ARQonJun 30, 20202 minBrazil: UDI enforced & ANVISA RDC 356/2020 & RDC 379/2020 for Covid-19RDC 232/2018 - Unique Device Identification (UDI) UDI will be enforced on 15 June 2020 that require product label with traceability using...
ARQonDec 4, 20191 minCentral & South America - Nov/Dec 2019Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes...
ARQonAug 30, 20191 minCentral & South America - Aug 2019Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices Ecuador: Proposed revision of PRTE INEN No...
ARQonAug 30, 20191 minDrugs - Aug 2019China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...