The Ministry of Health of Vietnam has issued Circular No. 57/2025/TT-BYT, providing detailed guidance on the classification of medical devices based on technical and quality standards. This initiative aims to streamline procurement processes, ensure compliance with international standards, and improve the quality of healthcare services.
Key Highlights of Circular 57/2025/TT-BYT
Legal Framework
The Circular is based on:
- Decree No. 214/2025/ND-CP: Detailing the implementation of the Law on Bidding regarding contractor selection
- Decree No. 98/2021/ND-CP: Regulations on medical device management, amended by Decree No. 07/2023/ND-CP
Medical Device Classification
Medical devices are categorized into six groups based on technical and quality standards. This classification system enables healthcare facilities to select appropriate equipment aligned with their needs and financial capacity.
Technical and Quality Standards
Medical devices must comply with one or more of the following standards:
- National standards
- International standards
- Regional standards
- Foreign standards
- Organizational standards
Decentralized Management
The Circular introduces decentralization of administrative responsibilities related to medical device management. This includes granting greater autonomy to local authorities in approving technical standards and making procurement decisions.
Benefits of the New Classification System
- Enhanced Quality Control: Ensures that only high-quality medical devices are procured and used in healthcare facilities
- Streamlined Procurement Processes: Provides clear guidance for evaluating technical compliance
- Cost Efficiency: Enables healthcare providers to make informed decisions based on both quality and budget considerations
Impact on Stakeholders
For Healthcare Facilities
The new classification system provides a clear framework for evaluating and selecting medical devices. By complying with the established standards, healthcare providers can:
- Ensure the safety and effectiveness of equipment in patient care
- Minimize risks associated with substandard or non-compliant devices
- Optimize operational efficiency by selecting equipment that meets both clinical and financial requirements
Additionally, clear classification supports better planning for maintenance, training, and system integration, ultimately improving patient outcomes.
For Manufacturers and Suppliers
Manufacturers and suppliers must adapt to the evolving regulatory landscape to remain competitive in Vietnam’s healthcare market. Key considerations include:
- Standards Compliance: Meeting technical and quality standards is essential for market entry and participation in public procurement
- Documentation and Transparency: Providing clear and comprehensive documentation is critical in the bidding process
- Market Differentiation: Companies that exceed minimum requirements or offer innovative solutions may gain a competitive advantage
Furthermore, the updated guidelines encourage investment in quality assurance and product innovation, fostering a more competitive and reliable medical device market.
For Regulatory Authorities
The decentralization of administrative responsibilities represents a significant shift in medical device governance. Local authorities will take a more active role in:
- Approving technical standards for medical devices
- Overseeing procurement processes to ensure compliance with national and international guidelines
- Addressing bottlenecks and challenges in approval procedures more efficiently
This approach reduces administrative burdens on central authorities while empowering local agencies to respond to regional needs. However, it also requires capacity-building initiatives to ensure local officials are adequately equipped to handle expanded responsibilities.
For Policymakers
Policymakers can leverage the updated classification system to:
- Promote transparency and accountability in procurement processes
- Encourage public-private collaboration to improve access to high-quality medical devices
- Align Vietnam’s healthcare standards with global best practices, enhancing the country’s credibility as a reliable market for medical technologies
By addressing these areas, policymakers can create a stronger regulatory environment that supports innovation while safeguarding public health.
Conclusion
Vietnam’s updated medical device classification standards represent a significant step forward in enhancing healthcare quality and efficiency. By adhering to these guidelines, stakeholders can ensure compliance, improve service quality, and contribute to the overall development of the healthcare sector.
Source: Thu Vien Phap Luat
https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-57-2025-TT-BYT-huong-dan-phan-nhom-thiet-bi-y-te-theo-tieu-chuan-ky-thuat-chat-luong-687442.aspx
