Toward Global Harmonization - Health Canada to Adopt IMDRF Table of Contents Format for Class III and IV Applications
Posted: Monday October 22nd, 2018
Author: Karen Zhou
In another move toward global harmonization, by April 1, 2019, medical device manufacturers will be required to submit premarket applications for Class III and Class IV applications in Canada in either the International Medical Device Regulators Forum (IMDRF) table of contents (ToC) format or Health Canada format.
The Regulated Product Submission (RPS) group of IMDRF has developed the Table of Contents (ToC) formats for both in vitro diagnostics (IVD) and non in vitro (nIVD) devices to facilitate a globally harmonized structure for medical device applications. The format will also support the transition to Health Level-7 (HL7) electronic environment, a messaging standard that supports processing of electronic information.
Although Health Canada will accept either the ToC or Health Canada format, the regulatory agency prefers the ToC format because it is an internationally aligned structure accepted by other regulatory bodies. Guidance documents regarding the ToC format will become available later.
In addition, as of April 1, 2019, the Summary of Technical Documentation (STED) format will be discontinued along with its related guidance documents.
A 2014 pilot project allowing manufacturers to submit dossiers in the ToC format received positive feedback from both industry and participating regulators.
Manufacturers who wish to submit in the ToC format before April 1, 2019 are encouraged to do so through Health Canada’s regional ToC pilot and should contact the Medical Devices Bureau. The contact information is as follows:
Medical Devices Bureau
Therapeutic Products Directorate
Health Products and Food Branch
Holland Cross, Tower A
11 Holland Ave., 2nd floor
Address Locator: 3002A