Canada – Health Canada to Adopt IMDRF Table of Contents Format

As part of a push toward regulatory convergence, as of 1 April 2019, medical device manufacturers will be expected to submit premarket applications for Class III and Class IV medical devices in Canada in either the International Medical Device Regulators Forum’s (IMDRF) table of contents (ToC) format or Health Canada format.

Health Canada announced Tuesday that the Summary Technical Documentation (STED) format will be discontinued as of 1 April 2019, and Health Canada will no longer accept applications in the STED format.

“The ToC is Health Canada’s preferred format as it is an internationally aligned structure accepted by other regulators,” Health Canada said.

The Regulated Product Submission (RPS) working group of IMDRF has developed the ToC formats for both in vitro diagnostic and non in vitro diagnostic devices…