Health Canada Private Label Medical Device License

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Private Label Medical Devices - Canada.ca

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

A. The device must be identical to the device that is licensed by the original manufacturer. The addition of a branding identification would be considered to be within the definition of a private label medical device. However, any variations in colour or design must be …

Guidance Document - Private Label Medical Devices

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

Private label manufacturers must comply with the requirements of the Medical Devices Regulations.In order for private label manufacturers to fulfil their …

Application for a New Medical Device Licence for a …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/application-new-medical-device-licence-private-label-medical-device.html

2011 Health Canada form. I have included in this application a Declaration of Compliance with the Medical Devices Regulations signed by a senior official of the …

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 …

Private label applications - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum/private-label-non-in-vitro-devices-in-vitro-devices-applications.html

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 …

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 …

Application for a Medical Device Licence Amendment for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/application-medical-device-licence-amendment-private-label.html

Addition/change/deletion of identifier (s) of the private label medical device (complete Item 5 below) 2. Information on the Currently Licensed Private Label Medical …

Health Canada Guidance on Private Label …

https://www.regdesk.co/health-canada-guidance-on-private-label-medical-devices/

Jul 14, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to completing …

Health Canada Guidance for Private Label …

https://www.regdesk.co/health-canada-guidance-for-private-label-medical-devices/

Apr 16, 2020. The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance dedicated to the application …

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