Singapore HSA Enhances Medical Device Change Notification Process
Singapore HSA has enhanced the Change Notification application process for Medical Device online platform (MEDICS) that will come into effect …
Singapore HSA Updates Guideline on Voluntary Notification System for Health Supplements and Traditional Medicines
HSA recently reviewed the newly implemented notification process, and HSA updated the Guideline on Voluntary Notification System for Health Supplements …
Singapore HSA Shares Statistic on HSA’s Mean Screening Time and Applicant’s Mean Screening Response Time For New Application and Major variation Applications
HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the …
Singapore Ministry of Health (MOH) Extends Special Access Routes (SAR) Review Timeline and Updates MOH Clinical Justifications Form for Class D SAR Application
Singapore MOH has updated the “MOH Clinical Justifications Form for Class D SAR Application” for the GN-26 and GN-27 SAR …
Singapore HSA Reviewed and Validated Medical Device Guidance Document Remains Valid
Singapore HSA reviewed several Medical Device Guidance Documents which were not updated since June 2018, and confirmed that the content …
Singapore HSA Announces Upcoming Regulatory Updates for Cosmetic Products
Singapore Health Sciences Authority (HSA) sent an email to industry stakeholders, announcing that there will be upcoming amendments to the …
Singapore HSA Updates GN-06: Guidance on Distribution Records for Medical Devices
HSA has included “ISO 13485:2016” in defining the projected useful life of a medical device. Product owners may refer to …
Singapore HSA Updates Medical Device Guidance GN-20: Guidance on Clinical Evaluation
HSA has specified “ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects” in GN-20: Guidance on Clinical Evaluation, …
Singapore HSA Publishes New Regulatory Guidelines for Laboratory Developed Tests (LDTs)
Laboratory Developed Tests (LDTs) are in vitro diagnostic tests (IVDs) that are: • developed and manufactured within a licensed clinical …
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