Bringing a regulated product into Canada or the United States means meeting import requirements before a single unit crosses the border. QSS guides companies through every step, from documentation and licensing to importer of record obligations on both sides.
Canada’s import framework is product-specific and layered. Health Canada governs natural health products and medical devices. The CFIA governs food under the Safe Food for Canadians Regulations. Each pathway carries its own licensing, documentation, and ongoing importer obligations that apply before your product can be sold.
Getting this wrong creates real commercial exposure: shipments held at the border, product that cannot be released for sale, and launch timelines that compress the closer you get to market. Understanding your obligations in advance protects your market entry plan.
For most regulated categories, a licensed Canadian importer of record is required by law. That importer carries regulatory accountability for product quality, labelling, and where applicable, adverse event reporting. For companies also entering the U.S. market, FDA import requirements, including FSVP for food, add a parallel compliance track that must be managed alongside the Canadian pathway.
Each service below addresses a specific import pathway. Select the one that matches your product category and destination market.
MDEL Import (Medical Devices)
Companies importing Class II, III, or IV medical devices into Canada must hold a Medical Device Establishment Licence (MDEL). QSS supports initial MDEL applications, site amendments, and annual renewals for foreign device manufacturers and importers.
NHP Import (Natural Health Products)
Importing natural health products into Canada requires a Health Canada site-licensed importer of record. QSS acts as importer of record, managing QA obligations, product release, and Health Canada compliance so your product clears the border correctly.
Food Import Compliance
Food imported into Canada must meet CFIA requirements under the SFCR, including a licensed importer and a food safety plan from your manufacturer. QSS guides importers and suppliers through documentation, licensing, and readiness assessment.
Importer of Record Services
For companies without a Canadian presence, QSS provides third-party importer of record services. QSS holds the necessary site licences, manages QA documentation, and carries the regulatory responsibilities that Canadian law places on the importer.
FSVP U.S. Import Agent
Companies exporting food products into the United States must comply with the FDA’s Foreign Supplier Verification Program (FSVP). QSS acts as FSVP agent, managing supplier verification, hazard analysis, and recordkeeping requirements under 21 CFR Part 1 Subpart L.
Requirements vary by product category. Natural health products require a Health Canada site-licensed importer of record. Medical devices require an MDEL holder. Food importers must be licensed under the SFCR. If the product is regulated, there is almost certainly a licensing requirement attached to the import activity.
An NRI is a customs clearance program managed by Canada Revenue Agency and Canada Border Services. A Health Canada Importer of Record is a regulatory designation with quality assurance obligations, including product release, stability data, and in some cases adverse event reporting. These are separate requirements and one does not replace the other.
A distributor can, but this is not always advisable. The importer’s name must appear on NHP product labels, which creates dependency on that distributor relationship. A neutral third-party importer gives you flexibility to work with multiple distribution channels without reprinting labels when a relationship changes.
Your manufacturer must have a documented food safety plan, either a Preventive Control Plan (PCP) or a HACCP-based program. This is a prerequisite under the SFCR. The level of third-party certification your supplier holds can also affect the documentation required. QSS reviews supplier documentation as part of onboarding.
FSVP stands for the Foreign Supplier Verification Program, an FDA requirement under 21 CFR Part 1 Subpart L. It applies to importers bringing food into the United States from foreign suppliers and requires hazard analysis, supplier verification activities, and recordkeeping. QSS acts as FSVP agent for companies that need a qualified individual on file with the FDA.
Timeline varies by product category and the completeness of supplier documentation at the time of engagement. QSS recommends starting the process well in advance of your first planned shipment. Contact QSS to discuss your product category and timeline.
Yes. QSS advises on both Health Canada and FDA import requirements. FSVP agent services are available as a standalone engagement or as part of a broader North American market entry scope.
