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Found 10 records similar to Guidance document - Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices (2018)

Federal

This guidance document outlines the information considered necessary to support the safety and effectiveness of contact lens disinfectants, 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, contact lens, disinfectants, medical devices, medical device regulations
Federal

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.

Last Updated: Jan. 6, 2021
Date Published: Nov. 6, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, UV, ultraviolet radiation, UV decontamination devices, decontaminate medical devices, closed system devices, notice to manufacturers
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

The Canadian Medical Devices Sentinel Network (CMDSNet) is a pro-active surveillance program that encourages the reporting of medical device problem reports from all types of institutions.

Last Updated: Apr. 28, 2022
Date Published: Jun. 25, 2019
Organization: Health Canada
Formats: HTML
Keywords:  MedEffect Canada, report on adverse-reaction, report on side-effect, stay informed, Canadian-Medical-Devices Sentinel Network
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

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

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

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.
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

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
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