Does Class C Medical Device Registration with Vietnam MOH Require Annual Renewal?

No, Class C medical device registration with Vietnam MOH does not require annual renewal.

1. Registration Validity

📌 Under Decree No. 98/2021/ND-CP, medical device registration numbers for Class C devices are valid indefinitely unless there are significant changes to the device or regulatory requirements.

✅ No need for annual renewal once the registration is approved.

2. When is Renewal or Modification Required?

Even though registration does not expire, an update or re-application is required in cases of:

🔹 Changes in Manufacturer Information – If the company name, address, or ownership changes.
🔹 Device Design or Technical Modifications – If the device's specifications, intended use, or key components change.
🔹 Regulatory Updates – If Vietnam MOH introduces new compliance requirements.
🔹 Transfer of Registration Holder – If the Local Authorized Representative (LAR) changes.

In these cases, the manufacturer or Local Authorized Representative must submit an updated application to Vietnam MOH.

3. Post-Market Compliance Requirements

Even though renewal is not required, the registered product must comply with:
✅ Post-Market Surveillance (PMS) – Regular monitoring of device performance and reporting of safety issues.
✅ Adverse Event Reporting – Reporting any device-related incidents to MOH.
✅ Product Recalls or Corrective Actions – If safety concerns arise.

Conclusion

🔹 Class C medical device registration is valid indefinitely after approval.
🔹 No annual renewal is required, but updates must be submitted if there are significant changes.
🔹 Post-market compliance is mandatory to maintain market approval.

Would you like help with post-market compliance, regulatory updates, or document preparation?

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