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 …
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 …
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 …
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) …
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) …
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 …
Singapore adds controls to certain mercury-added medical devices under EPMA
Singapore adds certain medical devices to the control list of Mercury-Added Products under the Environmental Protection and Management Act (“EPMA”). …
Singapore HSA released registration requirements on Next Generation Sequencing IVDs
Singapore, Health Sciences Authority (HSA) released the final document on Next Generation Sequencing NGS IVDs. This document focuses on the …
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