Singapore HSA Publishes Regulatory Guideline for 3D-Printed Medical Devices

On 15th July 2021, HSA has finalised the Regulatory Guideline for 3D-printed medical devices. A separate FAQ has been compiled …

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Hong Kong DOH Updates List of Recognised Standards for Medical Devices

In May 2021, Hong Kong Department of Health updated the RS-01: List of Recognised Standards for Medical Devices  Medical devices …

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Hong Kong DOH Updates Guidances for Listing of General Medical Devices and IVDs

In April 2021, Hong Kong Department of Health updated the guidances for listing of Class II/III/IV General Medical Devices and Class B, C and D In Vitro Diagnostic …

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Hong Kong DOH Revised Submission Timeframes for Medical Device Adverse Event Reports

In April 2021, Hong Kong Department of Health updated the GN-03, Guidance Notes for Adverse Event Reporting by Local Responsible Persons.  …

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Australia TGA Updates Regulatory Position for Data Collection Components Used by Software As a Medical Device

Rapid innovation in technology has driven significant changes to software function and adoption, giving rise to a larger number of devices …

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Australia TGA Issues 3 Guidances on Transitional Arrangements and Obligations on Reclassification of Medical Devices in April 2021 

Reclassification of Active Medical Devices for Therapy with a Diagnostic Function. Version 1.0, April 2021: https://www.tga.gov.au/resource/reclassification-active-medical-devices-therapy-diagnostic-function   This guidance aims to assist sponsors …

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Malaysia MDA Issues Guidelines for Application for Medical Device Advertisement Approval – Requirements  

This guideline specifies the requirements for advertisement of medical devices that require approval and no approval required.  The following materials …

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Australia TGA Updates Comparable Devices in the Clinical Evidence Guidelines For Medical Devices

TGA has issued version 2.0 of Clinical evidence guidelines: Medical devices in March 2021 to update the section on Comparable …

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Singapore HSA Introduced New Self-Help Tool for Grouping of Medical Devices

On 25th February 2021, the Medical Devices Branch (MDB) has introduced a new self-help tool to guide in grouping of medical devices for …

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