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...
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ARQon
Oct 12 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...
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ARQon
Aug 62 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...
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ARQon
Jul 91 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...
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ARQon
Jul 13, 20211 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...
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ARQon
Feb 3, 20213 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...
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ARQon
Jan 27, 20211 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...
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ARQon
Jan 27, 20212 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...
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ARQon
Jan 30, 20201 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...
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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...
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ARQon
Jan 8, 20203 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...
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ARQon
Jan 7, 20201 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...
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ARQon
Jan 2, 20205 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...
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ARQon
Jan 2, 20203 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...
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ARQon
Dec 20, 20191 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...
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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...
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ARQon
Aug 29, 20191 min read
Singapore: Medical Device Regulatory Updates
Medical Device Pre-market Registration A submission guide that maps the various modules in our MEDICS system to the ASEAN CSDT dossier...
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ARQon
Jun 28, 20193 min read
Post Market Step up enforcements by Singapore HSA and Malaysia MDA
SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants BIA-ALCL is a cancer of the immune system and not a type of breast...
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ARQon
May 30, 20191 min read
IMDRF Clinical Documents for Public Consultation
The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory...
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ARQon
Mar 29, 20191 min read
HSA launches Singapore OSCAR online FSCA reporting and GN-21 update
Singapore Health Sciences Authority (HSA) shared the following updates on 28 March 2019: Update to the GN21 Change Notification (CN)...
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