Preparations Before Applying for Class C Medical Device Registration with Vietnam MOH

Before submitting an application for Class C medical device registration with Vietnam’s Ministry of Health (MOH), thorough preparation is essential to avoid delays, ensure compliance, and streamline approval.

1. Confirm Device Classification

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

2. Appoint a Local Authorized Representative (LAR)

✅ A Vietnam-based company with a valid license must act as your Local Authorized Representative (LAR).
✅ The LAR is responsible for:

• Submitting the application.

• Communicating with MOH.

• Ensuring 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) – Appointing the LAR.

📌 Technical Documents

• ✅ Device Description & Intended Use

• ✅ Risk Classification Justification

• ✅ Instructions for Use (IFU) & Labeling (Vietnamese)

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

• ✅ 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. Test for Compliance with Vietnam MOH Standards

✅ Ensure the device meets relevant IEC, ISO, or ASTM standards.
✅ Conduct necessary safety, EMC, and biocompatibility testing.

5. Check MOH DMEC Portal Requirements

✅ Familiarize yourself with the MOH DMEC online registration system for digital submission.
✅ Ensure all documents are in the required format (PDF, max 10MB per file).

6. Plan for Processing Time & Fees

⏳ Processing Time: 10–90 days (may take longer in case of MOH requests).
💲 Registration Fee: Varies based on submission type; confirm with MOH.

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