Process and Steps for Class C Medical Device Registration with Vietnam MOH

Class C medical devices are categorized as moderate-to-high risk and require a structured approval process under the Vietnam Ministry of Health (MOH). The Department of Medical Equipment and Construction (DMEC) oversees the registration process.

Step-by-Step Registration Process

1. Determine Classification

• Ensure the device is classified as Class C under Circular 39/2016/TT-BYT, which follows the ASEAN Medical Device Directive (AMDD).

• If needed, consult MOH or a regulatory expert for classification confirmation.

2. Appoint a Local Authorized Representative (LAR)

• Foreign manufacturers must appoint a Local Authorized Representative (LAR) in Vietnam.

• The LAR must be a legally registered company in Vietnam with a medical device trading license.

• The LAR will handle the application, communication with MOH, and post-market responsibilities.

3. Prepare the Required Dossier

The registration dossier must include legal, administrative, and technical documents.

A. Legal & Administrative Documents

• Application form (signed by the LAR)

• Letter of Authorization (LOA) from the manufacturer to the LAR

• Certificate of Free Sale (CFS) or equivalent from a recognized regulatory authority (FDA, CE, TGA, etc.)

• ISO 13485 certificate (Quality Management System for medical devices)

B. Technical Documentation

• Device description, intended use, and model specifications

• Instructions for Use (IFU) in Vietnamese

• Labeling (translated into Vietnamese)

• Risk classification justification

• Clinical evaluation data (if applicable)

• Testing reports (if required)

4. Submit the Application via DMEC Portal

• Submit the dossier online through the MOH DMEC portal: https://dmec.moh.gov.vn

• Pay the registration fee as per MOH regulations.

5. MOH Review & Approval Process

• Preliminary Review: MOH checks for completeness of documents.

• Technical Evaluation: MOH experts assess safety, effectiveness, and compliance.

• Approval Decision: If the submission is satisfactory, MOH grants Marketing Authorization (MA).

• Timeline: The approval process typically takes 3 to 6 months.

6. Receive the Registration Certificate

• Once approved, MOH issues a Marketing Authorization (MA) number.

• Under the new regulatory framework, Class C registrations are valid indefinitely unless revoked due to non-compliance.

7. Post-Market Surveillance & Compliance

• Adhere to MOH's post-market monitoring requirements.

• Report adverse events and any product recalls.

• Ensure compliance with Vietnamese labeling, safety, and distribution regulations.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn