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 …

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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 …

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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 …

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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, …

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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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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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Singapore HSA to Commence Phase 1 Implementation of Unique Device Identification (UDI) System

From 1st November 2022, all medical devices under the closed list of high-risk implantable published in HSA’s guidance document GN-36: …

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MDA Malaysia Releases Information on Harmonised Classification of Medical Devices in ASEAN

The Malaysian Medical Device Authority (MDA) has released the first edition of the guidance document on harmonised classification of regulations …

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Australia TGA Releases Guidance on Exemption for Certain Clinical Decision Support Software

The Therapeutic Goods Administration (TGA) Australia has released the first version of the guidance document on Exempt Clinical Decision Support …

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