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Found 10 records similar to Notice: Technical requirements for anti-microbial claims for medical masks
This notice explains under which circumstances non-medical masks or face coverings would be subject to the regulatory framework for medical devices during the COVID-19 pandemic.
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.
Classification of a therapeutic product determines whether it is regulated as a drug [that is (i.e.) pharmaceutical, biologic, natural health product] or a medical device. The purpose of this notice is to communicate Health Canada's current decision that non-medicated eyewashes should be regulated under the Natural Health Products Regulations (NHPR).
The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made on September 1st, 2021. They amend the Food and Drug Regulations and Medical Devices Regulations and are published in Canada Gazette, Part II.
Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by increasing post-market surveillance authorities.
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 purpose of this Notice is to communicate that, effective immediately, Health Canada will begin releasing certain information about authorized Investigational Testing (clinical trials) involving the use of medical devices in patients.
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.
Reporting requirements of serious adverse drug reactions and medical device incidents for hospitals.
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.