Canadian Approval Medical Devices

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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 information on how …

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

New class IV medical devices approved in 2020. Body fluid and tissue management devices. Body tissue manipulation and reparation devices. Cardiovascular devices. …

Drug and health product review and approval - Canada.ca

https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval.html

Mid-year update: Health products approved in 2021; Drug and medical device highlights 2020: Helping you maintain and improve your health; Mid-year update: Drugs and …

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

The Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate, Health Canada is the Canadian federal regulator responsible for licensing medical devices in …

Guidance documents – Medical devices - Canada.ca

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

Medical Devices Guidance Documents. Health Canada and FDA eSTAR pilot: Notice to industry [2023-01-10] The Health Canada eSTAR pilot program [2023-01-10] …

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

This does not mean the drug or medical device will immediately be available to patients, as many other factors can influence that timeline. In 2017, Health Canada approved 67 new …

Authorized COVID-19 medical devices: Overview

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

Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19 (enacted February 21, 2022) Included in this list are many devices, …

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

For more information about the import requirements of medical devices, contact Border Centres of Health Canada: Toll free (Canada and USA): 1-833-622-0414. From outside …

Health Canada Approval Process for Medical Devices: …

https://www.joharidigital.com/medical-device-registration-in-canada/

The Medical Device Manufacturers willing to place their medical devices in the Canadian market must have MDL as well as ISO 13485: 2016. Time needed for …

Hologic ablation device wins European, Canadian approval

https://www.massdevice.com/hologic-endometrial-ablation-european-canadian-approval/

The NovaSure V5 endometrial ablation device. [Image courtesy of Hologic] Hologic (Nasdaq:HOLX) announced today that Canadian and European officials …

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