We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.
Importing into Canada requires more than clearing customs. Food, natural health products, and medical devices each have their own regulatory framework, and each requires a licensed Canadian importer of record before products can legally enter the country. QIS, a QSS company, provides that coverage across all categories.
Canada's import regulations are product-category specific. A food importer answers to the CFIA under the SFCR. An NHP importer operates under Health Canada's Natural Health Products Regulations. An MDEL import agent is accountable under the Medical Devices Regulations. In each case, the importer is the entity that stands behind your product on Canadian soil, named in your regulatory documentation and legally accountable for its compliance.
The importer of record is not a customs formality. Without a licensed importer in place for your specific product category, your products cannot be commercially imported and your Canadian market entry stalls before it begins.
Choosing a neutral, third-party importer also protects your commercial strategy. If your distributor holds the importer role, their name appears on your product across every channel. A neutral importer like QIS keeps your distribution options open as your Canadian presence grows.
We act as your licensed Health Canada importer of record for natural health products. This covers site licence annexation to add QIS as your Canadian importer, 12-month import coverage, COA and manufacturer testing gap assessment, NHP label compliance review, and ongoing lot release through the product disposition retainer. Every lot imported into Canada goes through a review and disposition process before it can be released for sale. Your NPN must be in place before the import programme can begin.
We act as your licensed food import agent under the Safe Food for Canadians Regulations for a 12-month period. This includes a FIOR hazard analysis for each product, a review of your manufacturer's food safety plan, and ongoing lot shipment oversight. The programme covers a defined number of products and unique lot shipments annually. QIS currently focuses on lower-risk food categories. Fresh or frozen meats, fresh vegetables, and foods in glass packaging fall outside the current scope.
We act as your licensed MDEL import agent for medical devices entering Canada. The MDEL import agent is a Canadian-based entity legally responsible for the importation of medical devices under the Medical Devices Regulations. Responsibilities include communicating with Health Canada on your behalf, responding to regulatory inquiries, supporting mandatory inspections, and ensuring all devices meet compliance requirements before and after import. All devices imported into Canada must be compliant with the Medical Devices Regulations, and non-compliance carries significant commercial and regulatory consequences.
A Canadian importer of record is a licensed entity that takes on legal accountability for the compliance of products imported into Canada. For food, this means accountability to the CFIA under the SFCR. For NHPs, it means accountability to Health Canada under the Natural Health Products Regulations. For medical devices, it means accountability under the Medical Devices Regulations. Without one, commercial importation cannot proceed.
No. A customs broker handles the administrative process of clearing goods through Canadian customs. An importer of record under Health Canada or the CFIA holds a distinct regulatory designation and is accountable for the safety and compliance of the products themselves. You may need both, but they serve different functions.
Technically yes, but it creates complications. The importer’s name appears on your product label and in your regulatory documentation. If your distributor holds that role and the relationship changes, relabelling and re-registration may be required. A neutral third-party importer like QIS avoids this problem entirely.
The regulatory requirements differ by category, so the programme structure differs too. QIS can act as your importer across food, NHPs, and medical devices, but each category is set up and managed according to its own regulatory framework.
For food importation under the SFCR, a documented food safety plan from your manufacturer is a prerequisite. If one is not in place, the import programme cannot commence until it is addressed. QIS reviews your manufacturer’s documentation as part of the setup process.
Setup timelines vary by category. NHP site licence annexation is subject to Health Canada processing, which typically runs 5 to 9 months. Food and MDEL programmes have different setup timelines. QIS will advise on expected timelines based on your specific situation during the initial assessment.
Each category carries ongoing obligations including annual renewals, lot-by-lot oversight, regulatory monitoring, and documentation management. QIS handles these proactively as part of your ongoing programme so your import activity stays in good standing year-round.