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The registration period for Class B medical devices with the Vietnam Ministry of Health (MOH) is as follows:
🕒 Registration Validity Period
Under Decree 98/2021/ND-CP, the registration of Class B devices is done via a notification process, and the resulting product listing number (số lưu hành) is:
✅ Valid Indefinitely
There is no expiration date for the listing number issued for Class B medical devices — it remains valid as long as there are no major changes to:
The device's technical specifications
The intended use
The manufacturer
The authorized representative (AR)
The labeling or packaging
🔄 When Do You Need to Update or Re-Register?
Even though the listing number does not expire, the following cases require an update or re-notification:
| Scenario | Required Action |
|---|---|
| Change of AR (Authorized Representative) | Submit a new notification |
| Change in manufacturer name or address | Notify MOH |
| Change in model name/technical characteristics | Notify MOH |
| Change in labeling or instructions for use | Notify MOH |
📝 Summary
| Item | Detail |
|---|---|
| Registration Validity | Indefinite (no expiry) |
| Renewal Required? | ❌ Not needed unless significant changes occur |
| Update/Change Notification | ✅ Required for major changes |
| Governing Regulation | Decree 98/2021/ND-CP |
Would you like a flowchart of when an update is required? Or help drafting a change notification form in Vietnamese? Let me know how you'd like to move forward!
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Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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