Singapore's Health Sciences Authority (HSA) is taking a significant step toward modernizing regulatory frameworks with its pilot for the...

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

The Health Sciences Authority (HSA) of Singapore released regulatory updates at the end of September 2024. The updates involve...

The Therapeutic Products Branch (TPB) of the Health Science Authority (HSA) has announced the latest updates on regulatory procedures, as...

“NextGen MD Initiative” was introduced by the Health Sciences Authority (HSA) on 13 June 2024 to facilitate the registration of...

HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection, to...

COVID-19 Diagnostic Test kits To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional...

With increased surveillance on local e-commerce platforms and retail shops, over 1700 product listings have been removed for making false...

Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...

Health Sciences Authority (HSA) has finalized the specific requirements for registration of Next Generation Sequencing based In-vitro...

With effect from 12 Feb 2020, two new chemicals adopted for listing under Annex A of the Stockholm Convention (SC) will be controlled as...

1) The Resource Sustainability Act (RSA), introduced by the Ministry of the Environment and Water Resources (MEWR), is an integral part...

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

Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...

Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...

Singapore Health Sciences Authority (HSA) final document presents the specific requirements applicable for NGS IVDs that are to be...

Following the consultation with industry since Aug 2016, the Singapore National Environment Agency (“NEA”) gazette additional controls...

Medical Device Pre-market Registration A submission guide that maps the various modules in our MEDICS system to the ASEAN CSDT dossier...

SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants BIA-ALCL is a cancer of the immune system and not a type of breast...

The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory...