Conditions for Applying for Class C Medical Device Registration with Vietnam MOH

To apply for Class C medical device registration with Vietnam’s Ministry of Health (MOH), you must meet several legal, technical, and regulatory conditions. These conditions ensure compliance with Circular 39/2016/TT-BYT, which follows the ASEAN Medical Device Directive (AMDD).

1. Legal & Regulatory Conditions

✅ Local Authorized Representative (LAR) Requirement

• Foreign manufacturers must appoint a Vietnam-based LAR to handle the registration.

• The LAR must be legally registered in Vietnam and have a valid Medical Device Trading License.

• The LAR is responsible for post-market surveillance and adverse event reporting.

✅ Device Classification as Class C

• The medical device must be classified as Class C based on MOH guidelines.

• Classification follows ASEAN AMDD risk classification criteria (moderate-to-high risk devices).

✅ Certificate of Free Sale (CFS) or Market Authorization

• The device must have market authorization in its country of origin or from a recognized regulatory body (e.g., FDA, CE, TGA).

• The CFS must be legalized and notarized.

✅ ISO 13485 Certification

• The manufacturer must have a valid ISO 13485 Quality Management System (QMS) certificate.

• The certificate must be notarized.

2. Technical & Documentation Conditions

✅ Complete Registration Dossier
A full set of documents must be prepared, including:

• Device Description & Intended Use

• Risk Classification Justification

• Instructions for Use (IFU) in Vietnamese

• Labeling & Packaging (must comply with Vietnam’s regulations)

• Clinical Evaluation Report (CER) for certain Class C devices

• Test Reports & Safety Compliance (if applicable)

• Declaration of Conformity (manufacturer’s compliance statement)

• Post-Market Surveillance (PMS) Plan

✅ Compliance with Vietnamese Standards

• The device must meet applicable ISO/IEC standards.

• Electrical devices must comply with IEC 60601 (if applicable).

✅ Online Submission via MOH DMEC Portal

• The application must be submitted electronically at https://dmec.moh.gov.vn.

• Only the LAR can access the portal and submit the application.

3. Post-Registration Obligations

Once approved, the Marketing Authorization (MA) certificate allows the sale of the device in Vietnam. The manufacturer/LAR must:

• Ensure compliance with post-market surveillance (PMS) regulations.

• Report adverse events, recalls, or safety issues.

• Renew the registration before its expiry.

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