
Jun 21, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published detailed guidance dedicated to all the aspects related to the medical device establishment license (MDEL). Apart from the regulatory procedures to be followed by an...
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May 27, 2021
EU MDR/IVDR
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. Notified Bodies: Legal Status The new framework introduced by these...
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May 14, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, has published an official notice on the reclassification of certain medical devices. According to the document, the TGA intends to review the existing...
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Apr 13, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to Pre-Requests for Designation (Pre-RFD). The document describes the approach to be applied by...
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Apr 9, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document describing how to write a Request for Designation (RFD). The document is intended to...
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