2020.02.23 EUにおける医療機器規制(MDR/IVDR) Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a 'person responsible for regulatory compliance'(PRRC)
2022.07.08 FDA Department of Health and Human Services (HHS) criticizes the status of FDA’s overseas inspections