Person carrying out audit and checking paperwork application

Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices

On 12 September 2022, the Vietnamese Ministry of Health issued the QT.TBCT.15 entitled “Procedures for Receiving, Appraising, Issuing, Post-Inspection, and Withdrawing the Circulation Number of The Medical Devices. The regulation applies to the evaluation of all registration routes of medical devices class C and D, and its post inspection with the case of fast-track and urgent registration approval and withdrawal of the circulation number.

The procedure is intended to guide the leader of the Ministry of Health, the experts of DMEC and other relevant departments of MOH, the assigned expert, the member of the consultant council granting the circulation number of the medical devices, and the organization or individual who joins the procedure of granting or withdrawing the medical device circulation number according to Decree 98/2021/NĐ-CP.

The contents of this regulation document are as follows:

  1. Details of the internal processes at the Ministry of Health.
  2. Supplementary procedure deadline and allowable number of supplementations.
  • The deadline for the supplement is around 90 days from the date of receiving the supplement request document from MOH.
  • The maximum of supplements is 5 times per application except for the case of the urgent route.
  • After 90 days or 5 times of supplement from the date of receiving the supplement request from MOH, if it still does not comply with the request, the applicants must re-submit the new registration application.
  1. The evaluation procedure flow chart of medical device class C and D with the following criteria:
  • Medical device that has the national standard;
  • The measurement device which requires the approval of the sample according to the measurement regulations;
  • Medical device submitted in the fast-track route and urgent route;
  • Other medical device class C and D.
  1. The post-inspection procedure of the medical device Class C and D which was granted the circulation number in the fast-track route and urgent route.
  2. The regulation of the number of experts who evaluated each medical device application.
  3. The description of the procedure of granting the circulation number of the medical device class C and D.
  4. The description of the procedure of withdrawing the circulation number of the medical device class C and D which was granted the circulation number in the fast-track route and urgent route.
  5. The summary of the documents required for the registration of medical device class C and D, and its registration fee.

If you have any queries, please get in touch or click the button below.

Sign up for our regulatory roundup delivered once a month to your inbox

Scroll to Top