Timothy M. Squire

Fasken

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Changements à venir aux exigences du Règlement sur les instruments médicaux applicables après la mise en marché

Canada - March 25 2021 Des modifications récemment publiées au Règlement sur les instruments médicaux du Canada, dont l’entrée en vigueur est prévue en juin et en décembre…

Dara Jospé, Mark Vanderveken

Upcoming Changes to Post-Market Requirements Under the Medical Devices Regulations

Canada - March 25 2021 Recently published amendments to Canada’s Medical Devices Regulations, which will take effect in June and December of 2021, impose additional…

Dara Jospé, Mark Vanderveken

When is Software a Medical Device?

Canada - February 8 2019 Health Canada recently released a draft guidance document on software as a medical device (SaMD). This guidance is intended to help industry better…

Jean-Raphaël Champagne, Mathieu Gagné, Dara Jospé

Health Canada Announces Medical Device Safety Action Plan and Publishes Draft Guidance on Cybersecurity

Canada - January 16 2019 Health Canada recently released two significant forward-looking documents on the regulation of medical devices: Action Plan on Medical Devices:…

Mark Vanderveken

Draft Regulations Issued under Ontario's Health Sector Payment Transparency Act, 2017

Canada - March 8 2018 We previously reported on Ontario's Health Sector Payment Transparency Act, 2017 (the "Act"), which will require reporting of "transfers of value"…

Richard Y. Cheung, Christelle Gedeon, Lynne Golding, Ingrid E. VanderElst, Mark Vanderveken