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.
“Use of the ToC formats will facilitate filing medical device applications for multiple jurisdictions and promote timely international access,” Health Canada said. “It will also support the transition to a Health Level-7 (HL7) electronic environment.”
HL7 is a messaging standard that supports submission of information for regulated products.
Health Canada in 2014 conducted a regional pilot allowing manufacturers to submit their regulatory dossiers using the ToC format. “The feedback from industry and participating regulators was positive and allowed the IMDRF to update and refine the ToC,” Health Canada noted.
Applicants who wish to submit in the ToC format before 1 April 2019, are encouraged to do so through the Health Canada regional ToC pilot and should contact the Medical Devices Bureau, Health Canada said.
Further guidance documents regarding filing in the ToC formats will be released as they become available, Health Canada noted.
Notice: Health Canada’s Intention to Adopt the Use of the Table of Contents Format for Class III and IV Premarket Medical Device Licence Applications