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Found 10 records similar to COVID-19 guidance for reporting medical device shortages: Background

Federal

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).

Last Updated: Nov. 4, 2020
Date Published: Sep. 28, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, reporting, medical device shortages, Interim Order, manufacturers and importers, list of Medical Devices, notification of Shortages
Federal

This guidance document supports Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 2).

Last Updated: Apr. 30, 2021
Date Published: Mar. 17, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, guidance, reporting medical device shortages
Federal

Information on the updated list of medical devices for mandatory reporting of shortages in relation to COVID-19

Last Updated: Apr. 30, 2021
Date Published: Feb. 13, 2012
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, guidance, reporting medical device shortages, updated list of medical devices
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

During the COVID-19 pandemic, Health Canada is working closely with domestic and international partners to anticipate and meet Canadians' health product needs. This involves discussing, collaborating and leveraging resources on issues related to clinical trials and investigational testing, drug and medical device market authorizations, health product risk assessments, and potential drug and medical device shortages.

Last Updated: Jun. 7, 2022
Date Published: Jan. 12, 2022
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials, investigational testing, international engagement, domestic-and-international partners, collaborating and leveraging-resources, regulatory-response to COVID-19, market authorizations, health-product risk assessments, drug shortages
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 table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: Jun. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19, list of authorized clinical trials
Federal

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19
Federal

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19
Federal

In addition to existing medical device databases, there are lists of authorized COVID-19-related medical devices. These lists are a result of regulatory tools in place to expedite access to COVID-19 medical devices. The following information explains what resources to check to determine if a medical device has been licensed or authorized in Canada.

Last Updated: Jun. 30, 2021
Date Published: Apr. 8, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, authorized medical devices list, IO No.1, IO No.2, list of products no longer authorized
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