中文|English
中文|English
Does Class B medical device registration with the Vietnam MOH require annual renewal?
Release time：2025-04-07 14:42:50 The author: source:
No, Class B medical device registration with the Vietnam MOH does not require annual renewal.

No, Class B medical device registration with the Vietnam MOH does not require annual renewal.

✅ Key Point: No Annual Renewal Required

Under Decree 98/2021/ND-CP, once a Class B medical device is registered through the notification process, the Ministry of Health issues a product listing number (số lưu hành) that is:

➤ Valid Indefinitely

  • There is no expiration date.

  • No annual or periodic renewal is needed.

🔄 When Must You Update the Registration?

While renewal is not required, you must notify the MOH and possibly re-submit documents if major changes occur, such as:

ChangeAction Required
Change of authorized representative (AR)Re-submit listing with new AR
Change in manufacturer or addressNotify and update
Change in product name, model, or technical specsNotify MOH
Change in labeling or instructions for useUpdate with MOH
Post-market incident or recallReport immediately

📝 Summary

ItemDetail
Annual Renewal❌ Not required
Validity of Listing Number✅ Indefinite
MOH Update Required?✅ Only when there are major changes
Governing LawDecree 98/2021/ND-CP

Let me know if you need a template for updating registration or reporting product changes to the MOH. I can help with that too.

louis-reed-pwcKF7L4-no-unsplash(4).jpg

Contact Us：

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


Last one: How long does it take to obtain registration for Class B medical devices with the Vietnam MOH?
The next one: What is the purpose of registering Class B medical devices with the Vietnam MOH?
return