Open Government Portal

Found 10 records similar to Notice: Technical requirements for anti-microbial claims for medical masks

Federal

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.

Last Updated: Aug. 28, 2020
Date Published: Jul. 24, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, Notice to industry, regulatory framework for medical devices, non-medical masks, face coverings.
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

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).

Last Updated: Sep. 9, 2021
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, Natural Health Products Reg ulations, NHPR, notice, classification of non-medicated eyewashes, non-medicated eyewashes, classification of a therapeutic product, regulated as a drug
Federal

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.

Last Updated: Sep. 24, 2021
Date Published: Sep. 1, 2021
Organization: Health Canada
Formats: HTML
Keywords:  drug regulations, medical devices regulation, amending certain regulations, drugs shortages, medical devices shortages
Federal

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.

Last Updated: Oct. 21, 2022
Date Published: Sep. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Medical Devices Regulations, regulatory changes, new regulations, post-market surveillance, risk management
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 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.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  authorized investigational testing, authorized clinical-trials, release of information, medical-device investigational-testing Applications
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

Reporting requirements of serious adverse drug reactions and medical device incidents for hospitals.

Last Updated: Oct. 21, 2022
Date Published: Nov. 15, 2021
Organization: Health Canada
Formats: HTML
Keywords:  mandatory reporting-requirements, reporting-requirements for hospitals, reporting-requirements of serious-adverse-drug-reactions, reporting-requirements of serious-medical-device-incidents
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
Date modified: