Requirements for Class C Medical Device Registration with Vietnam MOH

Class C medical devices are considered moderate-to-high risk and must comply with Vietnam’s Ministry of Health (MOH) regulations, particularly Circular 39/2016/TT-BYT under the ASEAN Medical Device Directive (AMDD). Below are the key requirements for registration:

1. Appoint a Local Authorized Representative (LAR)

If the manufacturer is not based in Vietnam, a Local Authorized Representative (LAR) must be appointed.

• The LAR must be a legally registered company in Vietnam with authorization to distribute medical devices.

• The LAR will submit the application, communicate with MOH, and ensure post-market compliance.

2. Required Documents for Registration

A. Legal & Administrative Documents

✅ Application Form – Filled and signed by the LAR.
✅ Letter of Authorization (LOA) – From the manufacturer to the LAR.
✅ Certificate of Free Sale (CFS) or Market Authorization – Issued by the country of origin or recognized regulatory authorities (e.g., FDA, CE, TGA).
✅ ISO 13485 Certificate – Proof of Quality Management System (QMS) compliance.

B. Technical Documentation

✅ Device Description – Including name, model, intended use, and working principle.
✅ Risk Classification Justification – Explaining why the device is classified as Class C according to Vietnam’s classification rules.
✅ Instructions for Use (IFU) – Must be translated into Vietnamese.
✅ Labeling Information – Must comply with Vietnamese regulations (Vietnamese language required).
✅ Clinical Evaluation Report – Required for certain Class C devices.
✅ Test Reports – Performance and safety testing based on recognized standards (e.g., IEC, ISO).

C. Regulatory Compliance

✅ Declaration of Conformity – Compliance with ASEAN AMDD and relevant international standards.
✅ Post-Market Surveillance Plan – Outlining monitoring, adverse event reporting, and recall procedures.

3. Submission Process via DMEC Portal

• Submit the application and supporting documents online through the MOH DMEC portal: https://dmec.moh.gov.vn.

• Pay the registration fee as per MOH regulations.

4. MOH Review & Approval

• MOH will review the dossier for completeness and compliance.

• Technical evaluation may be required, depending on the device type.

• If approved, MOH will issue a Marketing Authorization (MA) number.

5. Post-Market Requirements

Once registered, the device must comply with:
✅ Post-market surveillance – Reporting of adverse events.
✅ Proper labeling and distribution requirements.
✅ Renewal or updates if any significant changes occur.