Regulatory Affairs Update Vietnam

Vietnam: Ministry Of Health Appoints The Units To Appraise The Common Submission Dossier Template (CSDT) According To ASEAN Regulations

On 02 January 2024, the Vietnam Ministry of Health issued Decision No. 04/QD-BYT which elaborated that the appraisal of the submitted CSDT (Common Submission Dossier Template) for the purpose of medical device registration, will be conducted by the appointed third-party agencies as follows:

  • For non-in vitro medical devices: Institute of Medical Equipment and Construction.
  • For in vitro medical devices: National Institute for Control of Vaccine and Biologicals.

The above-mentioned agencies are responsible for coordinating with the Infrastructure and Medical Device Administration or IMDA (previously called DMEC), in the processing of applications for medical device and keeping CSDT records according to regulations. The above-mentioned agencies shall provide reports to the IMDA on the results of the appraisal of CSDT every 6 months and 1 year. This decision takes effect starting January 2, 2024.

Further information can be accessed here (in Vietnamese).

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