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Found 10 records similar to Notice – Important Regulatory Considerations for the Reprocessing of Single Use N95 Respirators during the COVID-19 Response

Federal

Information on the different types and uses of masks and respirators approved for use in Canada, and their importance during the COVID-19 pandemic to help slow the spread of coronavirus and protect health care providers.

Last Updated: Nov. 5, 2021
Date Published: Jun. 30, 2021
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  Medical, masks, respirators, Coronavirus, disease, health, product, industry, medical
Federal

Masks and respirators (personal respiratory protective devices) are essential during the COVID-19 outbreak. They help slow the spread of the disease in Canada and protect health care providers. Both masks and respirators need to be used in combination with appropriate eye protection (e.g., face shield, goggles) to achieve full protection of the eyes, nose and mouth.

Last Updated: May 7, 2020
Date Published: Apr. 17, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 outbreak, Masks and respirators, spread of a disease, protect health care providers, eye protection.
Federal

Reprocessing of devices intended for single use only is not a new concept. It has been done successfully with other devices used in Canada and similar technology can be applied to N95 respirators.

Last Updated: May 7, 2020
Date Published: Apr. 17, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 Response, Reprocessing of Single Use N95 Respirators, single use medical devices, airborne particles, decontamination and reuse.
Federal

This document provides guidance for Canadian manufacturers on the minimum technical requirements for facepiece filtering respirators (FFR). Health Canada has also published a guidance document to assist manufacturers in preparing applications submitted under the IO. This guidance document should be read in conjunction with this document.

Last Updated: Oct. 2, 2020
Date Published: Aug. 25, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, safety and performance, respirators, facepiece filtering respirators (FFR), guidance for Canadian manufacturers, minimum technical requirements
Federal

This document provides guidance for Canadian manufacturers on the minimum technical requirements for facepiece filtering respirators (FFR). Health Canada has also published a guidance document to assist manufacturers in preparing applications submitted under the IO. This guidance document should be read in conjunction with this document.

Last Updated: Nov. 4, 2020
Date Published: Aug. 25, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, safety and performance, respirators, facepiece filtering respirators (FFR), guidance for Canadian manufacturers, minimum technical requirements
Federal

Information about filtering facepiece respirators and their certification and testing process.

Last Updated: Jul. 29, 2021
Date Published: Apr. 2, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, safety, performance specifications, filtering facepiece respirators, FFRs, testing process
Federal

The Interim Order (IO) expedites the authorization of Class I to IV medical devices used for COVID-19: sets out the safety, effectiveness and quality requirements for filtering facepiece respirators (FFRs), and provides criteria for Canadian manufacturers developing respirators in Canada.

Last Updated: Jul. 29, 2021
Date Published: Jun. 11, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, Interim Order, expedites authorization, class I to IV medical devices, safety, effectiveness, quality, filtering facepiece respirators
Federal

Parents, caregivers and children across the country are facing new challenges as the COVID-19 pandemic affects our daily work and home routines. Schools, daycares and most workplaces have closed, and children and parents are suddenly at home full-time.

Last Updated: Nov. 4, 2020
Date Published: May 21, 2020
Organization: Public Health Agency of Canada
Formats: PDF HTML
Keywords:  COVID-19, Coronavirus, parenting, children
Federal

While diseases can make anyone sick, some Canadians are more at risk of getting an infection and developing severe complications due to their health, social and economic circumstances. Organizations, staff and volunteers play an important role in helping to prevent these populations from getting or spreading the COVID-19 virus. Start by sharing simple things they can do to help keep themselves and others healthy, guide them to help if they develop any signs and symptoms and learn ways help care for sick clients recovering from COVID-19.

Last Updated: Nov. 25, 2020
Date Published: May 1, 2020
Organization: Public Health Agency of Canada
Formats: PDF HTML
Keywords:  COVID-19 Pandemic, Vulnerable populations.
Federal

The Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 on March 18, 2020. A second Interim Order was introduced on March 1, 2021 and replaced the first one. The Interim Order (IO) expedites the authorization of Class I to IV medical devices used for COVID-19: sets out the safety, effectiveness and quality requirements for filtering facepiece respirators (FFRs) and provides criteria for Canadian manufacturers developing respirators in Canada

Last Updated: Jun. 30, 2021
Date Published: Aug. 25, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, safety and performance specifications, filtering facepiece respirators, FFRs, Interim Order, expedites the authorization of medical devices, Class I to IV medical devices used for COVID-19
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