The process to obtain D-class medical device registration with the Vietnam Ministry of Health (MOH) typically takes between 6 to 12 months. However, the exact timeline can vary depending on several factors, including the completeness of the application, the complexity of the device, and whether the MOH requires additional documentation or an on-site inspection.

Breakdown of the Typical Timeline:

1. Document Preparation (1-3 months):

   • Preparing the necessary documents, including clinical evaluation reports, risk management documentation, quality certifications (e.g., ISO 13485), and other product-specific data, can take 1 to 3 months depending on the complexity of the device and the availability of data.

2. Submission to the Drug Administration of Vietnam (DAV) (1-2 months):

   • After preparing the documents, the application is submitted to the Drug Administration of Vietnam (DAV). The DAV will review the completeness of the documents, which could take 1 to 2 months. If the application is incomplete, this phase could be extended.

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

   • The Vietnam MOH will then carry out a detailed evaluation of the device's safety and performance, reviewing clinical data, risk management plans, quality certifications, and compliance with relevant regulations.
   • For D-class devices, which are high-risk, the review process may be more stringent, possibly requiring an on-site inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).
   • This phase can take anywhere from 3 to 6 months, depending on the device’s complexity and the responsiveness of the manufacturer.

4. Approval and Issuance of Registration Certificate (1 month):

   • Once the MOH has completed its review, they will issue the registration certificate for the device. This stage generally takes around 1 month, assuming there are no delays.

Factors Affecting the Timeline:

• Completeness of the Application: If the application is incomplete or requires additional information, it could delay the process.
• On-Site Inspection: D-class devices, being high-risk, may require an on-site inspection of the manufacturing facility, which could extend the overall timeline.
• Additional Documentation or Clarifications: The MOH may request additional documents or clarifications, which could further extend the time required for registration.
• MOH's Workload: The MOH’s workload and the number of applications being processed at the time can also affect how long the review process takes.

In Summary:

• Total time for D-class medical device registration with the Vietnam MOH is typically between 6 to 12 months, with the exact duration depending on the device’s complexity, the completeness of the application, and the review process.

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