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Health Canada published on August 21st, 2018 a notice confirming its “intention to Adopt the Use of the Table of Contents Format for Class III and IV Premarket Medical Device Licence Applications”, a gesture towards the efforts sustained by the IMDRF group to support medical device market authorization requests and encourage the global convergence of documentation requirements for medical devices and in vitro diagnostics.

Health Canada replace STED IMDRF ToC formatIt is the Regulated Product Submission (RPS) working group of IMDRF that developed the Table of Contents (ToC) formats for both in vitro diagnostic (IVD) and non in vitro diagnostic (nIVD) devices.

For Medical Device Manufacturers, this notice is clear: “As of April 1, 2019, manufacturers will be expected to submit premarket applications for Class III and Class IV medical devices in either the ToC or Health Canada formats”. It is important to note that the ToC is Health Canada's preferred format as it is an internationally aligned structure accepted by other regulators. Further to this, the notice explains that the Summary Technical Documentation (STED) format will be discontinued as of April 1, 2019, and that Health Canada will then no longer accept applications in the STED format.

More information can be found here.

Source : https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/toc-format-notice.html

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