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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
5 days ago2 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


Singapore: Simplify CTGTP Licensing with SHARE (w.e.f. 10 February 2025)
The Health Sciences Authority (HSA) is excited to announce the launch of SHARE (Singapore Health Product Access and Regulatory E-System)...

ARQon
Feb 102 min read


Singapore: HSA Launches Pilot for Change Management Program (CMP) Targeting SaMD and AI-Driven Innovations (w.e.f 4 December 2024)
Singapore's Health Sciences Authority (HSA) is taking a significant step toward modernizing regulatory frameworks with its pilot for the...

ARQon
Dec 11, 20241 min read


Singapore: Cybersecurity Labelling Scheme Presents a New Standard for Medical Devices
On 16 October 2024, the Cybersecurity Labelling Scheme for Medical Devices (CLS [MD]) was officially launched, following a successful...

ARQon
Oct 17, 20241 min read


Singapore: SG-HSA eCTD Specification Package v1.0 (w.e.f 25 September 2024) and SHARE Portal Launching 7 October 2024 for Class 2 CTGTP Registration
The Health Sciences Authority (HSA) of Singapore released regulatory updates at the end of September 2024. The updates involve...

ARQon
Oct 1, 20242 min read


Singapore: Key Updates for Therapeutic Product Registration (w.e.f 1 Aug 2024)
The Therapeutic Products Branch (TPB) of the Health Science Authority (HSA) has announced the latest updates on regulatory procedures, as...

ARQon
Aug 6, 20242 min read


Singapore: "NextGen MD Initiative" for Next Generation Medical Device Registrations (w.e.f 1 July 2024)
“NextGen MD Initiative” was introduced by the Health Sciences Authority (HSA) on 13 June 2024 to facilitate the registration of...

ARQon
Jul 9, 20241 min read


Singapore: HSA stops provisional authorization applications for COVID-19 test & introduce PSAR
HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection, to...

ARQon
Jul 13, 20211 min read
Singapore: Guidances for Covid-19 Test, Mask, Thermometer, Sanitizers, Ventilators & 3DP Devices
COVID-19 Diagnostic Test kits To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional...

ARQon
Feb 3, 20213 min read
Singapore: Warning letters issued for fraudulent Covid-19 related claims
With increased surveillance on local e-commerce platforms and retail shops, over 1700 product listings have been removed for making false...

ARQon
Jan 27, 20211 min read
Special Access Routes for Covid-19 Related Products - ASEAN Countries
Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...

ARQon
Jan 27, 20212 min read
Singapore HSA finalized Registration Requirements for Next Generation Sequencing (NGS) IVDs
Health Sciences Authority (HSA) has finalized the specific requirements for registration of Next Generation Sequencing based In-vitro...

ARQon
Jan 30, 20201 min read
Singapore NEA: Listing Of Chemicals Under The Stockholm Convention
With effect from 12 Feb 2020, two new chemicals adopted for listing under Annex A of the Stockholm Convention (SC) will be controlled as...

ARQon
Jan 30, 20201 min read
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