Official Dispatch No. 8329/BYT-HTTP: inspecting and reviewing the procedures for declaring medical devices

On December 30, 2023, the Ministry of Health issued Official Dispatch No. 8329/BYT-HTTB inspecting and reviewing the procedures for declaring medical devices, give Health Departments to promptly carry out the following tasks.

– Conduct a review of the declarations of medical  on the System at https://dmec.moh.gov.vn in accordance with regulations and relevant documents (Emphasize reviewing the results of medical  classification to ensure compliance with regulations on the classification of medical device).

– Verify the legality and accuracy of the documents submitted in the dossier and ensure that the documents in the dossier remain valid throughout the implementation process. Additionally, take responsibility for preserving the documents in the dossier as required.

Readers can download the content below:

– English Version: https://medgate.vn/wp-content/uploads/2023/12/EN_-Cong-van-8329-BYT-1.pdf