Health Canada License Medical Device

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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 Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate, Health Canada is the Canadian federal regulator responsible for licensing medical devices in accordance with the Food and Drugs Act and Regulations and the Medical Devices …

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

Access forms and guidance documents to help you apply for a medical device licence. Also search for a licensed device using the listing database. ... Health …

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 device application and report forms - Canada.ca

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

Application forms listed below must accompany medical device applications filed by a manufacturer or sponsor. Health Canada and FDA eSTAR pilot: Notice to …

About medical devices - Canada.ca

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

In Canada, medical devices are grouped into 4 classes based on the expected level of risk to a person's health and safety. Class I medical devices (e.g., a thermometer) pose the …

Guidance documents – Medical devices - Canada.ca

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

Fees for Medical Devices. For fee-related guidance documents and forms, please visit Fees for Medical Devices. Notice: Guidance Document Updates to Reflect …

Medical devices active licences search - health …

https://health-products.canada.ca/mdall-limh/prepareSearch-preparerRecherche.do?type=active

Medical devices active licences search. From Health Canada. Archived Licence Search. You may search by one of the following search options only: company …

Guidance Document - Medical Device Licence Renewal …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/medical-device-licence-renewal-fees-right-sell-licensed-2019/document.html

If a medical device licence has been cancelled, the product is no longer permitted to be offered for sale in Canada. In order to bring the medical device back into …

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