The ASEAN ACCSQ-PPWG has endorsed the following documents.
(i) the ASEAN Variation Guideline (AVG) Rev. 2; endorsed at the 31st PPWG Meeting, and
(ii) Q&A for the Stability Guideline; endorsed intersessionally in August 2020.
The
Regulatory News
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 listed under the Medical Device Administrative Control System (MDACS) are required
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 Medical Devices into the Medical Device Administrative Control System (MDACS).
GN-02: Guidance Notes for
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.
Under the MDACS, the Local Responsible Persons (LRPs) are required, among
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 intended for supply in Australia and TGA’s framework for managing
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 able to inform, drive or replace clinical decisions, or directly provide
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 of active medical devices for therapy with a diagnostic function with meeting their
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 regulate and guide the pharmacovigilance activities of drug marketing authorization
China NMPA Establishes Patent Linkage Registration Platform
On May 18, 2021, China’s Center for Drug Evaluation of National Medical Products Administration (NMPA) issued the “Notice on the public testing of the patent information registration platform related to the early