Private Label Medical Devices Canada

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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. Private label medical devices are currently exempt from Division 2 - Fees for the Examination of Medical Devices Licence Applications contained in Part 3 - Medical Devices Fees of the Fees in Respect of Drugs and Medical Devices Regulations. …

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

In order for private label manufacturers to fulfil their medical device application requirements, Health Canada will accept a letter of authorization, written by the original …

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

Private Label Regulatory Correspondent Information (if applicable) Contact Name and Title: Company ID (if known): Company Name: Telephone: Fax: E-mail: …

Health Canada Guidance on Private Label …

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

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

PROMEDCANADA Inc. – MEDICAL …

https://www.promedcanada.com/

Promed Canada Inc. has been a manufacturer of private label medical devices since 2012. We are always looking to expand our product line and thus have recently added …

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

Private label applications: Optional 5.05 - Physician Labelling Folder name: 5.05-Physician Labelling Health Canada guidance Labelling directed at the physician other than the …

Guidance Document: Guidance for the Labelling of …

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

Each device including a system, medical device group, medical device family, or medical device group family must have a name. The device licence is issued for (a) the …

Medical devices - Canada.ca

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

Additional information on how medical devices are approved and authorized in Canada is available on the fact sheet "Safe Medical Devices in Canada" and the " …

Selling Medical Devices in Canada - Distributor? Private Label?

https://elsmar.com/elsmarqualityforum/threads/selling-medical-devices-in-canada-distributor-private-label.73617/

As a Canadian manufacturer of medical devices with MDSAP certification, I have considered doing something similar, i.e. taking a non-MDSAP certified product and …

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

Application for a Medical Device Licence Amendment for a Private Label Medical Device - Canada.ca Application for a Medical Device Licence Amendment for a …

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