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 …
ASEAN Revises the ASEAN Variation Guidelines and Issued The Q&A on ASEAN Stability Guidelines
The ASEAN ACCSQ-PPWG has endorsed the following documents. (i) the ASEAN Variation Guideline (AVG) Rev. 2; endorsed at the 31st …
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 …
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 …
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. …
Australia TGA Publishes New Guidance on the Management of GMP Compliance Signals
The guidance dated version 1.0 May 2021, outlines the Good Manufacturing Practice (GMP) compliance requirements for manufacturing biologicals and medicines …
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 …
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 …
China Issues New Pharmacovigilance Quality Management Practice/Standards
On 7th May 2021, China’s National Medical Products Administration issued a new Pharmacovigilance Quality Management Practice/Standards (ie. China GvP) to …