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Canada

Health Canada Medical Device Listing

Health Canada is the regulator of therapeutic products, including medical devices. Health Canada’s Medical Devices Active Licencing Listing (MDALL) contains a list of products that are already in the Canadian medical device market. It also contains the database for products that were previously licensed. This article discusses the various information available on MDALL. Read our article on overview of medical device registration in Canada to understand the various license requirements for diff...
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eSTAR Pilot program by Health Canada & US FDA

eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for 510(k)s and De Novos. The content of the form is automated with an automatic verification feature, and the structure is complementary to the internal review and also harmonized with the IMDRF and guided construction for each submission...
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