Regulations and Requirements After Obtaining Class C Medical Device Registration with Vietnam MOH

Once a Class C medical device is successfully registered with Vietnam’s Ministry of Health (MOH), the manufacturer and local authorized representative (LAR) must comply with post-market surveillance (PMS), reporting obligations, and regulatory maintenance to keep the registration valid.

1. Compliance with Post-Market Surveillance (PMS) Regulations

Vietnam MOH requires manufacturers and importers to monitor the safety, quality, and performance of their medical devices after market approval.

✅ Adverse Event Reporting

• Any serious incident related to the device must be reported via the MOH DMEC system.

• Reporting timelines:

  • 24 hours for life-threatening incidents.

  • 30 days for less severe safety issues.

✅ Quality & Safety Monitoring

• Maintain records of complaints, recalls, and corrective actions.

• Implement a post-market surveillance (PMS) plan in compliance with ISO 14971 (Risk Management).

✅ Product Recall & Corrective Actions

• If a defect or safety concern arises, the company must submit a Corrective and Preventive Action (CAPA) report to MOH.

• Follow MOH recall procedures for affected devices.

2. Labeling & Distribution Compliance

✅ Labeling Requirements

• All products must comply with Vietnamese labeling regulations, including:

  • Product name and model.

  • Manufacturer and importer details.

  • Expiry date (if applicable).

  • Instructions for Use (Vietnamese translation required).

✅ Distribution & Importation Control

• The importer must be registered with MOH and maintain compliance.

• Ensure consistent device quality with approved registration details.

3. Validity & Registration Maintenance

✅ Registration Validity

• As per Decree 98/2021/ND-CP, Class C medical device registration is valid indefinitely.

• However, updates may be required if the device undergoes:

  • Design or manufacturing changes.

  • Regulatory updates impacting compliance.

✅ Changes & Modifications

• Notify MOH if there are changes in:

  • Manufacturer information.

  • Device specifications.

  • Local authorized representative (LAR).

4. MOH Inspections & Market Surveillance

✅ Regulatory Inspections

• MOH may conduct random inspections on registered devices in the market.

• Ensure all compliance documents, safety reports, and import records are available.

✅ Document Updates

• Maintain updated technical files, risk assessments, and clinical evaluations.

• Follow any new regulatory changes issued by MOH.

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