Processing Time & Review Process for Class C Medical Device Registration with Vietnam MOH

The Class C medical device registration process with the Vietnam Ministry of Health (MOH) typically takes between 10 to 90 days, depending on the complexity of the application and MOH’s workload.

1. Estimated Processing Time

⏳ Standard Review Time: 10 – 90 days
📌 Factors affecting processing time:
✅ Completeness & accuracy of submitted documents.
✅ MOH workload and number of applications in queue.
✅ Additional information requests (if any) from MOH.

2. MOH Review Process Steps

Step 1: Application Submission (Day 1)

• The Local Authorized Representative (LAR) submits the application via the MOH DMEC online portal.

• Payment of registration fees.

Step 2: Preliminary Screening (Day 2 – 10)

MOH screens the application to check for missing or incorrect documents.
📌 If incomplete, MOH requests corrections → The applicant has 30 days to submit revisions.

Step 3: Technical Review & Evaluation (Day 11 – 90)

MOH experts review:
✅ Legal documents (CFS, ISO 13485, LOA, etc.).
✅ Technical files (risk classification, safety & performance tests, IFU, PMS plan, etc.).
✅ Compliance with ASEAN & ISO standards.

Step 4: MOH Decision & Approval (Day 30 – 90)

📌 Possible Outcomes:
1️⃣ Approval – A registration number is issued for indefinite validity.
2️⃣ Request for Additional Information (RAI) – MOH may ask for clarifications or additional documents (response required within 30 days).
3️⃣ Rejection – The application must be revised and resubmitted.

3. What Can Delay the Process?

🔸 Incomplete or incorrect documentation.
🔸 Missing Vietnamese translations of required documents.
🔸 Technical inconsistencies in the application.
🔸 Changes in MOH regulations requiring additional compliance steps.

Contact Us：

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