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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
Notification by the National Environment Agency (NEA) of New Regulated E-waste Management System
1) The Resource Sustainability Act (RSA), introduced by the Ministry of the Environment and Water Resources (MEWR), is an integral part...

ARQon
Jan 8, 20203 min read
Singapore Launch of OSCAR System for FSCA Reporting
Singapore Launch of OSCAR System for FSCA Reporting As part of HSA’s on-going effort to improve efficiency in our processes, HSA is...

ARQon
Jan 7, 20201 min read


Software Regulation and FSCA update for Singapore, Clinical Requirements update for China, Personali
Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...

ARQon
Jan 2, 20205 min read
Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft
Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...

ARQon
Jan 2, 20203 min read
Singapore published Final Guidelines on Next Generation Sequencing NGS IVDs
Singapore Health Sciences Authority (HSA) final document presents the specific requirements applicable for NGS IVDs that are to be...

ARQon
Dec 20, 20191 min read
Singapore NEA Additional Control List of Mercury-Added Product
Following the consultation with industry since Aug 2016, the Singapore National Environment Agency (“NEA”) gazette additional controls...

ARQon
Dec 20, 20191 min read
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