The Medical Device Authority (MDA) has issued Circular Letter No. 1/2026, introducing new requirements under Act 737 governing the procurement of medical devices by healthcare facility institutions in Malaysia. These requirements take effect from 28 January 2026. The Circular clarifies the regulatory obligations applicable to companies participating in medical device
The Minister of Science and Technology has issued Circular No. 59/2025/TT-BKHCN, regulating radiation safety and preparedness and response to radiation and nuclear incidents. The Circular introduces comprehensive requirements on radiation safety in healthcare, with specific obligations applicable to radiation-related medical devices. Read the full circular here in Vietnamese: [PDF] (English
On January 27, 2026, the Medical Device Authority (MDA) of Malaysia hosted the “Shaping What’s Next 2026” ceremony in Putrajaya. The Chief Executive presented a comprehensive review of 2025 achievements and outlined the strategic roadmap for 2026. 2025 Performance Review: Global Leadership in Efficiency MDA demonstrated world-class regulatory efficiency in
The Thai Ministry of Public Health has issued a new Notification titled Principles, Methods, and Conditions for Displaying Labels and Medical Device Package Inserts, B.E. 2568 (2025). This Notification replaces the previous 2020 regulation and introduces streamlined labeling rules, harmonized package insert requirements for home-use and professional-use devices, updated provisions
The Government of Vietnam has issued Decree No. 342/2025/NĐ-CP, providing detailed guidance on the implementation of the Law on Advertising. The Decree consists of 5 chapters and 32 articles, establishing comprehensive rules governing advertising activities across multiple platforms and product categories. Read the full decree here: See attached Vietnamese document
The Ministry of Health has issued Circular No. 59/2025/TT-BYT amending Circular No. 05/2022/TT-BYT, which provides guidance on the implementation of certain provisions of Government Decree No. 98/2021/NĐ-CP on the management of medical devices. The amendment specifically updates Article 8, which outlines the roadmap for safety and technical performance testing of
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