.png)
.jpg)
Processing Time for Class C Medical Device Registration with Vietnam MOH
The registration timeline for Class C medical devices in Vietnam depends on the completeness of the application, MOH workload, and potential requests for additional information.
1. Estimated Processing Time
| Step | Timeframe |
|---|---|
| Document Preparation & Legalization | 4-8 weeks (varies by country) |
| Submission via MOH DMEC Portal | 1-2 days |
| MOH Review & Approval | 10-90 days (may take up to 1 year in case of delays) |
| Marketing Authorization (MA) Certificate Issuance | 1-2 weeks |
Key Factors Affecting Processing Time
⏳ Delays (up to 1 year) may occur due to:
Incomplete documentation (missing legalizations, translations, or test reports).
Additional information requests from MOH.
High volume of applications.
Regulatory updates or changes in MOH requirements.
2. Tips to Expedite the Process
✅ Ensure all documents are notarized and legalized before submission.
✅ Use a certified translator for Vietnamese translations.
✅ Appoint an experienced Local Authorized Representative (LAR) for smooth submission.
✅ Monitor the MOH DMEC portal regularly for updates and respond quickly to requests.
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
.png)
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.
.png)