Health Canada will adopt the Table of Contents format for Class III and IV premarket medical device applications from April 1, 2019.
The change follows the International Medical Device Regulators Forum recommendation for harmonized formatting for medical device market authorization requests. In October 2015, the IMDRF launched a pilot program for submission of regulatory dossiers under the ToC format, which drew positive feedback from industry stakeholders.
Manufacturers will be expected to submit premarket applications for such devices in either the ToC or Health Canada format, according to the agency. Health Canada will discontinue use of the Summary Technical Documentation (STED) format on the same date and will no longer accept applications in that format.
The ToC format will improve the filing process for applications for multiple jurisdictions and better support the transition to the Health Level-7 messaging standard that supports submission of information for regulated products, the agency said. — Zack Budryk