Question 1

How long does Health Canada take to authorize a medical device trial?

Accepted Answer

For drugs, a Clinical Trial Application (CTA) has a 30-calendar-day default review; Phase I bioequivalence reviews run on a 7-day review. For medical devices, the Investigational Testing Authorization (ITA) carries a 30-day review target — a target, not an automatic clock. None of this includes ethics review, site contracting, or site readiness. In practice, sponsors plan around real-world activation that varies by study (we confirm it per protocol) once ethics, contracting, and site readiness are in motion.

Question 2

Does Health Canada charge a fee for a Clinical Trial Application?

Accepted Answer

No. CTA fees are zero. That is one of Canada's genuine cost advantages — but the application is free, not the trial: site, ethics, monitoring, and per-patient costs are what drive the budget.

Question 3

Can a US startup claim Canadian SR&ED tax credits for a trial run in Canada?

Accepted Answer

Generally not without a Canadian footprint. SR&ED credits generally require a Canadian taxpayer or entity. Compare that to Australia's 43.5% R&D tax incentive, which is the competing incentive many startups evaluate. The incentive math only works if you can actually claim it.

Question 4

Does bioaccess® run trials in Canada?

Accepted Answer

Yes, on demand. We activate the right investigators, sites and regulatory resources on demand, anywhere in the Americas, from Canada to Argentina. For a Canadian study, we bring in the investigators, sites and Health Canada regulatory support the protocol needs when the program starts. Every program also gets U.S. FDA strategy and Pre-Sub support from Miami, and, where a study fits, our affiliated Miami cardiovascular site for Phase 1 and early device studies; first-in-human execution runs across 19 Latin American and Caribbean countries.

Medical Device Clinical Trials in Canada