Central & South America - Nov 2020

  • Brazil: Market access process is simplified for Class II devices

  • Brazil: Changes to conformity assessment requirements for certain single use devices

  • Brazil: Certified translations of documents waived

  • Brazil: Uploading Instructions for Use to ANVISA portal becomes mandatory

  • Brazil: New guide on cybersecurity is released by ANVISA

  • El Salvador: Technical Regulation published to set requirements for medical use face masks

  • Peru: Technical document on exceptional health authorisation of medical devices in the research stage

  • Peru: Validation guidelines for IVDs under clinical investigation in the context of the COVID-19 pandemic

Click here for the full article on Global Regulatory Press.

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