Health Canada Medical Device Classification Database

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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 licence and are monitored by the Health Products and Food Branch Inspectorate (Compliance and …

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 - 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 …

Guidance Document - Guidance on the …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html

The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. The safety and effectiveness evidence required to support a medical device …

Guidance for Industry- Keyword Index to Assist

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

To search for a medical device group within the Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices portable document format (PDF) file, go to …

Classification of health products at the drug-medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/classification-health-products-device-drug-interface.html

The Medical Devices Regulations specify different requirements for products that pose different risks, ranging from lowest (i.e., Class I) to highest risk (i.e., Class IV). The …

Medical Devices Establishment Licence Listing

https://health-products.canada.ca/mdel-leim/index-eng.jsp

A Medical Device Establishment Licence (MDEL) is a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to …

Medical Devices Active Licence Listing (MDALL) - Your …

https://health-products.canada.ca/mdall-limh/

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

Medical Device Incidents - Drug and Health Product Register

https://hpr-rps.hres.ca/mdi_landing.php

Search Medical Device Incidents. Search for term (s) Download Full Extract. Disclaimer. Date modified: 2021-07-14.

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