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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...

The purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.

Under the Interim Order, manufacturers and importers must report medical device shortages related to COVID-19 to Health Canada. The devices to which the shortages apply are on the List of Medical Devices — Notification of Shortages (specified medical devices).

This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway.

Most PPE, including face shields, are Class I medical devices if they are manufactured, sold or represented for use for reducing the risk of or preventing the user from infection. This includes COVID-19. Face shields may be authorized for sale or import into Canada through the following 3...

This document provides guidance for Canadian manufacturers on the minimum technical requirements for facepiece filtering respirators (FFR). Health Canada has also published a guidance document to assist manufacturers in preparing applications submitted under the IO. This guidance document should...