Health Ministry Proposes Standardization of Medical Device Selection
Draft Circular Classifies Equipment Based on Technical and Quality Standards to Boost Transparency and Modernization
The Ministry of Health (MoH) is currently soliciting feedback on a vital Draft Circular. This document provides guidance on classifying medical devices based on technical standards and quality, aiming to establish a solid legal foundation for the procurement and utilization of equipment within the healthcare sector.
Strategic Objective and Legal Basis
The core purpose of the classification is to build a regulatory system that assists using units in identifying groups of medical devices with the most suitable technical standards and quality for their professional needs and financial capacity.
Crucially, this classification is expected to create a framework that enables investors and project owners to be more proactive in selecting advanced and modern medical devices, thereby enhancing the quality of healthcare services. The draft circular is a detailed implementation of the Government’s Decree No. 214/2025/NĐ-CP, which relates to the Law on Bidding regarding contractor selection.
Classification Principles and Circulation Requirements
The draft stipulates that medical devices, regardless of their classified group, must simultaneously meet both technical standards and quality requirements based on the practical needs of the using unit.
For domestically manufactured medical devices, they are eligible to participate in the corresponding groups if they meet the technical standards chosen by the using unit and are legally circulated in Vietnam. Recognized technical standards include National, International, Regional, Foreign, or Base (internal) Standards.
Structure of the 6 Classification Groups
The draft classifies medical devices into 6 groups based on a combination of Technical Standard requirements and Quality Origin (the country or organization permitting circulation):
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Regarding Technical Standards: Groups are differentiated based on whether the device has Conformity Certification under Vietnamese law, or additional foreign standard or base standard certifications.
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Regarding Quality: Groups are differentiated based on whether the device has circulation approval from at least 01 country/organization listed in the Appendix List (considered high-trust markets/organizations) or outside that list.
Specifically, the groups are structured in pairs (Groups 1 & 2, 3 & 4, 5 & 6) with the main difference lying in the quality origin. For example, Group 1 requires Conformity Certification and circulation approval from the Appendix List, while Group 2 requires Conformity Certification but with circulation approval from countries/organizations outside the Appendix List.
This detailed grouping aims to create flexibility while ensuring quality, allowing healthcare facilities to select equipment best suited to their professional capabilities and resources.
