Health Canada

Once a device is placed on the list, establishments must notify Health Canada at least 5 calendar days before the day on which the device is imported.

Information about a medical device must be available and in a form that is accessible to users, to ensure it is used safely.

List of terms used in the guidance document.

This guidance document is intended to help importers, distributors, manufacturers and other establishments meet their regulatory requirements.

During the COVID-19 pandemic, Health Canada is working closely with domestic and international partners to anticipate and meet Canadians' health product needs.

As part of the government's broad response to the pandemic, Health Canada introduced innovative and agile regulatory measures. These measures expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards.

During the COVID-19 pandemic, we continue to take a risk-based approach to inspections.

Learn how we conduct inspections of human cell, tissue and organ (CTO) establishments.

Any drugs sold to Canadians must remain safe and effective after they are approved for prescription and sale. Learn about good pharmacovigilance practices (GVP) and how Canada conducts GVP inspections.

Canada aims to reduce the risks to participants who enroll in clinical trials. Learn about clinical trial inspections and how we conduct them.

Canada aims to protect the safety of Canadian blood donors and recipients. This is done by monitoring and inspecting establishments that handle blood. Learn how we conduct these inspections.

This policy provides general information to any person – an individual or an organization that is involved in the import, export or transhipment of consumer products and cosmetics for commercial purposes.

The information in this guidance document will help to ensure that the health products you bring into Canada for commercial use meet the regulatory requirements of the Food and Drugs Act and its associated Regulations at the time of import. The guidance also provides information about exporting...

The Safety of Sperm and Ova Regulations focus on reducing the potential health risks to individuals in Canada who use donor sperm or ova (eggs) for the purpose of assisted human reproduction (AHR) to build their families. Health Canada conducts inspections of establishments and health...

Learn about medical device inspections.

Health Canada is responsible for many acts and their associated regulations that have a direct impact on the health and safety of Canadians.

Before drugs can be sold to Canadians, they must meet high safety and quality standards. This is the case for drugs made in Canada or abroad. Learn about drug inspections, how the Government of Canada (GC) conducts them and our licensing practices.

This guide is for anyone working with drugs or natural health products. It will help facilitate understanding and compliance with sections of the Food and Drugs Act (the Act), the Food and Drug Regulations (FDR) and Natural Health Products Regulations (NHPR) that relate to recalls.

Learn how and why we regulate controlled substances and their precursors.

This guidance document provides information about how to ensure that the health products you bring into Canada for commercial use meet the regulatory requirements of the Food and Drugs Act (Act) and its associated Regulations at the time of import. The guidance also provides information about...