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

Registering a Class C medical device with the Vietnam Ministry of Health (MOH) involves submitting an application through the DMEC online portal, ensuring compliance with MOH regulations, and providing the required technical and administrative documentation.

Step-by-Step Registration and Application Process

Step 1: Determine Device Classification

✅ Identify whether your device falls under Class C based on the ASEAN Medical Device Directive (AMDD) and Vietnam MOH regulations.
✅ If unsure, consult a regulatory expert or refer to MOH Circular No. 39/2016/TT-BYT.

Step 2: Appoint a Local Authorized Representative (LAR)

✅ Only a Vietnam-based company with a valid business license can submit the application.
✅ The LAR is responsible for:

• Submitting the application.

• Handling communication with MOH.

• Ensuring post-market compliance.

Step 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 & notarized).

📌 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.

Step 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.

Step 5: MOH Review & Approval Process

⏳ Processing Time: 10–90 days, depending on MOH’s workload and application accuracy.
📌 Review Steps:
1️⃣ Preliminary Screening (10 days): MOH checks for missing/incorrect documents.
2️⃣ Technical Evaluation (30–90 days): MOH reviews safety, efficacy, and compliance.
3️⃣ Approval Issued: If compliant, a registration number is granted.

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

Step 6: Post-Approval Compliance

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

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