the list of other Class B, C, and D medical devices which are subject to technical and safety inspection.
Medical establishments shall organize testing of the safety and technical properties of medical equipment according to the implementation schedule in Article 4 of the Circular as follows:
– For breathing machines, anaesthetic breathing machines and electric scalpels:
- If procured on or following 1st September 2021, establishments must conduct safety and technical inspection as prescribed by the Minister of Health.
- If procured before 1st September 2021, establishments must conduct inspection before 31st December 2022.
– For Infant incubators, defibrillators and haemodialysis machines:
- If procured on or following 1st September 2022, establishments must conduct safety and technical inspection as prescribed by the Minister of Health.
- If procured before 1st September 2022, establishments must conduct inspection before 31st December 2023.
Medical devices testing establishments are responsible for examining the safety and technical features of medical equipment according to the inspection process promulgated by the Minister of Health.
The MOH is responsible for reviewing and amending the list of other Class B, C and D medical devices which are subject to mandatory annual safety and technical inspections. This list may be updated at any time. And please note that the Ministry of Health may conduct audits of safety and technical inspections at any time.
The circular comes into effect on the 1st March 2021.
If you would like more information or are interested in registering your medical device in Vietnam please send us an email to contact@andamanmed.com