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Notice: Classification of Medicated Vapour Products December 8, 2015 Health Canada determines whether a product is to be regulated under the Food and Drugs Act (FDA) as a drug (i.e. pharmaceutical, biologic, or natural health product) or as a (medical) device. Detailed…

Notice: Classification of Non-medicated Eyewashes April 2, 2013 Our file number: 13-103438-115 Purpose Classification of a therapeutic product determines whether it is regulated as a drug [that is (i.e.) pharmaceutical, biologic, natural health product] or a medical device. The…

Notice: Classification of Dental Plaque-disclosing Products June 4, 2014 Our file number: 14-105696-421 Classification of a therapeutic product by Health Canada determines whether it is to be regulated under the Food and Drugs Act (F&DA) as a drug (that is [ i.e. ],…

Guidance document: Classification of products at the drug-medical device interface (PDF Version - 428 KB) Notice July 22, 2021 Our file number: 21-112631-972 Subject: Guidance document: Classification of products at the drug-medical device interface This guidance document was…

Pharmaceutical Drugs Directorate The Pharmaceutical Drugs Directorate (formerly the Therapeutic Products Directorate (TPD)) is Canada's regulator of prescription pharmaceutical drugs for human use. Before authorizing a drug for sale in Canada, we verify that it meets the safety,…

Drug Quality Surveillance Program Learn about the Drug Quality Surveillance Program, which monitors the quality of pharmaceutical products in Canada. On this page What we do About the laboratory program ROEB laboratories Contact us What we do Health Canada's mandate is to help…

Recalls The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. What is a recall? Legal Disclaimer…

Problem reporting Food and Drugs Act Liaison Office Health product complaint process Reporting complaints about health products Health Product Complaint Form (FRM-0317) Medical devices Handling complaints about medical devices (GUI-0065) Medical device complaint Recall Reporting…

Legislation and regulatory amendments In carrying out its compliance and enforcement functions, the Regulatory Operations and Enforcement Branch (ROEB) applies the Food and Drugs Act and its associated regulations. ROEB may engage in the development of new regulations to support…

Health products compliance: International agreements and collaboration activities This page provides a summary of Health Canada's Regulatory Operation and Enforcement Branch international collaboration on medicines between Canada and International partners. MRA - Mutual…