On September 12, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition of Guidance Document MDA/GD/0068: Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification. This update aims to improve consistency, transparency, and efficiency of conformity assessments under Malaysia’s medical device regulatory framework.
On 19 September 2025, the Medical Device Authority (MDA) of Malaysia announced that Malaysia has officially become an Affiliate Member of the Medical Device Single Audit Program (MDSAP). This significant milestone aligns Malaysia with other participating regulatory authorities and strengthens its position in the global medical device regulatory framework. Scope
On September 5, 2025, the Ministry of Public Health of Thailand released a draft announcement regarding the Criteria, Methods, and Conditions for Recording and Reporting the Production, Import, or Sale of Medical Devices. This draft is issued under the authority of the Medical Device Act B.E. 2551, as amended, and
On September 2, 2025, the Ministry of Public Health released an announcement concerning the Advertising of Medical Devices in National or International Academic Exhibitions or Academic Conferences That Are Exempt from Needing Permission B.E. 2568. The regulation, issued under the authority of the Medical Device Act B.E. 2551, sets out
On September 4, 2025, the Health Sciences Authority (HSA) of Singapore issued Revision 2 of GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs). This revision aims to strike a balance between strengthening ethical safeguards for patients and easing operational demands on laboratories. Scope Guidance revision covering the use, regulation, and
On September 4, 2025, the Health Sciences Authority (HSA) of Singapore issued Revision 5 of GN-35: Guidance on Special Access Routes (SAR) for medical devices. This latest update introduces enhanced regulatory clarity and fully digitalised processes to facilitate access to unregistered medical devices in Singapore. Scope Summary results of the
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