Vietnam: New Process for the Registration Application of Class C and D Medical Devices

New Process for the Registration Application of Class C and D Medical Devices in Vietnam

The Vietnam Ministry of Health posted on the DMEC website on the 10th of October 2023 regarding the new reception and registration process of Class C & D medical devices. Accordingly, the pre-assessment process for Class C and D applications has started since 10 October 2023.  

The following are the four steps of the new process:

  • Step 1: Enterprise shall create and submit documents to the Infrastructure and Medical Device Administration (IMDA). Once submitted, the application status will be indicated as “Application waiting for reception by the One-Stop Department”.
  • Step 2: Once the One-Stop Department has reviewed and received the application, the status will change to “Application is waiting for Enterprise to pay fees”. In case the dossier is not complete, the status will be indicated as ” Application is waiting for the Enterprise to supplement and complete”.
  • Step 3: Enterprises shall pay the fee and attach the receipt. Once the payment receipt is submitted, the status will be changed to “Application is waiting for the Department’s accounting to confirm fees”.
  • Step 4: The accountant of the Department of Infrastructure and Medical Equipment will confirm the application fee. The dossier will be transferred to the next processing steps as mentioned in the QT. TBCT. 15 that was attached with the Decision No. 2497/QĐ-BYT dated 12 September 2022, entitled “Process of Receipt, Evaluation, Issuance, Post-Check, and Recall of the Medical Device Circulation”.

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