The Ministry of Health has recently issued Circular 57/2025/TT-BYT to clarify the grouping of medical devices based on technical standards and quality criteria. This document serves as a vital framework for medical facilities to conduct bidder selection in accordance with the Law on Bidding and Decree 214/2025/ND-CP.
Under the new guidelines, medical devices are classified into 6 distinct groups. This classification is determined by a combination of the specific technical standards selected by the end-user and the product’s market authorization origin (whether it is within or outside the list of countries/organizations specified in the Circular’s Appendix). Notably, domestically manufactured products are eligible to participate in all bidding groups, provided they meet the corresponding technical requirements and hold legal circulation permits.
To be categorized into these groups, devices must ensure legal compliance in Vietnam and simultaneously satisfy the professional requirements of the using agency. These new regulations will officially take effect on February 15, 2026, aiming to establish a more transparent legal framework for public medical equipment procurement.