How to Apply for Class C Medical Device Registration with Vietnam MOH

Class C medical devices require registration with the Vietnam Ministry of Health (MOH) through the DMEC online system. The process involves classification, document preparation, submission, and approval.

Step-by-Step Application Process

1. Confirm Device Classification

✅ Check if your device falls under Class C based on the ASEAN Medical Device Directive (AMDD).
✅ If unsure, consult MOH guidance or a regulatory expert.

2. Appoint a Local Authorized Representative (LAR)

✅ Only a Vietnam-based company can submit the application.
✅ The LAR is responsible for application submission, communication with MOH, and post-market compliance.

3. Prepare Required Documents

📌 Legal & Administrative Documents

• ✅ Certificate of Free Sale (CFS) / Market Approval (Legalized).

• ✅ ISO 13485:2016 Certificate (Quality Management System).

• ✅ Letter of Authorization (LOA) (Legalized).

📌 Technical Documentation

• ✅ Device Description & Intended Use.

• ✅ Risk Classification Justification.

• ✅ Instructions for Use (IFU) & Labeling (Vietnamese translation required).

• ✅ Performance & Safety Test Reports (ISO/IEC standards).

• ✅ Clinical Evaluation Report (CER) (if applicable).

• ✅ Declaration of Conformity.

• ✅ Post-Market Surveillance (PMS) Plan.

📌 Other Requirements

• All foreign documents must be notarized and legalized.

• Vietnamese translations are required for labeling, IFU, and risk classification justification.

4. Submit Application via MOH DMEC Online System

✅ Log in to the MOH DMEC portal (https://dmec.moh.gov.vn).
✅ Upload all required documents in PDF format (max 10MB per file).
✅ Pay the application fee.

5. MOH Review & Approval Process

⏳ Processing Time: 10–90 days, depending on complexity and MOH workload.
📌 Review Steps:

• Preliminary Screening (10 days): MOH checks for missing/incorrect documents.

• Technical Evaluation (30–90 days): MOH reviews safety, efficacy, and compliance.

• Approval Issued: If compliant, the registration number is granted.

📌 Possible Outcomes:
✅ Approval – A registration number is issued (valid indefinitely).
❗ Request for Additional Information (RAI) – MOH asks for clarifications (response needed in 30 days).
❌ Rejection – If non-compliant, the application must be revised and resubmitted.

6. Post-Approval Compliance

✅ Follow Post-Market Surveillance (PMS) & Adverse Event Reporting regulations.
✅ Ensure compliance with labeling, IFU, and distribution requirements.
✅ Report any significant changes (e.g., manufacturer, design updates) to MOH.

Key Considerations for a Smooth Application

🔹 Ensure all documents are accurate, complete, and properly formatted before submission.
🔹 Work with an experienced Local Authorized Representative (LAR) to prevent delays.
🔹 Stay updated on Vietnam MOH regulatory changes to maintain compliance.

Contact Us：

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