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
On 28 August 2025, Futurise Sdn Bhd, a wholly-owned subsidiary of Cyberview Sdn Bhd under the Ministry of Finance, in collaboration with the Medical Device Authority (MDA), hosted RegTalk 2025: AI Medical Devices in Malaysia – Balancing Innovation and Safety at the Siemens Healthineers Experience Center, Kuala Lumpur. The session
On June 5, 2025, the Ministry of Health of Indonesia issued Government Regulation No. 28 of 2025 concerning the Implementation of Risk-Based Business Licensing for Medical Device Distribution Facilities. Scope Summary results of the Socialization of the Indonesian Ministry of Health. Key Points In Appendix II of Government Regulation No.
Notification Letter No. BJ.01.03/A.VI/6405/2025 regarding the transition of medical device product display to Electronic Catalogue (E-Catalogue) Version 6. This action follows Circular Letter No. 2 of 2025 from the Head of the Policy Institute for Procurement of Goods/Services (LKPP), which stipulates that E-Catalogue Version 5 for the health showcase will
On August 18, 2025, the Medical Device Authority of Malaysia (MDA) has updated the infographic (only editorial changes) related to REQUIREMENTS ON QUALITY MANAGEMENT SYSTEM (QMS) AND TRACEABILITY FORM applies to new medical device applications and re-registration medical device applications submitted from 1 January 2024. This infographic refers to the
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