Class C Medical Device Registration with Vietnam MOH

In Vietnam, medical devices are classified into Class A, B, C, and D based on risk level, following the ASEAN Medical Device Directive (AMDD). Class C medical devices are moderate-to-high-risk devices, requiring more stringent regulatory control than Class A or B but less than Class D.

How to Apply for Class C Medical Device Registration in Vietnam?

1. Determine Device Classification

Confirm your medical device falls under Class C according to Circular 39/2016/TT-BYT issued by the Ministry of Health (MOH), Vietnam.

2. Appoint a Local Authorized Representative (LAR)

Foreign manufacturers must appoint a Local Authorized Representative (LAR) in Vietnam, who will handle the registration and post-market surveillance.

3. Prepare the Required Documents

You must submit a registration dossier that includes the following:

A. Legal and Administrative Documents

• Application form (signed by the local representative)

• Letter of Authorization from the manufacturer to the local representative

• Certificate of Free Sale (CFS) or equivalent (from the country of origin or a recognized regulatory authority like FDA, CE, TGA)

• ISO 13485 certificate (Quality Management System)

B. Technical Documentation

• Device description and intended use

• Labeling and Instructions for Use (Vietnamese translation required)

• Risk analysis report and summary of safety/performance

• Clinical evaluation report (if applicable)

• Test reports (if required)

4. Submit the Application to Vietnam MOH (DMEC Portal)

• Applications must be submitted online via the Department of Medical Equipment and Construction (DMEC) Portal: https://dmec.moh.gov.vn

• Pay the registration fee

5. Review and Approval by MOH

• MOH reviews Class C applications more strictly than Class A or B.

• The approval process may take 3 to 6 months, depending on MOH’s workload and completeness of the application.

6. Receive Registration Approval

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

• The new regulatory framework grants indefinite validity for Class C medical device registrations.

7. Post-Market Compliance

• Follow MOH’s post-market surveillance requirements.

• Report adverse events and maintain compliance with Vietnamese regulations.

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