ARQonJan 27, 20212 minSpecial Access Routes for Covid-19 Related Products - ASEAN CountriesSingapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...
ARQonNov 11, 20202 minAsia, Africa & the Middle East - Nov 2020Australia: Updates to the definitions of medical device, accessory, instructions for use, user, and reusable surgical instrument...
ARQonNov 11, 20201 minCentral & South America - Nov 2020Brazil: Market access process is simplified for Class II devices Brazil: Changes to conformity assessment requirements for certain single...
ARQonNov 11, 20201 minNorth America - Nov 2020USA: FDA medical device user fees for fiscal year 2021 increase by about 7% USA: Proposed changes to regulations covering ‘intended use’...