What is Class B Medical Device Registration with the Vietnam MOH?

In Vietnam, medical devices are classified into four risk classes:

Class A – Low risk

Class B – Low to moderate risk

Class C – Moderate to high risk

Class D – High risk

Class B medical devices include general diagnostic and monitoring equipment, surgical instruments, certain infusion sets, wound care products, etc.
These are not life-supporting, but still require compliance with certain technical and safety standards.

✅ How to Apply for Class B Medical Device Registration in Vietnam

The process follows Decree 98/2021/ND-CP and its update Decree 07/2023/ND-CP. Here’s a simplified guide:

📝 Step-by-Step Application Process

1. Appoint a Local Authorized Representative (AR)

Foreign manufacturers must appoint a company in Vietnam to act as the registration holder.

The AR submits the application and is legally responsible for the device in Vietnam.

2. Classify the Device as Class B

Use official classification rules under Circular 05/2022/TT-BYT.

Optionally, use a licensed classification organization in Vietnam to issue a classification result.

3. Prepare Required Documents

You’ll need:

No.

Document

Notes

1    Application form (Form 01, Annex I)    Signed by the AR    

2    Business license of the AR    Proof of legal operation in Vietnam    

3    Authorization letter from the manufacturer    Legalized & notarized    

4    Free Sale Certificate (FSC)    Issued by competent authority in the country of origin    

5    ISO 13485 certificate    Manufacturer’s QMS certification    

6    Product Dossier    Including technical specs, user manuals, risk analysis    

7    Label and IFU in Vietnamese    Must comply with local labeling regulations    

8    Classification result    Optional, but helpful if issued by a local certifying body    

4. Submit Online via MOH Portal

Portal: https://dmec.moh.gov.vn

Create an account, upload all documents, and submit the application.

**5. Get the “Listing Number” (Số lưu hành)

For Class B devices, registration is notification-based.

If documentation is sufficient, the system will generate a listing number automatically.

Usually issued within 5–10 working days.

✅ After Registration

The listing number is valid indefinitely (no expiry).

Must notify MOH of any changes to product, labeling, or AR.

Ensure compliance with post-market obligations.

💡 Need help?

I can help you prepare:

A full document checklist

Templates for authorization letter, declaration, and labeling

Vietnamese translations for labels and IFUs

Guidance if you're switching AR or updating an existing listing

Contact Us：

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