Approved Medical Devices Canada

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Additional …

Medical Devices Active Licence Listing (MDALL)

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

Health Canada is the federal regulator of therapeutic products, including medical devices. We do not provide medical advice on the use of the products identified in this listing. The …

Approved in 2020: Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020/approved-2020-medical-devices.html

4 New medical devices Chondro-Gide Bilayer Collagen Membrane. The Chondro-Gide Bilayer Collagen Membrane is a bilayer collagen membrane of... Myriad. Myriad is …

Authorized COVID-19 medical devices: Overview

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized.html

The list includes devices first permitted under the Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19 (March 30, 2020, …

Drug and Medical Device Databases - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/drug-and-medical-device-databases.html

Medical Devices Active Licence Listing (MDALL) - Your …

https://health-products.canada.ca/mdall-limh/index-eng.jsp

Medical Devices Active Licence Listing (MDALL) - Your reference tool for licensed medical devices in Canada From Health Canada Dear visitor, We have …

Drug and medical device approval overview - Canada.ca

https://www.canada.ca/en/services/health/drug-health-products/drug-medical-device-highlights-2017/approval-overview.html

When a new medical device is approved, it is issued a medical device licence. This does not mean the drug or medical device will immediately be available to patients, as many …

List of Recognized Standards for Medical Devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance.html

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents ISO 14971:2019-Ed.3.0 Medical devices - Application of risk management to medical …

Regulatory requirements for importing medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

Our Medical Devices Directorate (formerly the Medical Devices Bureau) helps to ensure the safety, effectiveness and quality of medical devices sold in Canada. The Medical …

Health Canada CMDR Medical Device Registration and Approval

https://www.emergobyul.com/services/canadian-cmdr-consulting-health-canada-medical-device-registration

Before you can market your medical device in Canada, you must comply with the Medical Device Single Audit Program (MDSAP), which includes compliance with the quality management system (QMS) requirements of the Canadian Medical Devices Regulations (CMDR) and obtaining the required level of approval from Health Canada.