Central and South America - May 2020

  • 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

  • Ecuador: Revision of RTE INEN No 186 concerning electromedical equipment and systems has been published

  • Ecuador: Three dental equipment Technical Regulations repealed

  • Peru: Classification rules and Essential Principles of Safety and Performance published


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Argentina: Procedure for requesting an import authorisation for a medical product Argentina: Regulatory controls established for sunglasses Brazil: Class I medical devices and IVDs no longer require f

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