Health Canada (HC)

Health Canada is the agency within the Government of Canada that leads national health policy to promote and protect the health and safety of Canadians. It oversees the regulation of health-related products and services, including medical devices, pharmaceutical drugs, natural health products, biologics, and foods. Health Canada operates under the Food and Drugs Act, the Medical Devices Regulations, and other relevant statutes.

Health Canada manages the full life cycle of health products to ensure they meet rigorous requirements for safety, efficacy, and quality. Pre-market licensing is conducted by the Medical Devices Bureau within the Therapeutic Products Directorate. Class II, III, and IV devices require a Medical Device Licence (MDL), while Class I devices do not require a product licence. Once applicable devices are licensed in Canada, Health Canada continues to monitor their performance through its Marketed Health Products Directorate, which oversees post-market surveillance, adverse event reporting, and product recalls.

When was Health Canada established?

Health Canada was established in 1993 and operates as a federal department under the Government of Canada.

How is Health Canada different from the Public Health Agency of Canada (PHAC)?

Health Canada and the Public Health Agency of Canada (PHAC) are distinct but work together to preserve the public health of Canadians. Health Canada focuses primarily on regulation, policy, and standard-setting, such as approving drugs and medical devices and setting food safety standards. PHAC, established in 2004, focuses on public health promotion and disease prevention, including infectious disease surveillance, emergency preparedness, and chronic disease prevention. During health emergencies such as the COVID-19 pandemic, Health Canada authorized vaccines and treatments while PHAC coordinated the public health response.

Does Health Canada charge fees?

Health Canada charges fees to recover a portion of the costs associated with reviewing and processing regulatory submissions. For medical devices specifically, fees apply to Medical Device Licence (MDL) applications, Medical Device Establishment Licence (MDEL) applications and renewals, and Licence amendments. Fees vary by application and device class. Eligible small businesses may receive fee reductions. Health Canada updates its fee schedules annually, so applicants should use the current official medical device fee page.

Website: Health Canada
Address: Health Canada, Address Locator 1801B, Ottawa, Ontario, K1A 0K9
Phone: 1-866-225-0709
Email: hcinfo.infosc@canada.ca