How to Handle Class C Medical Device Registration with Vietnam MOH

Registering a Class C medical device in Vietnam requires accurate classification, proper document preparation, and compliance with MOH regulations. The process involves submission via the MOH DMEC online system, followed by a review and approval process.

Step-by-Step Guide to Handling Class C Registration

Step 1: Determine Device Classification

✅ Confirm that your device is Class C based on the ASEAN Medical Device Directive (AMDD).
✅ If uncertain, consult MOH guidelines or a regulatory expert.

Step 2: Appoint a Local Authorized Representative (LAR)

✅ Only a Vietnam-based company with a valid business license can submit the application.
✅ The LAR will handle submission, communication with MOH, and post-market compliance.

Step 3: Prepare Required Documents

📌 Legal & Administrative Documents

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

• ✅ ISO 13485:2016 Certificate (for quality management).

• ✅ Letter of Authorization (LOA) for the LAR.

📌 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 complexity and MOH workload.
📌 Possible Outcomes:

• Approval: A registration number is issued.

• Request for Additional Information: MOH may require clarification or extra documents.

• Rejection: If non-compliant, the application must be revised and resubmitted.

Step 6: Post-Approval Compliance

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

Contact Us：

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