Malaysia MDA Issued Guideline on Notification of Custom-Made Medical Device
Malaysia MDA issued the first edition guideline on Notification of Custom-Made Medical Device (MDA/GD/0064) on 28 February 2023. This guidance …
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 …
Malaysia MDA Implement Guideline On How To Submit An Application For Registration Of A Refurbished Medical Device
Malaysia MDA implement first edition guideline on “How To Submit An Application For Registration Of A Refurbished Medical Device (MDA/GL/10), …
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 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 …
Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration With Approval by The NRA of Any ASEAN Member Country
Philippines FDA issues Circular No. 2022-008 on 27th September 2022, aims to provide guidelines on the abridged processing of applications …
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