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Found 10 records similar to Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Other items for an interim order submission

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
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

All Canadian-manufactured respirators must meet the minimum performance testing requirements.

Last Updated: Jul. 29, 2021
Date Published: Jan. 27, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, safety, performance specifications, filtering facepiece respirators, FFRs, Performance criteria
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

This interim order (IO) provides more tools for urgently addressing drug shortages related to COVID-19.

Last Updated: Apr. 30, 2021
Date Published: Oct. 16, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order, prevention and alleviation of shortages of drugs, drug shortages related to COVID-19
Federal

The purpose of this document is to provide guidance to manufacturers of serological assays intended for the detection of antibodies to SARS-CoV-2, the virus that causes COVID-19 disease. The guidance outlines recommendations regarding the minimum testing that should be performed for SARS-CoV-2 diagnostics.

Last Updated: May 11, 2020
Date Published: Apr. 24, 2020
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  COVID-19 pandemic, Antibody tests, serological assays.
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

The COVID-19 pandemic has created an urgent need for drugs, biocides, medical devices and foods for a special dietary purpose, and affected their supply in Canada. To help prevent or alleviate shortages of these products, the Minister of Health has signed an interim order (IO).

Last Updated: Apr. 30, 2021
Date Published: Mar. 1, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order, exceptional importation and sale, prevent shortages
Federal

IO No. 2 supports Canada’s continued focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.

Last Updated: May 28, 2021
Date Published: Apr. 28, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order No. 2, notice, clinical trials, medical devices, drugs, risks, health and safety
Federal

This list contains non-diagnostic devices of all classes - Classes I - IV - that are specifically authorized for use against COVID-19. These devices are authorized under the Interim order respecting the importation and sale of medical devices for use in relation to COVID-19. However, this list does not include all devices that can be used against COVID-19.

Last Updated: Apr. 15, 2020
Date Published: Apr. 12, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Applications for medical devices, Interim Order, COVID-19 related Medical devices.
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