Health Canada Update on Investigational Testing Authorizations for Medical Devices



Health Canada Update on Investigational Testing Authorizations for Medical Devices


Posted: Monday October 29th, 2018

Author: Pinky Mazumder 

Investigational Testing Authorization (ITA) issued by Health Canada, allows for the testing of Class II, III, and IV medical devices with human subjects. For unlicensed devices, the submission of an ITA is required to establish new safety and effectiveness data, however, ITAs are also required for licenced medical devices when establishing safety and effectiveness for new indications.

The application for an ITA requires the submission of the risk-based classification of the medical device, information on the institution at which the investigation will be conducted, along with the qualifications of the principal investigator, the study protocol, and the investigational device labels. In addition, for medical devices classified as Class III or IV, the sponsor is required to submit written approval from the Research Ethics Board (REB) for the study protocol at the specified site. Although the timeline for Health Canada review of an ITA application has a target of 30 days, the timeline for the REB approval process can vary depending on the risk associated with the study. As a result, Health Canada has acknowledged that sponsors of Class III and IV medical device ITA applications, may not receive REB approval for their study before the completion of Health Canada’s ITA review.

As a result, on October 1st, 2018 Health Canada published a Notice announcing that a Letter of Authorization may be issued for ITAs of Class III and IV medical devices even if the REB approval is not available at the time of the completion of the review. Issuance of the Letter of Authorization will also require the ITA application to be compliant with Part 3 of the Medical Device Regulations. When the REB approval is granted, sponsors of Class III and IV ITAs are required to submit the approval letter to Health Canada before the study is initiated and patients are enrolled.  Sponsors are required to complete the Application for Revised Investigational Testing Authorization form and submit it via email to hc.devicelicensing-homologationinstruments.sc@canada.ca.

Please note that while Class I medical devices do not require the submission of an ITA application for testing, they are still subject to the recordkeeping requirements set out in Part 3 Section 81 of the Medical Device Regulations and an REB approval is required. Sponsors of Class II medical device ITAs are also required to obtain REB approval prior to the initiation of their study but are not required to submit evidence of the REB approval to Health Canada. For more information, please refer to Table 1 and references provided below.

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References:

Health Canada - Notice: Applications for Medical Device Investigational Testing Authorizations – Changes to the Timing of Research Ethics Board (REB) approval https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/changes-information-requirements.html

Health Canada – Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations – https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/consulation-draft-investigational-testing-authorizations-guidance.html

Health Canada – Applications for Medical Device Investigational Testing Authorizations -

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/guidance-document.pdf

UHN - Overview of the Review Process http://www.uhnresearch.ca/content/overview-review-process