Health Canada is revising its guidance issued in 1999 on investigational testing authorizations for medical devices.
The guidance is intended to aid device manufacturers and importers in the submission process for ITA applications to conduct investigational testing of a Class II, III or IV device, and provide details on their responsibilities when testing Class I devices.
Health Canada intends to only issue an ITA after receiving evidence of approval from a research ethics board (REB) for Class III and Class IV devices, and the authorization will be valid until the device is licensed as long as the REB approval is current.
For Class I devices, obtaining ITAs is not a requirement for a manufacturer or importer to sell a device to an investigator for investigational testing, though these must also receive REB approvals, as well as meet institutional requirements.
The guidance covers the use of recognized standards, drug-device combination products, investigator-sponsored investigational testing, stages of product development, revisions to an investigational testing protocol, and problem reporting. It does not cover in vitro diagnostics.