Registration Period for Class C Medical Devices with Vietnam MOH

In Vietnam, the registration period for Class C medical devices includes the processing time for approval and the validity period of the registration.

1. Processing Time for Registration

The time required for the Vietnam Ministry of Health (MOH) to process a Class C medical device registration depends on the completeness of the application and MOH’s review workload.

📌 Estimated Processing Time:

• 10–90 days (MOH review and approval).

• Additional time may be required if MOH requests further information.

2. Validity of the Registration Certificate

Once approved, the registration number for Class C medical devices is valid indefinitely (no expiration date), as per Decree No. 98/2021/ND-CP.

✅ No renewal is required unless there are significant changes to the device, such as:

• Manufacturer changes.

• Device design modifications.

• Intended use alterations.

• Safety or performance updates.

3. Post-Approval Compliance Period

After obtaining the registration, manufacturers and importers must comply with post-market surveillance (PMS) regulations, including:
✅ Adverse event reporting.
✅ Product recalls or safety updates.
✅ Annual reporting requirements (if applicable).

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