Health Canada

How to import and sell designated biocides, propose an addition to the list of biocides and regulatory requirements for selling designated biocides.

There is an unprecedented demand and urgent need for access to biocides during the COVID-19 pandemic. On March 1, 2021, the Minister of Health signed Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. The interim order (IO)...

Health Canada issues Medical Device Establishment Licences (MDELs) to companies that import, distribute or manufacture Class I devices, and importers and distributors of Class II, III and IV devices. Establishments that do not respond to Health Canada's requests or provide the requested documents...

Medical devices that are eligible for importation and sale under the interim order (IO) are known as “designated” devices. They are included in the list of medical devices for exceptional importation and sale.

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, we continue to take a risk-based approach to inspections.

Health Canada has answered questions about access to controlled substances at the federal, provincial and territorial government levels. The answers may help health care providers better understand care options during the COVID-19 pandemic for patients who use drugs.

High-level description of when patients, practitioners and pharmacists are exempt from some sections of the Controlled Drugs and Substances Act during the COVID-19 (coronavirus) pandemic.

This toolkit provides information to support health care providers to understand their options in providing care for their patients who use drugs during the pandemic.

Targeted actions to reduce the risk of harm for people who use substances during the pandemic.

Between 2018 and 2020, Health Canada has issued a number of exemptions to the Controlled Drugs and Substances Act. Some of the exemptions have been issued to maintain Canadians' access to controlled substances during the COVID-19 pandemic.

Supportive online resources to help with pain management during COVID-19.

Health Canada is taking urgent measures to protect consumers from illegal, false or misleading advertising of products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

This notice outlines the safety and effectiveness requirements for closed system devices that decontaminate medical devices using ultraviolet (UV) radiation. The notice is for manufacturers using an interim order (IO) authorization or medical device licence application.

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment; the Minister of Health, pursuant to subsection 30.1‍(1)Footnote 1 of the Food and Drugs ActFootnote 2, makes the annexed Interim...

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment; the Minister of Health, pursuant to subsection 30.1‍(1)Footnote 1 of the Food and Drugs ActFootnote 2, makes the annexed Interim...

Health Canada scientific reviewers evaluate data to assess the potential benefits and risks of a drug or vaccine. They also review the information that will be provided to health care practitioners and consumers about the product. After the review, we may authorize the drug or vaccine for sale in...