For D-class medical devices in Vietnam, which are considered high-risk, the registration process with the Vietnam Ministry of Health (MOH) follows a structured path. Here’s a general outline of the steps:

1. Product Classification

• Confirm that the device is classified as D-class (high-risk) under the Vietnamese medical device regulations. The classification is based on factors like the intended use, risks, and device characteristics.

2. Appoint a Local Authorized Representative

• If you're a foreign manufacturer, you'll need to appoint a local authorized representative in Vietnam to handle the registration process on your behalf.

3. Prepare the Required Documents

You’ll need to submit various documents, including:

• Application form (official form provided by the Ministry)
• Product technical dossier: This should include comprehensive information on the device, such as product description, intended use, design, manufacturing process, clinical data (if applicable), risk analysis, and post-market surveillance plan.
• Certificate of Free Sale (CFS) from the country of origin
• Good Manufacturing Practice (GMP) certificate for the manufacturer
• Declaration of Conformity or other equivalent documents proving compliance with applicable standards (e.g., ISO 13485, IEC 60601, etc.)
• Clinical trial data (if required)
• Labeling and Instructions for Use (in Vietnamese or English with a translation)
• Valid import license (if the product is imported)

4. Submit the Dossier to Vietnam MOH

• Submit all the documents to the Medical Device Administration Department (MDA) of the Vietnam MOH for review and evaluation.

5. Review and Approval Process

• The MOH will review the submission and may request additional information or clarification. The review process for high-risk devices can take several months.
• After a successful review, the MOH will issue the Medical Device Registration Certificate.

6. Post-Approval Requirements

• After registration, manufacturers and importers are required to comply with post-market surveillance, adverse event reporting, and quality control monitoring. Regular audits and inspections by the MOH may occur.

7. Renewal

• The registration for D-class devices typically lasts for 5 years. You’ll need to apply for renewal before it expires by submitting updated documentation as required.

It’s essential to work closely with a local consultant or authorized representative who understands the regulatory environment and can guide you through the process efficiently.

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