In today's notice Health Canada announces the end of the application for device licenses following the STED program by April 1st 2019.
Manufacturers are already encouraged to submit applications for device licenses in the nIVD(MA)ToC format, as published by IMDRF in 2015 as a pilot.
The latest and final 2018 version of the IMDRF guidance on "harmonized" Marketing Authorization submission is available on the IMDRF website.
Health Canada clearly states the following:
- 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 format.
- The ToC is Health Canada's preferred format as it is an internationally aligned structure accepted by other regulators.
- The Summary Technical Documentation (STED) format will be discontinued as of April 1, 2019, and Health Canada will no longer accept applications in the STED format.
Other regulatory Authorities such as Brazil's ANVISA are also working on pilot programs using the nIVD(MA) ToC.