International Sponsor Program
U.S. Agent, official correspondent, IDE Sponsor of Record, and 510(k)/De Novo/PMA support for Canadian device manufacturers entering the U.S. market.
Health Canada regulates medical devices through its Medical Devices Bureau. Class II, III, and IV devices require a Medical Device Licence (MDL) before sale in Canada, while Class I manufacturers, importers, and distributors instead require a Medical Device Establishment Licence (MDEL). Canada's four-class system (Class I through Class IV) does not map one-to-one onto FDA's three-class system (Class I, Class II, Class III), so a Canadian manufacturer's device classification is re-established independently for the U.S. pathway rather than carried over from its Canadian class.
Canadian manufacturers of Class II, III, and IV devices typically hold a Medical Device Single Audit Program (MDSAP) certificate to support their MDL — Health Canada is one of the regulatory authorities participating in MDSAP, alongside FDA. Because an MDSAP audit already incorporates FDA's quality system expectations as one of its participating authorities, a Canadian manufacturer's existing quality system is usually close to QMSR-ready. The typical first step is a mapping and gap-closure exercise against the specific QMSR requirements not already covered by the MDSAP audit — not building a new quality system from scratch.
Canadian manufacturers bring a recurring set of pathway questions. A device already licensed in Canada but without a direct U.S. predicate raises the 510(k)-versus-De-Novo question the same way it would for any other market — a 510(k) where a suitable predicate exists, or a De Novo classification request where the device is novel but presents low-to-moderate risk. Clinical or real-world data collected to support a Canadian MDL can generally support a U.S. submission as well, evaluated against FDA's own evidentiary standards rather than accepted automatically. An existing MDL informs a U.S. submission — the device description, risk analysis, and underlying data are a useful starting point — but it does not substitute for FDA's own independent review.
A Canadian establishment required to register with FDA under 21 CFR Part 807 must designate a U.S. Agent and an official correspondent for premarket submissions, the same as a manufacturer from any other country. An existing relationship with a U.S. distributor does not satisfy this on its own — 21 CFR 807.40 prohibits a U.S. importer from simultaneously serving as the U.S. Agent, so the two roles stay separate regardless of how the Canadian company's U.S. commercial distribution is structured. Where a Canadian sponsor runs a U.S. clinical study under an Investigational Device Exemption, a U.S. Sponsor of Record under 21 CFR Part 812 takes on the full set of sponsor obligations — monitoring oversight, FDA reporting, and investigator agreements — on the Canadian company's behalf.
Most of Canada's population and device-industry base sits in time zones that overlap substantially with U.S. Eastern and Central time, which keeps scheduled calls and FDA-facing deadlines on a comfortable shared working day. All working documents are in English, program milestones and FDA correspondence are tracked through a secure client portal rather than email attachments, and the NDA, MSA, and statement of work are executed by electronic signature. To be direct about it: ADB is a U.S. firm serving Canadian sponsors from the United States — there is no Canada-based presence or representative, and we don't represent otherwise.
Device programs ADB sees from Canadian manufacturers commonly fall into digital health and AI/ML-enabled software as a medical device, cardiovascular and cardiac rhythm devices, orthopedic and surgical instruments, and diagnostics-adjacent devices. ADB's practice-director staffing model applies the same way regardless of device category — see Practice Groups for the full list of areas ADB supports.
Common Questions
An MDSAP certificate is a strong starting point since the audit already covers FDA's quality system expectations as one of the program's participating authorities, but MDSAP and QMSR aren't identical — a gap assessment against the specific QMSR requirements not already covered by the MDSAP audit is still the right first step.
A Medical Device Licence informs a U.S. submission — the device description, risk analysis, and clinical data behind it can support a 510(k) or De Novo file — but it does not substitute for FDA's own independent review, and Canada's four-class system does not map one-to-one onto FDA's three device classes, so classification is re-established for the U.S. pathway.
Yes — 21 CFR 807.40 prohibits a U.S. importer from simultaneously serving as the U.S. Agent, so an existing U.S. distributor relationship does not satisfy the requirement on its own. A Canadian establishment still needs a separately designated U.S. Agent before FDA establishment registration can complete.
A Canadian company can run a U.S. IDE study, but FDA requires a U.S.-based sponsor contact for it — which is what a U.S. Sponsor of Record under 21 CFR Part 812 provides. The U.S. Sponsor of Record takes on the full set of sponsor obligations for the study on the Canadian company's behalf.
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