Purpose of Obtaining Class C Medical Device Registration with Vietnam MOH

The purpose of Class C medical device registration with Vietnam’s Ministry of Health (MOH) is to ensure that medical devices meet regulatory, safety, and quality standards before they can be legally imported, sold, and used in Vietnam.

Key Objectives of Registration

1. Legal Market Entry & Compliance

✅ Mandatory for selling and distributing Class C medical devices in Vietnam.
✅ Ensures compliance with Decree No. 98/2021/ND-CP and Circular No. 39/2016/TT-BYT.
✅ Prevents regulatory violations, penalties, or product recalls.

2. Patient Safety & Public Health Protection

✅ Ensures devices are safe, effective, and meet international standards.
✅ Reduces risks of device malfunctions, adverse effects, or safety concerns.
✅ Requires compliance with post-market surveillance (PMS) and adverse event reporting.

3. Quality Assurance & Regulatory Oversight

✅ Confirms manufacturers follow ISO 13485:2016 (Quality Management System).
✅ Ensures compliance with ASEAN Medical Device Directive (AMDD) and international safety standards.
✅ Requires performance testing and clinical evaluation for high-risk devices.

4. Business Benefits & Market Expansion

✅ Grants official approval to import and distribute Class C devices in Vietnam.
✅ Builds credibility with hospitals, healthcare providers, and distributors.
✅ Opens access to public procurement opportunities and government contracts.

5. Post-Market Surveillance & Device Lifecycle Management

✅ Ensures continuous compliance through adverse event reporting and surveillance.
✅ Enables manufacturers to track device performance and safety over time.
✅ Provides a legal framework for product recalls or modifications if needed.

Conclusion

Registering a Class C medical device with Vietnam MOH is essential for legal sales, regulatory compliance, patient safety, and business expansion. It ensures that medical devices meet Vietnamese and international quality standards, protecting both users and manufacturers from potential risks.

Would you like guidance on the registration process, required documents, or compliance strategies? 😊

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