.png)
.jpg)
How Long Does It Take to Obtain Class C Medical Device Registration with Vietnam MOH?
The processing time for Class C medical device registration with Vietnam’s Ministry of Health (MOH) depends on the complexity of the application and MOH’s review process.
1. Estimated Processing Time
📌 Standard Processing Time: 10 to 90 days
10–30 days for well-prepared applications.
Up to 90 days if additional information or corrections are required.
⏳ Delays may occur due to:
🔹 Incomplete or incorrect documentation.
🔹 High application volume at MOH.
🔹 Additional review for complex or high-risk devices.
2. Step-by-Step Review Process & Timeline
| Step | Estimated Time |
|---|---|
| Step 1: Device Classification Confirmation | 1–3 days |
| Step 2: Appoint a Local Authorized Representative (LAR) | 3–7 days |
| Step 3: Prepare Required Documents | 2–4 weeks (depends on availability of documents) |
| Step 4: Submit Application to MOH (via DMEC Portal) | 1 day |
| Step 5: MOH Review & Request for Additional Information (if needed) | 10–90 days |
| Step 6: Approval & Issuance of Registration Number | Immediate after approval |
3. Factors Affecting Processing Time
⏳ Faster Approval (10–30 Days) If:
✅ The application is complete and accurate.
✅ The product is already approved by major regulatory bodies (e.g., FDA, CE, TGA).
✅ The applicant has a qualified Local Authorized Representative (LAR).
⏳ Slower Approval (Up to 90+ Days) If:
⚠️ Additional documentation or clarification is requested.
⚠️ The device requires special technical review (e.g., software-driven, implantable devices).
⚠️ MOH has a high volume of applications.
Conclusion
📌 Typical approval time: 10–90 days.
📌 Preparation and document accuracy are key to avoiding delays.
📌 Post-market compliance is required after approval.
Would you like help with document preparation, submission, or compliance strategies to speed up the process? 😊
.jpg "laboratory-3827742_1280(6).jpg")
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)