Standards for Class C Medical Device Registration with Vietnam MOH

Class C medical devices in Vietnam must comply with local and international standards as required by the Ministry of Health (MOH) - Department of Medical Equipment and Construction (DMEC). The registration follows Circular 39/2016/TT-BYT, which aligns with the ASEAN Medical Device Directive (AMDD).

1. Key Standards Applicable to Class C Medical Devices

A. Quality Management System (QMS) Standard

✅ ISO 13485:2016 – Mandatory for all medical device manufacturers.

B. Product Safety & Performance Standards

✅ Devices must comply with international or recognized national standards, including:

1. Electrical Medical Equipment:

• IEC 60601-1 – General safety requirements for medical electrical equipment.

• IEC 60601-1-2 – Electromagnetic compatibility (EMC).

2. Sterile & Disposable Medical Devices:

• ISO 11135 – Ethylene oxide sterilization.

• ISO 11137 – Radiation sterilization.

• ISO 10993 – Biocompatibility testing (for contact with human tissues).

3. In Vitro Diagnostic (IVD) Devices:

• ISO 15189 – Laboratory requirements for quality and competence.

• ISO 23640 – Stability testing of IVD reagents.

4. Implantable Medical Devices:

• ISO 14630 – General requirements for non-active implants.

• ISO 14708 – Standards for active implantable medical devices.

5. Software as a Medical Device (SaMD):

• IEC 62304 – Software lifecycle processes.

• ISO 14971 – Risk management for medical devices.

2. Additional Requirements for Class C Devices

✅ Certificate of Free Sale (CFS) – Legalized proof of approval in the country of origin or major regulatory bodies (FDA, CE, TGA, etc.).
✅ Clinical Evaluation Report (CER) – Required for certain devices based on risk classification.
✅ Risk Management & Post-Market Surveillance (PMS) Plan – Compliance with ISO 14971 and Vietnam’s post-market reporting regulations.

3. How to Ensure Compliance?

📌 Verify that your device meets IEC/ISO standards before submission.
📌 Conduct safety, biocompatibility, and EMC tests as per regulatory standards.
📌 Prepare test reports and documentation for submission via the MOH DMEC portal.

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