Canadian Medical Device Licence

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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

Guidance documents to help with applying for a medical device licence. Medical device licensing forms. Apply for a medical device licence. Contributors. …

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 …

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 …

Licences - Canada.ca

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

Medical Devices Licence Listings. Medical Devices Active Licence Listing (MDALL) Purchase of Licensed Medical Devices for Use in Health Care. Date: 2001-01 …

Guidance on how to complete the …

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

Overview. Medical devices are classified into one of 4 classes. Class I represents the lowest risk and Class IV represents the highest risk. Class II, III and IV medical devices must be licenced …

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 …

Medical Devices Active Licence Listing (MDALL) - Your …

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

Selecting the Active Licence Search link takes you to the Medical Devices Active Licence Search window. This window is identical to the original MDALL search …

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

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

34 - Application for a Medical Device Licence Amendment. 35 - Additional Information and Samples. 36 - Issuance. 37 - Lot of In Vitro Diagnostic Devices. 38 - Refusal to Issue. 39 …

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