ARQonDec 4, 20192 minAsia, Africa & Middle East - Nov/Dec 2019Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...
ARQonMar 28, 20191 minLicense Holder LRP, Submission for IVDMD & Regulation soon in Hong KongListing of LRP Hong Kong's Medical Device Control Office (MDCO) has plans to issue new Guidance Notes on the Listing of Local Responsible...
ARQonNov 5, 20181 minAsia, Africa & Middle East - Dec 2018AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...
ARQonSep 18, 20181 minHong Kong MDCO reveals Trial Scheme to speed up Medical Device RegistrationsMDCO has proposed a trial scheme for provisional approvals of Class II/III/IV Medical Devices. A list of criteria has to be fulfilled...