Health Canada’s Guidance on Applications for Medical Device Investigational Testing Authorizations

Health Canada’s Guidance on Applications for Medical Device Investigational Testing Authorizations

Posted: Monday February 5th, 2018

Author: Pinky Mazumder 

In late 2017, Health Canada released a draft guidance document to assist sponsors, manufacturers, and importers on the authorization process for investigational testing of medical devices. The draft guidance, titled “Applications for Medical Device Investigational Testing Authorizations”, is open for consultation and supersedes the previous guidance document from 1999 (“Preparation of an Application for Investigational Testing – Medical Devices”).

An Investigational Testing Authorization (“ITA”) is required to sell or import a Class II, III, or IV medical device that is to be used for investigational testing. Although Class I medical devices do not require an ITA, the draft guidance document provides some information on the responsibilities of manufacturers and importers of Class I devices subject to investigational testing. As well, the draft guidance provides information on requesting a Pre-ITA Application meeting with Health Canada and the information required for the meeting, including a synopsis of the study and information package.  

An application for an ITA is to be submitted in non-eCTD electronic format and in a zipped folder structure. In addition, per the Medical Devices Regulations, an application for an ITA is to be submitted only by the manufacturer or importer of the device to be tested, however regulatory correspondence can be assigned to a regulatory agent. Health Canada’s expectations are also set out in the Medical Device Regulations and align with ISO 14155 on Clinical Investigation of Medical Devices for Human Subjects. Furthermore, for medical devices classified as Class III or Class IV devices, Health Canada can only issue an ITA after evidence of approval form the Research Ethics Board. For clinical trials with the use of an unlicensed medical device in Canada, an ITA application must also be filed for the device, along with the Clinical Trial Application (CTA) for the clinical trial.

The detailed regulatory requirements can be found in the draft guidance in the link below. Thank you for reading Regulated Affairs, the CAPRA blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.