The cycle time for D-class medical device registration with the Vietnam Ministry of Health (MOH) generally takes 6 to 12 months, depending on the complexity of the device and the completeness of the application. However, several factors can affect the timeline, such as the responsiveness of the applicant, the thoroughness of the review process, and whether any additional information or clarifications are required by the Drug Administration of Vietnam (DAV).

Breakdown of the Registration Timeline:

1. Document Preparation (1-3 months):

   • Preparing the necessary documentation, including the clinical evaluation report (CER), risk management file, quality certifications (ISO 13485), test reports, and other required documents can take 1-3 months depending on the device and the availability of data.

2. Submission to the DAV (1-2 months):

   • After submission, the DAV will review the documents for completeness. If the application is incomplete or if the documents are not in the correct format, this phase may take longer.

3. Regulatory Review and Evaluation (3-6 months):

   • The Vietnam MOH will conduct a thorough evaluation of the submitted application, including reviewing clinical data, safety information, and other documentation.
   • For D-class devices, which are considered high-risk, the review may be more rigorous and could require an on-site inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).

4. Approval and Registration (1 month):

   • Once the DAV completes its review and is satisfied with the submission, the MOH will issue a registration certificate for the device. This process typically takes 1 month after all necessary approvals.

Total Time Estimate:

• Total cycle time: Typically, the entire process for D-class medical device registration can take anywhere from 6 to 12 months.

Factors That May Affect the Timeline:

• Completeness of the Application: If the application is incomplete or if the required documents are missing, it will take longer to review.
• Need for Additional Information: If the MOH requests additional documents or clarifications, this can add time to the process.
• On-site Inspection: For high-risk devices, an on-site inspection of the manufacturing facility may be required, which could further extend the timeline.
• Workload of the MOH: The MOH’s current workload, including the number of applications being processed, could also impact the review timeline.

To minimize delays, it is important to ensure that all required documentation is complete, accurate, and meets the MOH’s standards.

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