Comprehensive Guide to Medical Device Classification Standards in Vietnam

The Vietnamese Ministry of Health has issued Circular 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 benchmarks, and enhance the quality of healthcare services.

Key Highlights of Circular 57/2025/TT-BYT

Legal Framework

The circular is based on:

Decree 214/2025/NĐ-CP: Outlines the implementation of the Law on Bidding for contractor selection.

Decree 98/2021/NĐ-CP: Governs the management of medical devices, amended by Decree 07/2023/NĐ-CP.

Classification of Medical Devices

Medical devices are categorized into six groups based on their technical and quality standards. This classification ensures that healthcare providers can select devices that meet their specific needs and financial capabilities.

Technical and Quality Standards

Devices must comply with one or more of the following standards:

National standards

International standards

Regional standards

Foreign standards

Organizational standards

Administrative Decentralization

The circular proposes decentralizing administrative tasks related to medical device management. This includes granting local authorities more autonomy in approving technical standards and procurement decisions.

Benefits of the New Classification System

Enhanced Quality Control: Ensures that only high-quality devices are procured and used in healthcare facilities.

Streamlined Procurement: Simplifies the bidding process by providing clear guidelines for evaluating technical compliance.

Cost Efficiency: Helps healthcare providers make informed decisions based on both quality and budget considerations.

Implications for Stakeholders

For Healthcare Providers

The updated classification system provides healthcare providers with a structured framework to evaluate and select medical devices. By aligning procurement decisions with the outlined standards, providers can:

Ensure the safety and efficacy of devices used in patient care.

Minimize risks associated with substandard or non-compliant equipment.

Optimize operational efficiency by selecting devices that meet both clinical and financial requirements.

Additionally, the clear categorization of devices allows healthcare facilities to better plan for maintenance, training, and integration into existing systems, ultimately improving patient outcomes.

For Manufacturers and Suppliers

Manufacturers and suppliers must adapt to the new regulatory landscape to remain competitive in Vietnam's healthcare market. Key considerations include:

Compliance with Standards: Ensuring that products meet the required technical and quality benchmarks is essential for market entry and participation in public procurement.

Documentation and Transparency: Providing clear and comprehensive documentation to demonstrate compliance will be critical during the bidding process.

Market Differentiation: Companies that exceed the minimum standards or offer innovative solutions may gain a competitive edge in securing contracts.

Furthermore, the new guidelines encourage manufacturers to invest in quality assurance and product innovation, fostering a more competitive and reliable market for medical devices.

For Regulatory Authorities

The decentralization of administrative tasks represents a significant shift in how medical devices are managed. Local authorities will now play a more active role in:

Approving technical standards for devices.

Overseeing procurement processes to ensure compliance with national and international guidelines.

Addressing challenges and bottlenecks in the approval process more efficiently.

This approach not only reduces the administrative burden on central agencies but also empowers local authorities to respond to the specific needs of their regions. However, it also necessitates capacity-building initiatives to ensure that local officials are equipped to handle their expanded responsibilities effectively.

For Policymakers

Policymakers can leverage the updated classification system to:

Promote transparency and accountability in the procurement process.

Encourage collaboration between public and private sectors to improve access to high-quality medical devices.

Align Vietnam's healthcare standards with global best practices, enhancing the country's reputation as a reliable market for medical technology.

By addressing these aspects, policymakers can create a more robust regulatory environment that supports innovation while safeguarding public health.

Conclusion

Vietnam's updated medical device classification standards represent a significant step toward improving healthcare quality and efficiency. By adhering to these guidelines, stakeholders can ensure compliance, enhance service delivery, and contribute to the overall advancement of the healthcare sector.