How to Apply for Class C Medical Device Registration with Vietnam MOH?

To register a Class C medical device in Vietnam, you must submit an application to the Ministry of Health (MOH) - Department of Medical Equipment and Construction (DMEC). The registration follows Circular 39/2016/TT-BYT, in line with the ASEAN Medical Device Directive (AMDD).

1. Where to Apply?

Online Submission Portal:
🔗 Vietnam MOH DMEC Portal

• All applications must be submitted online via this portal.

• Only a Local Authorized Representative (LAR) can submit the application.

• The portal allows applicants to track the registration status.

2. Step-by-Step Application Process

Step 1: Appoint a Local Authorized Representative (LAR)

✅ Foreign manufacturers must appoint a Vietnam-based company to handle the registration.
✅ The LAR must be licensed and registered with the MOH.

Step 2: Prepare the Registration Dossier

📌 Documents required:

1. Application Form – Completed and signed by the LAR.

2. Letter of Authorization (LOA) – Legalized document authorizing the LAR.

3. Certificate of Free Sale (CFS) – Issued by the country of origin or a recognized regulatory body (FDA, CE, TGA, etc.), legalized.

4. ISO 13485 Certificate – Manufacturer’s Quality Management System, notarized.

5. Device Description – Technical specifications, model details, intended use.

6. Risk Classification Justification – Explaining why the device is classified as Class C.

7. Instructions for Use (IFU) – Translated into Vietnamese.

8. Labeling & Packaging Information – Must comply with Vietnamese labeling regulations.

9. Clinical Evaluation Report (CER) – Required for some Class C devices.

10. Test Reports & Safety Compliance – Performance and safety tests, if applicable.

11. Declaration of Conformity – Manufacturer’s statement of compliance with regulations.

12. Post-Market Surveillance (PMS) Plan – Monitoring and adverse event reporting strategy.

📌 All foreign documents must be notarized and legalized before submission.

Step 3: Submit the Application via DMEC Portal

✅ Log in to DMEC MOH Portal using the LAR’s account.
✅ Upload the complete registration dossier in PDF format.
✅ Pay the registration fee of VND 6 million (approx. USD 240).

Step 4: MOH Review & Approval

✅ MOH reviews the application within 10 to 90 days (delays up to 1 year are possible).
✅ If additional information is required, the LAR must respond to MOH requests.
✅ Once approved, MOH issues a Marketing Authorization (MA) certificate, allowing the product to be legally sold in Vietnam.

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