Health Canada

Not all reported medical device shortages are posted online. We only post actual or anticipated shortages when: they meet the definition of a medical device shortage and the manufacturer reporting the shortage does not have acceptable substitute options available for sale in Canada.

It's mandatory for manufacturers and designated importers, who have been authorized to report on behalf of a manufacturer to report discontinuations to Health Canada that will lead to a shortage for devices on the List of Medical Devices - Notification of Shortages.

Manufacturers of Class I to IV devices and importers of Class I devices must report shortages to Health Canada for medical devices that belong to a category included on the List of Medical Devices - Notification of Shortages.

Manufacturers of Class I to IV medical devices and importers of Class I medical devices must report the end of a medical device shortage for devices that are on the List of Medical Devices - Notification of Shortages.

Health Canada helps protect Canadians by minimizing the diversion and problematic use of controlled substances such as such as oxycodone, morphine, fentanyl and benzodiazepines. Health Canada’s Pharmacy Inspection Program does this, in part, by performing compliance and monitoring activities of...

As part of its regulatory responsibilities, Health Canada monitors compliance, undertakes enforcement activities and works towards preventing non-compliance. This policy describes Health Canada’s national compliance and enforcement approach for health products regulated under the Act and its...

Health Canada's approach to compliance and enforcement, including roles and responsibilities, actions and tools, guiding principles and decision factors.

The Regulatory Operations and Enforcement Branch of Health Canada is responsible for compliance and enforcement activities related to the Assisted Human Reproduction Act (the AHR Act) and its Regulations.

The Regulatory Operations and Enforcement Branch (ROEB) is responsible for health product compliance monitoring activities such as industry inspection and product investigation. ROEB develops and implements enforcement strategies in these areas.

The purpose of this policy is to inform stakeholders of the legislative provisions related to records accessed and obtained by inspectors during compliance and enforcement (C&E) activities, as provided for in the Food and Drugs Act (the Act), as well as the Government of Canada's policies in...

The purpose of this policy is to inform stakeholders of subsection 23(7) of Food and Drugs Act (Act), which authorizes designated inspectors to be accompanied by any other individual the inspector believes is necessary to help them exercise their powers or perform their duties or functions under...

This document provides guidance related to the registration and notification requirements under the Safety of Sperm and Ova Regulations (Safety Regulations) which are made under the authority of the Assisted Human Reproduction Act (AHR Act).

The Access Heads of Agencies have issued a collective statement that aligns with the Consortium’s strategic objective to expand and maximize collaboration through the life cycle of a product and solidifies the Consortium’s commitment to demonstrate greater inspection reliance and accept GMP...

An annual licence review (ALR) ensures that MDEL holders are complying with the regulatory requirements.

What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023

Due to remote working conditions implemented at the outset of the COVID-19 pandemic, Health Canada was unable to process paper-based requests for an MCE. We have modernized and streamlined the MCE process to better adapt to the demand for doing business online.

The purpose of this bulletin is two-fold: advise Medical Device Establishment Licence (MDEL) holders of the notice of intent published on December 11, 2021 and request their feedback on the cost-benefit analysis survey.

This notice is to inform licence holders that the List of Medical Devices – Notification of Shortages was updated on February 10, 2022, to include additional medical devices that require mandatory reporting by manufacturers and importers.

This document is intended to help ensure consistency among Health Canada inspectors during medical device establishment inspections when classifying observations of deviations, deficiencies or failures according to risk, and assigning an overall compliance rating to an inspection.

These guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain how inspectors assess compliance with the Food and Drugs Act (the Act) and Medical Devices Regulations (the Regulations).