What Does Class C Medical Device Registration with Vietnam MOH Mean?

Class C medical device registration with Vietnam’s Ministry of Health (MOH) refers to the process of obtaining official approval for moderate- to high-risk medical devices to be legally sold and distributed in Vietnam.

This registration ensures that the device meets Vietnamese regulatory standards for safety, quality, and effectiveness, following the ASEAN Medical Device Directive (AMDD) and Vietnam MOH Circular No. 39/2016/TT-BYT.

Key Aspects of Class C Medical Device Registration

1. Definition of Class C Medical Devices

Class C medical devices are moderate- to high-risk devices that require more rigorous regulatory oversight than Class A (low risk) and Class B (low-moderate risk) devices.

📌 Examples of Class C Medical Devices:

• Infusion pumps

• Ventilators

• Dialysis machines

• Ultrasound imaging systems

• Surgical lasers

• Blood glucose monitoring systems

2. Why Registration is Required

✅ Ensures the device is safe, effective, and meets quality standards.
✅ Grants legal authorization to sell, distribute, and use the device in Vietnam.
✅ Ensures compliance with Vietnam’s regulatory framework and international medical device standards.

3. Regulatory Framework

Class C medical device registration in Vietnam follows these key regulations:
📌 Circular No. 39/2016/TT-BYT – Governs classification, registration, and post-market surveillance.
📌 ASEAN Medical Device Directive (AMDD) – Aligns Vietnam’s regulations with ASEAN countries.
📌 Decree No. 98/2021/ND-CP – Establishes new requirements for medical device registration.

4. Registration Process Overview

1️⃣ Determine Device Classification – Confirm Class C status based on risk level.
2️⃣ Appoint a Local Authorized Representative (LAR) – Only a Vietnam-based company can apply.
3️⃣ Prepare Required Documents – Legal, technical, and administrative documentation.
4️⃣ Submit Application via MOH DMEC Portal – Online submission and fee payment.
5️⃣ MOH Review & Approval – Evaluation, potential requests for additional information, and final approval.
6️⃣ Post-Market Compliance – Adverse event reporting and surveillance.

⏳ Processing Time: 10–90 days.
📜 Approval Validity: Indefinite (no expiration).

5. Key Considerations

🔹 Ensure complete documentation to prevent delays.
🔹 Work with an experienced Local Authorized Representative (LAR) to manage compliance.
🔹 Monitor Vietnam MOH regulatory updates for continued market access.

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