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Found 10 records similar to Regulatory requirements for importing medical devices

Federal

Medical devices included on this list are called "designated medical devices" and are eligible for the exceptional importation and sale provisions provided for in the Interim Order.

Last Updated: May 1, 2020
Date Published: Apr. 22, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, medical device, exceptional importation and sale of medical devices, Interim Order, regulatory requirements on imported and sold medical devices, designated medical devices
Federal

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.

Last Updated: Apr. 30, 2021
Date Published: Mar. 4, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, medical devices for COVID-19, importation and sale of medical devices, guidance document
Federal

There is an unprecedented demand and urgent need for access to medical devices during the COVID-19 pandemic. On March 30, 2020, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. The interim order (IO) allows certain medical devices that may not fully meet regulatory requirements to be imported and sold.

Last Updated: May 1, 2020
Date Published: Apr. 17, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, medical device, exceptional importation and sale of medical devices, Interim Order, regulatory requirements on imported and sold medical devices.
Federal

Health Canada's Medical Devices Regulations regulate traditional devices effectively. New technologies, such as software as a medical device, need more flexibility in our regulatory oversight.

Last Updated: Jun. 7, 2022
Date Published: Feb. 24, 2022
Organization: Health Canada
Formats: HTML
Keywords:  regulatory-innovation for health-products, agile-licensing for medical-devices, medical-devices regulations, new technologies, software as medical-device
Federal

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).

Last Updated: Oct. 2, 2020
Date Published: Sep. 28, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, reporting, medical device shortages, Interim Order, manufacturers and importers, list of Medical Devices, notification of Shortages
Federal

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).

Last Updated: Nov. 4, 2020
Date Published: Sep. 28, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, reporting, medical device shortages, Interim Order, manufacturers and importers, list of Medical Devices, notification of Shortages
Federal

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

Last Updated: Apr. 28, 2021
Date Published: Mar. 2, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, medical devices for COVID-19, importation and sale of medical devices, guidance document
Federal

This guidance document outlines the information considered necessary to support the safety and effectiveness of chemical products that are represented for use as high-level disinfectants and sterilants on reusable semi-critical and critical medical devices, which are regulated as medical devices under the Medical Devices Regulations.

Last Updated: Jul. 6, 2021
Date Published: Mar. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, safety and effectiveness requirements, high-level disinfectants and sterilants, reusable, semi-critical, critical, medical devices, safety and effectiveness of chemical products, reusable semi-critical
Federal

The Minister of Health, pursuant to subsection 30.1‍(1)Footnote(i) of the Food and Drugs Act Footnote(ii), makes the annexed Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

Last Updated: Apr. 7, 2020
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Interim Order, COVID-19 related Medical devices, Importation and Sale of Medical Devices, foreign regulatory authority, Drug product announcements.
Federal

The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. This guide provides information on how medical devices are approved and authorized in Canada.

Last Updated: Sep. 17, 2020
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Medical Devices, health or medical instruments, medical devices approved and authorized.
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