The purpose of registering Class B medical devices with the Vietnam Ministry of Health (MOH) is to ensure that all medical devices entering the Vietnamese market are safe, effective, and of high quality, and to provide legal authorization for their import, distribution, and use in Vietnam.

🎯 Key Purposes of Registration

✅ 1. Protect Public Health and Safety

• Ensures that Class B devices (low to moderate risk) meet regulatory standards before being used on patients.

• Reduces risks related to faulty, counterfeit, or unapproved products.

✅ 2. Legal Market Authorization

• MOH registration gives a "product listing number" (số lưu hành).

• This number is mandatory for:

  • Importation

  • Customs clearance

  • Sales and distribution within Vietnam

✅ 3. Traceability and Market Surveillance

• Registered devices are entered into the MOH’s DMEC national database.

• This allows authorities to track product origin, check compliance, and conduct post-market inspections.

✅ 4. Harmonization with ASEAN Standards

• Aligns with the ASEAN Medical Device Directive (AMDD), promoting regional trade and regulatory consistency.

✅ 5. Encourages Compliance by Manufacturers

• Ensures that foreign manufacturers:

  • Appoint a local Authorized Representative (AR)

  • Follow Vietnamese labeling and documentation requirements

  • Maintain quality management systems (e.g., ISO 13485)

📌 In Summary

Would you like help explaining this purpose to a regulatory affairs team or in a business proposal? I can help you draft that clearly.

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