Brazil: Electronic submission of application documentation to replace paper copies
Brazil: Proposal for ‘classifying’ medical devices as single use or reusable
Brazil: ABNT NBR IEC 60601-1-2:2010 is replaced by 2017 version
Peru: Addition of Hungary as a country of high sanitary surveillance
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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
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
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: Compu
