Canada Health Product Registration
LMG provides guidance on Health Canada product registration for medical devices, drugs, natural health products, food, and cosmetics — in addition to our primary FDA consulting services.
Health Canada Registration Consulting
Canada's health product regulations are administered by Health Canada. LMG provides guidance on Health Canada registration requirements alongside FDA compliance consulting for manufacturers entering both the US and Canadian markets.
Medical Devices: Health Canada regulates medical devices through the Medical Devices Directorate. Class II–IV devices require a Medical Device Licence (MDL), which is the product authorization. In addition, a Medical Device Establishment Licence (MDEL) is required for Class I manufacturers and for all importers and distributors of any device class — so most foreign manufacturers entering Canada must also work with an MDEL holder.
Drugs & Natural Health Products: Health Canada regulates prescription drugs, OTC drugs, and natural health products (NHPs) separately. Prescription and OTC drugs require a Drug Identification Number (DIN) and market authorization, while NHPs require a Product Licence with a Natural Product Number (NPN) from Health Canada.
Food: Canadian food products must comply with the Safe Food for Canadians Act (SFCA) and the Food and Drugs Act.
Cosmetics: Cosmetics sold in Canada require a Cosmetic Notification Form (CNF), submitted under the Cosmetic Regulations.
Contact LMG for guidance on dual-market US/Canada regulatory strategy.
- Medical Device Licence (MDL) — required for Class II–IV devices in Canada
- Medical Device Establishment License (MDEL) — for Class I manufacturers and all importers/distributors
- Natural Health Product License — for vitamins, herbs, homeopathics
- Safe Food for Canadians Act compliance for food products
- Cosmetic notification under the Cosmetic Regulations
Frequently Asked Questions
Does LMG provide Health Canada consulting?
LMG provides guidance on Health Canada registration requirements alongside FDA consulting.
What is a Medical Device License in Canada?
A Medical Device License (MDL) is required by Health Canada for Class II, III, and IV medical devices sold in Canada.
Is Health Canada separate from FDA?
Yes. Health Canada regulates health products in Canada independently of the US FDA.
Need Canada Health Consulting?
Contact LMG for guidance on Health Canada registration alongside FDA compliance.
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