Question 1

How long does Health Canada take to review an ITA?

Accepted Answer

The published review target is a study-specific timeline (we confirm it per protocol). It is a target — not a statutory clock, not an automatic authorization. Health Canada can issue questions or deficiency notices, and the ethics review, site contracting, and site readiness clocks run in parallel on their own timelines.

Question 2

What does the 30-day ITA target not include?

Accepted Answer

Everything except Health Canada's own review: research ethics board review, site identification and contracting, investigational device import logistics, insurance, and site initiation. Real-world activation averages roughly 17 weeks once those parallel workstreams are in motion.

Question 3

Is the ITA the same as a CTA?

Accepted Answer

No. A Clinical Trial Application (CTA) is the drug/biologic instrument — 30-calendar-day default review, 7-day review for Phase I bioequivalence, zero fees. An Investigational Testing Authorization (ITA) is the medical device instrument — 30-day review target.

Health Canada ITA for Medical Devices