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The processing time for Class B medical device registration with the Vietnam Ministry of Health (MOH) is generally quite fast due to the simplified notification procedure established under Decree 98/2021/ND-CP.
⏱️ Processing Time Overview – Class B Devices
✅ 1. Normal Processing Time
Estimated Time: 3–10 working days
If the dossier is complete and accurate, the MOH will automatically issue a Device Listing Number.
⚠️ 2. Delays May Occur If:
Dossier is missing or incorrect
Documents are not properly translated or legalized
AR fails to properly complete online data entry
MOH system is under high volume (especially before regulatory deadlines)
📌 Regulatory Basis
Under Article 30 of Decree 98/2021, Class B devices follow a notification process, not a full registration with technical review.
The system will automatically issue a Listing Number once the application is complete.
🧭 Application Flow Summary
| Step | Description | Timeline |
|---|---|---|
| 1. Dossier Preparation | Collect and translate documents | ~1–2 weeks |
| 2. Online Submission | Via MOH portal dmec.moh.gov.vn | 1 day |
| 3. MOH Review | Automatic check for completeness | 3–10 working days |
| 4. Device Listed | Listing Number issued | Immediate after approval |
✅ Tip to Speed Things Up
Double-check document completeness and accuracy before submission
Ensure all documents are properly legalized and translated
Get a classification certificate in advance to avoid disputes
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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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