Process and Steps for Class C Medical Device Registration with Vietnam MOH

Registering a Class C medical device in Vietnam requires submission through the Ministry of Health (MOH) DMEC online system. The process involves classification, document preparation, submission, and approval.

Step-by-Step Registration Process

1. Determine Device Classification

✅ Confirm that your device falls under Class C based on ASEAN Medical Device Directive (AMDD) criteria.
✅ If uncertain, consult MOH’s guidelines or a regulatory expert.

2. Appoint a Local Authorized Representative (LAR)

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

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 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.
📌 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.

6. Obtain Registration Certificate & Market the Device

✅ Once approved, the device can be legally imported and sold in Vietnam.
✅ The registration number is valid indefinitely (unless modifications require re-registration).

Post-Approval Obligations

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

Contact Us：

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