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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)
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.
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.
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).
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.
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.
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.
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.
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.
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).
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).