Before applying for Class B medical device registration with the Vietnam Ministry of Health (MOH), it's crucial to prepare thoroughly to ensure a smooth and successful application process. Below are the key preparations you should make in advance:

✅ 1. Determine the Correct Classification

• Confirm that your device is Class B according to Vietnam’s risk-based classification system (aligned with ASEAN/GHTF rules).

• You may consult a licensed classification agency in Vietnam for an official classification result, although not mandatory.

✅ 2. Choose an Authorized Representative (AR) in Vietnam

• Foreign manufacturers must appoint a local AR to submit and manage the registration.

• The AR must have:

  • A business license covering medical device trading

  • Staff with appropriate qualifications (biomedical, pharmacy, etc.)

  • A physical address in Vietnam

✅ 3. Prepare Legal and Administrative Documents

These documents must be notarized, legalized (consularized), and translated into Vietnamese:

• Certificate of Free Sale (FSC) or equivalent

• Letter of Authorization (LOA) appointing the Vietnam AR

• ISO 13485 certificate of the manufacturer

• Business license of the AR in Vietnam

✅ 4. Compile the Technical Documentation

Prepare a technical dossier that includes:

• Device description & intended use

• Technical specifications

• Risk management report (ISO 14971)

• Test reports (e.g. biocompatibility, EMC, safety)

• Labels and IFU in Vietnamese

• Quality control procedures

• Manufacturing information

➡️ Must align with the format required under Decree 98/2021/ND-CP and Circular 05/2022/TT-BYT

✅ 5. Translate Key Documents into Vietnamese

Documents that must be in Vietnamese:

• Label and packaging information

• Instructions for Use (IFU)

• Summary of product description

• Legal documents (after legalization)

• Classification statement (if available)

✅ 6. Check Importer & Distribution Readiness

• Ensure your importer or AR can:

  • Handle customs clearance

  • Maintain traceability records

  • Conduct post-market surveillance (PMS)

  • Respond to adverse events or MOH inquiries

✅ 7. Check Standard Compliance and Test Reports

• Make sure your product complies with recognized international standards, such as:

  • ISO 13485

  • ISO 14971

  • ISO 10993 (biocompatibility)

  • IEC 60601 (for electrical devices)

• Prepare test reports and certificates from accredited labs

✅ 8. Prepare a Vietnamese Label Template

• Include the following:

  • Device name and model

  • Manufacturer name and country

  • Authorized Representative details

  • Listing number (once approved)

  • Lot number, expiration date (if applicable)

✅ 9. Stay Up to Date with MOH Regulations

• Follow updates to Decree 98/2021/ND-CP and related circulars.

• Watch for implementation changes or digital platform updates for registration.

📌 Summary Checklist for Pre-Registration Preparation

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