Periodic Renewal Standards and Procedures for Class C Medical Device Registration with Vietnam MOH

As per Decree 98/2021/ND-CP, Class C medical device registration in Vietnam is valid indefinitely unless there are changes to the device or regulatory updates that require re-evaluation. However, companies must comply with post-market obligations, reporting requirements, and potential re-registration conditions in certain cases.

1. Renewal Standards for Class C Medical Devices

While a formal periodic renewal process is not required, you must ensure:
✅ Continued Compliance with Vietnam MOH regulations and relevant ISO/IEC standards.
✅ Valid Legal Documents, such as:

• Updated Certificate of Free Sale (CFS) from the country of origin.

• Updated ISO 13485:2016 Quality Management System certification.
  ✅ Post-Market Surveillance (PMS) Reports showing the device remains safe and effective.
  ✅ MOH Compliance Updates if new regulations affect your device classification.

2. When Re-Registration is Required?

Re-registration is necessary if:
🔹 Significant Changes to the Device Occur, such as:

• New design, materials, or manufacturing process.

• New intended use or indications.

• Additional models or variants not covered under the original registration.

🔹 Manufacturer or Local Authorized Representative (LAR) Changes

• If the manufacturer’s name, ownership, or location changes.

• If the Vietnam-based LAR changes, a new authorization must be submitted.

🔹 MOH Issues New Regulations Requiring Updated Registration

• If Vietnam adopts new ASEAN, ISO, or IEC standards affecting compliance.

3. Procedures for Updating or Re-Registering Class C Medical Devices

📌 Step 1: Prepare Required Documents

• ✅ Updated Certificate of Free Sale (CFS) (Legalized).

• ✅ Valid ISO 13485:2016 Certificate.

• ✅ Updated Declaration of Conformity.

• ✅ New technical files (if applicable, due to modifications).

📌 Step 2: Submit to MOH via DMEC Online System

• Log in to the MOH DMEC Portal.

• Upload updated documents for review.

• Pay applicable processing fees.

📌 Step 3: MOH Review & Approval

• Standard processing time: 30–90 days (subject to MOH evaluation).

• If additional clarifications are needed, MOH may request supplementary documents.

4. Key Compliance Reminders

✅ Maintain a Valid Local Authorized Representative (LAR)
✅ Comply with Post-Market Surveillance (PMS) and Reporting Obligations
✅ Stay Updated on Regulatory Changes from Vietnam MOH

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