Class C Medical Device Registration with Vietnam MOH

Vietnam’s Ministry of Health (MOH) regulates Class C medical devices under Circular 39/2016/TT-BYT, aligned with the ASEAN Medical Device Directive (AMDD). Below is a complete guide on the procedures, required materials, and key considerations for registration.

1. Procedures for Class C Medical Device Registration

Step 1: Appoint a Local Authorized Representative (LAR)

• Foreign manufacturers must appoint a Vietnam-based LAR to submit the application.

• The LAR must be legally registered and licensed to distribute medical devices in Vietnam.

Step 2: Prepare Registration Dossier

A complete dossier must be submitted via the MOH DMEC online portal: https://dmec.moh.gov.vn.

A. Legal & Administrative Documents

✅ Application Form – Filled and signed by the LAR.
✅ Letter of Authorization (LOA) – Authorizing the LAR to act on behalf of the manufacturer.
✅ Certificate of Free Sale (CFS) – From the country of origin or a recognized regulatory authority (FDA, CE, TGA, etc.).
✅ ISO 13485 Certificate – Proof of the manufacturer’s Quality Management System (QMS).

B. Technical Documentation

✅ Device Description – Including model, specifications, and intended use.
✅ Risk Classification Justification – Explaining why the device is classified as Class C under MOH rules.
✅ Instructions for Use (IFU) – Must be translated into Vietnamese.
✅ Labeling Information – Must comply with Vietnamese labeling regulations.
✅ Clinical Evaluation Report – Required for some Class C devices.
✅ Testing Reports – Based on relevant ISO/IEC standards (if applicable).

Step 3: Submit Application via DMEC Portal

• Log in to DMEC MOH Portal and submit the dossier.

• Pay the registration fee of VND 6 million (approx. USD 240).

• MOH will review the submission within 10 to 90 days (delays up to one year are possible).

Step 4: MOH Review & Approval

• MOH evaluates the completeness and accuracy of the dossier.

• If approved, MOH grants a Marketing Authorization (MA) certificate.

• If rejected, the applicant must revise and resubmit as per MOH feedback.

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