Singapore HSA Streamlines Stability Data Requirements for Therapeutic Product Registration

Singapore HSA has revised the Guidance on Therapeutic Product Registration in Singapore and Related Appendices. The changes will take effect …

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Singapore HSA Singapore Launches New Digital Health Webpage

HSA launched this webpage in December 2020 as a one-stop portal to encourage innovation in the area of digital health …

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Singapore HSA to implement Medical Device Unique Device Identification (UDI) system

The Medical Devices Branch had organized a webinar on the Medical Device (MD) Unique Device Identification (UDI) System in Singapore …

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Singapore HSA Published Document Relating to Change Applications Arising from the EU MDR/IVDR related changes to registered medical devices

With EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR), the related changes will impact …

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UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium

The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. To accommodate …

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Singapore publishes Summary Reports of Benefit-Risk Assessment for NCE/NBE online

Effective from June 2020 onward the Health Sciences Authority, Singapore will be publishing the Summary Reports of Benefit-Risk Assessments for …

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Singapore launches new E-FORM for Therapeutic Products(TP)

Health Sciences Authority (HSA) Singapore launches a new online form to enable submission of post-approval documents/data of therapeutic products (TP) …

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Singapore launches new e-form for post-approval Registration Conditions of Therapeutic Products

Health Sciences Authority (HSA) Singapore launches a new online form to enable submission of post-approval documents/data of therapeutic products (TP) …

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Field Safety Corrective Action (FSCA) launched by HSA Singapore

Effective from 6 April 2020, the Health Science Authority(HSA ) of Singapore has launched the new OSCAR system for Field …

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