To apply for Class B medical device registration with the Ministry of Health (MOH) in Vietnam, you must follow the procedures outlined under Decree 98/2021/ND-CP (and its amendments, e.g., Decree 07/2023/ND-CP). Here's a step-by-step guide to help you understand and navigate the process:

✅ Step-by-Step Guide to Register Class B Medical Devices in Vietnam

1. Appoint a Local Authorized Representative (AR)

Foreign manufacturers must appoint a legal representative in Vietnam.

This representative is responsible for submitting the application and holding the registration license (MA – Market Authorization).

2. Determine Device Classification

Confirm your device is classified as Class B.

Classification must follow MOH rules or be validated by a certified Classification Organization in Vietnam.

3. Prepare Required Documents

Here’s a general list of required documents for Class B device registration:

Document

Details

1. Application Form (Form No. 01 - Annex I of Decree 98)    Signed by the AR    

2. Legal documents of the applicant    Business license, representative authorization letter    

3. Free Sale Certificate (FSC)    Issued by competent authority in the country of origin (notarized + legalized)    

4. Certificate of ISO 13485    For the manufacturer    

5. Product Technical File / Dossier    Includes product description, specifications, labeling, IFU, risk assessment, etc.    

6. Clinical evaluation or equivalent    Depending on the type of device    

7. Labeling and Instructions for Use    Must include Vietnamese translations    

8. Proof of classification result    From a certified classification body (if needed)    

4. Submit the Application

Submission is done via the Vietnam Medical Device Management Portal: 🌐 https://dmec.moh.gov.vn/

5. Review Process

For Class B, the registration process is a notification-based process (not a full evaluation as in Class C/D).

If documents are complete and meet requirements, the Notification of Listing Number will be issued.

Timeframe: Typically 5–10 working days if all documents are correct.

6. Receive Listing Number (Số lưu hành)

This listing number serves as the market authorization for your device.

It remains valid indefinitely, unless the device is recalled, withdrawn, or the AR changes.

⚠️ Important Notes:

Language: Most documents must be submitted in Vietnamese or be translated and legalized as required.

Post-market surveillance: The AR is responsible for post-market obligations such as incident reporting and product recalls.

Labeling: All labels and instructions must be in Vietnamese before commercialization.

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