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
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
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
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
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
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
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
The new version Rev. No. 004 , issued on 28 April 2021, clarified on regulatory requirements for clinical trials of controlled drugs or psychotropic substances.
Additional import and export controls under the Health Products (Therapeutic Products)
HSA introduced the Dossier Clarification Supplement in April 2018 for chemical NDA and GDA to facilitate applicants to leverage the approval from a reference agency for the regulatory filing to