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Entering the Canadian market brings many opportunities, but understanding Health Canada rules can feel overwhelming. We guide you through the requirements for NHPs, food, cosmetics, medical devices, OTC drugs, veterinary products, and more. Our role is to make compliance clear so you can move forward with confidence.
Health Canada regulations can be complex, especially when requirements vary across product categories and change over time. Many companies face delays because of unclear expectations, documentation issues, or incomplete applications. We help you understand what is required and guide you through each step so you can move forward with clarity.
We support every major category regulated by Health Canada. Sections below link to dedicated service pages for deeper details.
Whether you are entering the U.S. for the first time or expanding your product lines, our team at Quality Smart Solutions can help you navigate FDA compliance with confidence.
Since 2007, we have helped more than 3,500 companies enter and expand in Canada. From new brands to global manufacturers, businesses trust us to deliver clarity, accuracy, and ongoing support.
Yes. All natural health products must receive an NPN from Health Canada. This process reviews your formula, safety data, and claims. We prepare and submit complete NPN applications and manage information requests during the review.
Health Canada requires a detailed formula, medicinal and non‑medicinal ingredient specifications, safety evidence, product claims, and bilingual labelling. We organize and prepare every component to meet the Natural Health Products Regulations.
Yes. Most consumer‑facing food products must display information in both English and French. This includes the Nutrition Facts Table, ingredient list, allergen statements, and core label elements. We support complete compliance and translation.
Foods with added vitamins, minerals, amino acids, or supplemental ingredients may fall under the Supplemented Foods regulations. These products have specific labelling, caution statements, and composition requirements. We help determine the correct category and ensure your label meets the new rules.
Class II, III, and IV devices require a Medical Device Licence (MDL). Companies that import or distribute devices must also hold a Medical Device Establishment License (MDEL). We prepare documentation, review technical files, and manage submissions for all device classes.
Cosmetics do not require pre‑market approval, but they must be notified to Health Canada within 10 days of first sale. Labels must also comply with Canadian requirements, including INCI names and bilingual text. We can assist you with the Cosmetic Notification submission and full label reviews.
DINs apply to OTC drugs and require more extensive evidence, strict labelling rules, and quality requirements. NPNs apply to natural health products with different evidence pathways and claim structures. We help classify your product correctly and prepare the right submission.
Yes. Veterinary Health Products must be registered under the VHP program and receive a Notification Number (NN) before they can be sold. They must contain permitted ingredients, follow specific labelling rules, and meet good manufacturing practices. We support registration, packaging reviews, and Importer of Record services.
Yes. We support renewals, technical updates, formulation changes, inspections, audits, and post‑market monitoring across multiple Health Canada categories.
Stay updated with the latest Health Canada regulatory changes, industry guidance, and insights that can help you make informed decisions and keep your products compliant.