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Found 10 records similar to Medical devices

Federal

Learn about medical device inspections.

Last Updated: Apr. 27, 2021
Date Published: Jan. 2, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Medical device, medical device inspection, inspection database, regulated inspections processes
Federal

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.

Last Updated: Sep. 17, 2020
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Safe 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

This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued.

Last Updated: Sep. 17, 2020
Date Published: Mar. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance on Medical Device Establishment Licensing, medical device industry, regulatory requirements of Medical Device.
Federal

List of medical device shortages related to COVID-19.

Last Updated: May 1, 2020
Date Published: Apr. 6, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, medical device, a medical device shortage, demand and urgent need for medical devices, a substitute device, component, accessory, or part.
Federal

List of specified medical devices related to COVID-19.

Last Updated: May 1, 2020
Date Published: Apr. 6, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, medical device, a medical device shortage, demand and urgent need for medical devices, a substitute device, component, accessory, or part.
Federal

Medical devices imported into Canada for sale, with or without a monetary contribution, must meet Health Canada requirements for commercial importation, as outlined in the Food and Drugs Act (FDA) and the Medical Devices Regulations (MDR).

Last Updated: Apr. 26, 2021
Date Published: Mar. 19, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guide, regulatory requirements, importing medical devices, commercial importation
Federal

A medical device shortage occurs when a manufacturer is unable to meet Canadian market demand for the device or for its components, accessories, parts or consumable materials. It does not include a situation in which a substitute device, component, accessory, or part is available.

Last Updated: May 1, 2020
Date Published: Apr. 6, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, medical device, medical device shortage, demand and urgent need for medical devices, a substitute device, component, accessory, or part.
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
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