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Malaysia: MDA, HSA, Forge Closer Ties with pilot Medical Device Regulatory Reliance Programme (1 Sept 2025 - 28 Feb 2026)
22 August 2025 marked a milestone moment for the medical device industry in Southeast Asia, as the Medical Device Authority (MDA) and the...

ARQon
Aug 252 min read


Singapore: HSA Tightens Therapeutic Product Registration (effective 30 July 2025)
As part of its ongoing efforts to streamline regulatory processes and ensure better clarity for applicants, the Health Sciences Authority...

ARQon
Aug 202 min read


Singapore: HSA Releases Updated SaMD and CDSS Guidelines (effective from 21 July 2025)
As the digital health landscape continues to evolve rapidly, the Health Sciences Authority (HSA) released the Revision 2 (R2) of its...

ARQon
Jul 232 min read


Singapore: HSA Updates GN-21, Now with Smarter Change Notifications for Medical Devices (effective from 14 July 2025)
The Health Sciences Authority (HSA) has announced the implementation of revised GN-21, which is set to take effect on 14 July 2025 . This...

ARQon
Jul 93 min read


Singapore: Hello SHARE, Your Quick Guide to the Big Switch
The Health Sciences Authority (HSA) is ushering in a new era for the medical device industry with the launch of the Singapore Health...

ARQon
Jun 51 min read


Singapore: HSA Opens Consultation on AI-SaMD Regulatory Sandbox
The Health Sciences Authority (HSA) launched a public consultation on a pivotal proposal that could significantly reshape the landscape...

ARQon
Jun 42 min read


Singapore: HSA Adopts ICH E6 (R3) GCP Guidelines (w.e.f. 1 January 2026)
The landscape of clinical research is constantly evolving, and with it, the standards that ensure trial integrity and participant safety...

ARQon
May 282 min read


Singapore: HSA's SHARE System Launch (July 2025) and Introductory Briefing Session (9 May 2025)
The Health Sciences Authority (HSA) is set to roll out a significant update to its regulatory infrastructure with the Singapore Health...

ARQon
Apr 291 min read


Singapore: HSA Calls for Stakeholder Feedback on Best Practice Guide for Medical Device Cybersecurity
The increasing integration of technology in healthcare has revolutionized patient care and introduced new cybersecurity challenges. As...

ARQon
Mar 182 min read
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