Medical Device Regulations Database Canada

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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

Purpose. The purpose of this document is to provide a comprehensive list of Health Canada’s drug and medical device databases. These guidelines are designed to facilitate access to these databases and to inform stakeholders on what information is available. These databases include information on prescription and n… See more

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 …

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

Medical Devices Regulations. 1 - Interpretation; 2 - Application; 6 - Classification of Medical Devices; 8 - PART 1 - General. 8 - Application; 9 - …

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 Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device …

About medical devices - Canada.ca

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

Once a device receives the appropriate medical device licence, it can be distributed in Canada. Regulating and monitoring medical devices Like all health products, medical …

Incident reporting for medical devices: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

As is defined in section 1 of the Regulations, this term means a person who sells a medical device under their own name, or under a trade mark, design, trade name or other name or mark …

Medical device licensing - Canada.ca

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html

Medical device licensing - Canada.ca Canada.ca Health Drug and health products Licensing, authorizing and manufacturing drug and health products Medical …

Guidance on summary reports and issue …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html

Medical device licence holders must comply with the summary report provisions under sections 61.4 to 61.6 of the Regulations. Medical device licence holders include …

Canada - Regulatory Market Profile

https://www.rimsys.io/regulatory-market-profiles/canada

There are four major steps to bringing a medical device to market in Canada: Classify your device. Establish QMS procedures. Class II, III, IV must demonstrate compliance with …

Guidance on summary reports and issue-related …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/summary.html

Devices can be grouped into 1 of 4 types as defined in the Regulations: medical device family medical device group medical device group family or medical device system …

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