Notice: Applications for Medical Device Investigational Testing Authorizations – Changes to the Timing of Research Ethics Board (REB) Approval
October 1, 2018
Our file number: 18-107994-49
Effective immediately, Health Canada will issue a “Letter of Authorization” for investigational testing of Class III and IV medical devices, if the application meets the requirements stated in Part 3 of the Medical Devices Regulations, although Research Ethics Board (REB) approval may not be available at the time the Investigational Testing Authorization (ITA) application review has been completed.
Manufacturers and importers of Class III and IV medical devices are reminded that the REB approval letter must be submitted to Health Canada as soon as it becomes available and prior to study initiationFootnote 1.
The new Form, titled “Application for Revised Investigational Testing Authorization” should be provided as soon as the above-noted information becomes available. Please submit the form to: devicelicensing-homologationinstruments@hc-sc.gc.ca.
Health Canada is exploring various regulatory options on ways to harmonize the framework for investigational testing of medical devices with that of drug clinical trials. As more information becomes available, it will be posted on the Health Canada website.