Central and South America - Aug 2020

  • Brazil: Temporary rules introduced for manufacture and supply of respiratory support equipment

  • Brazil: Information Note published on lung ventilators

  • Brazil: Updated rules for priority medical devices in the context of the COVID-19 pandemic

  • Brazil: Entry of device data in document repository system to become mandatory under proposal

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

  • Ecuador: Consultation held on draft Technical Regulation concerning assistive products for walking

  • Ecuador: Repeal postponed for three dental equipment Technical Regulations

  • Peru: Regulation drafted on minor and major changes to information stored in the medical device health register

  • Peru: Legislative changes in response to COVID-19

Click here for the full article on Global Regulatory Press.

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North America - Aug 2020

Canada: Regulatory Enrolment Process (REP) pilot expanded to include private label applications and amendments Canada: Temporary rules for conduct of, and access to, clinical trials for COVID-19 relat

Europe - Aug 2020

EU: Notified Body designation renewal process to be eased temporarily EU: Guidelines on the adoption of Union-wide derogations for medical devices EU: Guidance documents from the MDCG EU: Continued us

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