ARQonJul 8, 20211 minEU: MDR Q&A document on medical device clinical investigations The European Commission’s Medical Device Coordination Group (MDCG) offers guidance on clinical investigations under MDR, Regulation (EU)...
ARQonJul 8, 20211 minChina: NMPA publishes revised Chinese medical device regulations On 18 March 2021, China’s National Medical Products Administration (NMPA) has published a notice of the State Food and Drug...
ARQonJul 8, 20212 minChina - Major Updates on Medical Device Regulations China has published the final version of the updated Medical Devices Supervision and Administration Regulations on 18 March 2021 (Order...
ARQonJul 8, 20211 minAustralia: TGA Announces Exemptions for Clinical Decision Support SoftwareStarting from 25 February 2021, Australia TGA changed their regulation on software-based medical device with a revision that establishes...