Registering a Class C medical device with the Vietnam Ministry of Health (MOH) involves the following steps:

1. Determine the Classification

Ensure your device is classified as Class C based on Circular 39/2016/TT-BYT, which follows ASEAN Medical Device Directive (AMDD) guidelines.

2. Appoint a Local Authorized Representative (LAR)

If you are a foreign manufacturer, you must appoint a Local Authorized Representative (LAR) in Vietnam. This representative is responsible for submitting the application and managing post-market activities.

3. Prepare Required Documents

You will need to submit a Certificate of Free Sale (CFS), technical documentation, and quality certifications. The main documents include:

• Legal Documents:

  • Business license of the importer

  • Letter of authorization from the manufacturer to the local representative

  • Certificate of Free Sale (CFS) or Market Authorization from a reference country (US FDA, CE, TGA, etc.)

  • ISO 13485 certificate

• Technical Documents:

  • Device description and intended use

  • Instruction for use (IFU)

  • Risk analysis and clinical evaluation (if applicable)

  • Test reports and proof of compliance with relevant standards

• Quality and Safety Compliance:

  • Declaration of conformity to relevant ISO and IEC standards

  • Clinical or preclinical data for high-risk Class C devices

4. Submit the Application to the MOH Portal

• Applications are submitted online through the Vietnam MOH’s Department of Medical Equipment and Construction (DMEC) portal.

• MOH reviews applications for completeness and compliance.

5. Registration Review and Approval

• Class C devices may require a technical dossier review by MOH experts, which can take several months.

• If approved, you will receive a Marketing Authorization (MA) number, valid indefinitely under the new regulatory framework.

6. Post-Market Surveillance

• Report adverse events and comply with MOH post-market surveillance requirements.

• Ensure proper labeling and translation into Vietnamese.

Processing Time

• Typically takes 3–6 months, depending on completeness and MOH workload.

Would you like assistance with any specific part of the process?

Contact Us：

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