Materials Needed for Class C Medical Device Registration with Vietnam MOH

Class C medical device registration with Vietnam’s Ministry of Health (MOH) follows the requirements outlined in Circular 39/2016/TT-BYT, which aligns with the ASEAN Medical Device Directive (AMDD). Below is a detailed list of required materials and how to prepare the application documents.

1. Required Materials for Registration

A. Legal & Administrative Documents

✅ Application Form

• Completed and signed by the Local Authorized Representative (LAR).

• Must be in Vietnamese.

✅ Letter of Authorization (LOA)

• Issued by the manufacturer to authorize the LAR to submit the application.

• Must be notarized and legalized (e.g., by an embassy or consulate).

✅ Certificate of Free Sale (CFS) or Market Authorization

• Issued by the country of origin or a recognized regulatory authority (FDA, CE, TGA, etc.).

• Must be notarized and legalized.

✅ ISO 13485 Certificate

• Valid Quality Management System (QMS) certificate for the manufacturer.

• Must be notarized.

B. Technical Documentation

✅ Device Description & Specifications

• Product name, model, classification, intended use, and working principles.

• Comparison with similar devices (if applicable).

✅ Risk Classification Justification

• Explanation of why the device is classified as Class C according to Vietnam’s MOH rules.

✅ Instructions for Use (IFU)

• Must be translated into Vietnamese.

✅ Labeling & Packaging Information

• Must comply with Vietnamese medical device labeling regulations.

• Labels must be in Vietnamese and include:

  • Product name

  • Manufacturer details

  • Importer details

  • Expiry date

  • Warnings & precautions

✅ Clinical Evaluation Report (CER)

• Required for certain Class C devices.

• Can be based on clinical trials, literature review, or equivalent device approvals.

✅ Test Reports & Safety Standards Compliance

• Performance and electrical/mechanical safety test reports (if applicable).

• Compliance with ISO/IEC standards.

✅ Declaration of Conformity

• A manufacturer’s statement ensuring compliance with regulatory requirements.

✅ Post-Market Surveillance (PMS) Plan

• Outlines monitoring, reporting of adverse events, and recall procedures.

2. How to Prepare the Application Documents?

Step 1: Collect & Authenticate Legal Documents

• Ensure CFS, ISO 13485, and LOA are notarized and legalized.

• Legalization may require consular authentication (e.g., at an embassy).

Step 2: Translate Documents into Vietnamese

• Documents such as IFU, risk classification, and labeling must be translated.

• Use a certified translator to ensure compliance.

Step 3: Prepare a Complete Dossier

• Organize documents as per MOH's required format.

• Ensure all forms are signed, stamped, and dated properly.

Step 4: Submit Online via DMEC Portal

🔗 https://dmec.moh.gov.vn

• The Local Authorized Representative (LAR) must submit the dossier.

• Pay the registration fee (VND 6 million / ~USD 240).

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