21 CFR Part 812 · Health Canada Medical Devices Regulations
A Canadian company cannot sponsor its own US IDE under 21 CFR 812.18(a); a US sponsor of record must hold that role regardless of sequencing. Canadian manufacturers typically choose among three patterns: Health Canada licensure first, US IDE first, or parallel filing. This page compares the three and how each affects timeline.
The Rule
A company outside the United States cannot itself sponsor an FDA IDE study; a US person must act as sponsor and carry every sponsor obligation in Part 812. Canada is no exception to this rule.
"In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation."
21 CFR 812.18(a). Read the full section on eCFR →"A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor."
FDA, FAQs About Investigational Device Exemption. Read the FDA FAQ →How Canadian Manufacturers Sequence It
The manufacturer secures its Medical Device Establishment Licence (MDEL) and, for Class II, III, or IV devices, a Medical Device Licence (MDL), then initiates the US IDE. Clinical or bench data generated for the Canadian licence can support the US IDE where it meets FDA's evidentiary standard for data from outside the United States under 21 CFR 812.28, but Canadian licensure itself does not substitute for FDA review.
The manufacturer runs an early feasibility study or a pivotal IDE study in the United States ahead of Health Canada licensure, then pursues the Canadian MDL once US data exists. This pattern fits manufacturers prioritizing the larger US market or an indication where FDA's pathway is the critical path.
The manufacturer holds a Health Canada Investigational Testing Authorization (ITA) under Part 3 of the Medical Devices Regulations alongside a concurrent US IDE. In this pattern a Canadian sponsor holds the ITA for the Canadian sites and a separate US sponsor of record holds the IDE for the US sites; the two designations do not substitute for each other.
What Is Different for a Canadian Company
Most of Canada's device industry sits in time zones overlapping US Eastern and Central time, which keeps scheduled monitoring calls and FDA-facing deadlines on a comfortable shared working day; this is a practical convenience, not a regulatory shortcut.
USMCA, called CUSMA in Canada, does not change 21 CFR 812.18(a) in any respect; the sponsor residency requirement is unaffected by the trade agreement. CUSMA customs entry for an investigational device shipped into the United States still requires the same 812.18 importer and sponsor arrangement as a device arriving from any other country.
Where Canadian clinical data exists, 21 CFR 812.28 allows FDA to accept data from a well designed, well conducted investigation performed outside the United States, subject to independent ethics committee review, documented informed consent, and FDA's own evaluation; Canadian data is not accepted automatically, and the data acceptance route is separate from who the sponsor must be in the United States.
Step by Step
| Step | Health Canada | FDA |
|---|---|---|
| Device classification | Four class system (I through IV) under the Medical Devices Regulations | Three class system (I, II, III) under 21 CFR 860; re-established independently, not mapped from the Canadian class |
| Quality system | MDSAP certificate typically supports the MDL for Class II, III, IV devices | QMSR gap closure against items the MDSAP audit does not already cover |
| First in human / clinical authorization | Investigational Testing Authorization (ITA) under Part 3, for Class II, III, IV devices | Investigational Device Exemption (IDE) under 21 CFR Part 812, with a US sponsor of record |
| Premarket submission | Medical Device Licence (MDL) application to the Medical Devices Bureau | 510(k), De Novo, or PMA, depending on classification and predicate availability |
| Market authorization | MDL issued; MDEL required to distribute | 510(k) clearance, De Novo grant, or PMA approval; establishment registration and device listing required to distribute |
| Post market | Mandatory problem reporting and annual licence review | Medical device reporting (21 CFR Part 803) and post-market surveillance obligations |
The Three Structures
A non US manufacturer has three structures available to satisfy 21 CFR 812.18(a):
See FDA support for Canadian device manufacturers → · US Sponsor of Record tiers → · Use the decision tool → · Download the obligations checklist →
Common Questions
Yes. Under 21 CFR 812.18(a) a Canadian manufacturer cannot sponsor its own US IDE study regardless of its Health Canada licensure status; a US person must hold the sponsor of record role for the duration of the study.
Often, yes. 21 CFR 812.28 lets FDA accept data from a well designed, well conducted clinical investigation performed outside the United States, including Canada, subject to ethics committee review, informed consent, and FDA's own evaluation of the data.
Both authorize human testing of an unapproved device in their own jurisdiction, but neither substitutes for the other. A Health Canada Investigational Testing Authorization covers testing in Canada under Part 3 of the Medical Devices Regulations; an FDA IDE covers testing in the United States under 21 CFR Part 812.
Reviewed October 18, 2026 by ADB's regulatory team.
Need a Named Sponsor in Place?
For a scoping review of your specific study, start with the Sponsor Readiness Assessment on the US Sponsor of Record page, or reach the practice group directly.