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
August 21, 2018
Our file number: 18-106132-568
The International Medical Device Regulators Forum (IMDRF) has identified the need to harmonize the documentation of evidence to support medical device market authorization requests. The Regulated Product Submission (RPS) working group of IMDRF has developed the Table of Contents (ToC) formats for both in vitro diagnostic (IVD) and non in vitro diagnostic (nIVD) devices, thereby promoting a globally harmonized structure for medical device applications. Use of the ToC formats will facilitate filing medical device applications for multiple jurisdictions and promote timely international access. 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. Each HL7 message includes the contents of a regulatory submission plus metadata that communicates the structure of the content and aids in electronic processing of submissions.
In October 2015, the IMDRF launched a pilot allowing manufacturers to submit their regulatory dossiers using the ToC format. Health Canada also launched a regional pilot in the fall of 2014. The feedback from industry and participating regulators was positive and allowed the IMDRF to update and refine the ToC.
Health Canada intends to adopt the ToC formats to encourage and support the global convergence of documentation requirements for medical devices. 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 formats. 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. Health Canada will also archive the guidance documents for the Health Canada format as of this date, although applicants may still use them for reference.
Applicants who wish to submit in the ToC format before April 1, 2019, are encouraged to do so through the Health Canada regional ToC pilot. Manufacturers interested in participating in the pilot should contact the Medical Devices Bureau.
Further guidance documents regarding filing in the ToC formats will be released as they become available.
Should you have any questions or comments relating to this notice, please contact the following:
Medical Devices Bureau
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower A
11 Holland Ave., 2nd floor
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-7285
E-mail: devicelicensing-homologationinstruments@hc-sc.gc.ca