February 2026

Malaysia: New Requirements for Procurement of Medical Devices by Healthcare Facility Institutions

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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 tenders and sets out mandatory […]

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Vietnam: New Radiation Safety Requirements for Medical Devices

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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 translation not available). Purpose of

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Rising Demand for IVD Tests Creates Opportunities in Southeast Asia

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The in vitro diagnostics (IVD) market in Southeast Asia is forecast to grow steadily, with projections showing a 7% CAGR from 2025 to 2032 and an expected value of 4.11 billion US dollars by 2032. IVD tests, including PCR, ELISA, and next-generation sequencing, are becoming central to healthcare delivery by supporting early disease detection, chronic

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