Key Considerations After Obtaining Class C Medical Device Registration with Vietnam MOH

Once your Class C medical device registration is approved by Vietnam’s Ministry of Health (MOH), you must comply with post-market requirements to maintain the validity of your registration and ensure legal market entry.

1. Post-Market Surveillance (PMS) & Compliance Requirements

✅ Adverse Event & Incident Reporting

• If any malfunction, serious injury, or death occurs related to your device, it must be reported to MOH.

• Reports must be submitted within:

  • 24 hours for severe incidents.

  • 30 days for less critical safety concerns.

✅ Product Quality Monitoring

• Ensure compliance with product safety, performance, and labeling requirements.

• Maintain a complaint handling system to track customer feedback and issues.

✅ Product Recall & Corrective Actions

• If a product defect or regulatory non-compliance is identified, a recall or corrective action must be reported to MOH.

2. Importation & Distribution Management

✅ Registration Validity & Renewal

• Class C registration certificates are valid indefinitely (as per Decree 98/2021/ND-CP).

• However, if the device design, intended use, or manufacturing process changes, a new registration may be required.

✅ Labeling & IFU Compliance

• Ensure all medical devices comply with Vietnam’s labeling regulations, including:

  • Product name and model.

  • Manufacturer and importer information.

  • Expiry date (if applicable).

  • Instructions for use in Vietnamese.

✅ Legal Representative Responsibilities

• Your Local Authorized Representative (LAR) must maintain MOH compliance and facilitate audits or inspections if required.

3. MOH Inspections & Audits

✅ Regulatory Inspections

• MOH may conduct random inspections of Class C devices in the market.

• Maintain proper records of imports, complaints, and corrective actions.

✅ Technical Documentation Updates

• If international standards change (e.g., ISO, IEC), update your compliance documents accordingly.

4. Business Expansion & Modifications

✅ New Models or Variants

• If you introduce a new model or variant under the same family, additional registration may be required.

✅ Manufacturer or Distributor Changes

• Notify MOH immediately if there is a change in manufacturer, local distributor, or LAR.

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