To apply for Class B medical device registration in Vietnam, you must submit your application online through the official portal of the Vietnam Ministry of Health (MOH).

🌐 Where to Apply

👉 [Vietnam MOH Medical Device Portal (Cổng thông tin thiết bị y tế)]

🔗 Website: https://dmec.moh.gov.vn

📝 What You Need to Do on the Portal

Create an account

Only a Vietnam-based Authorized Representative (AR) can register and submit applications.

Log in as AR

Submit your device classification, dossier, and required documents.

Upload the dossier

Documents must be in Vietnamese or translated as per MOH requirements.

Track status online

Class B devices follow the notification route—if the dossier is complete, the system automatically issues a Listing Number.

⚠️ Important Notes

Foreign manufacturers cannot apply directly—they must go through a licensed Vietnamese Authorized Representative (AR).

All correspondence, approvals, and notifications are handled through the online system only.

Would you like:

A step-by-step guide to creating a portal account?

Help identifying a reliable Authorized Representative in Vietnam?

A checklist of what to upload?

Contact Us：

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