ARQonSep 20, 20211 minUS: COVID-19 Emergency Use Authorizations for Medical DevicesThe secretary of Health and Human Services (HHS) announced that conditions exist in justifying the provision of emergency use of the...
ARQonSep 20, 20211 minUS: UDI Labelling requirements guidance finalisedUS FDA has published the finalised Labelling requirements guidance which assists labelers and FDA-accredited issuing agencies in...
ARQonSep 20, 20212 minTaiwan: Updates on COVID-19 measures, Final Exemption List, Cybersecurity StandardsMedical devices exempted from QMS certification requirements Taiwan Food and Drug Administration (TFDA) released the final list of...
ARQonSep 20, 20211 minSouth Korea: MFDS Medical Device Regulatory Revisions for 2022The Ministry of Food and Drug Safety (MFDS) plans to make multiple amendments to the country's Medical Device Act during 2022 and expand...