Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices
Ecuador: Proposed revision of PRTE INEN No 186 concerning electromedical equipment and systems
Mexico: Compulsory standard drafted on Good Manufacturing Practices
Peru: Format for notifications concerning suspected adverse incidents
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Brazil: Resolution RDC No 340 and Normative Instruction 61 cover changes to information both pre- and post-market Brazil: Changes to requirements for syringes and infusion/transfusion pump sets Ecuado
RDC 232/2018 - Unique Device Identification (UDI) UDI will be enforced on 15 June 2020 that require product label with traceability using the bar codes with information including device identifier, ex
Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes and infusion/transfusion pump sets Ecuador: Technical Regulati
