Regulatory Open Forum

Need help with the folder structure requirements for submitting a product Class III with Health Canada as a private relabeler/repackager.  Also could not find the fees for this type of a submission? Any advice would be greatly appreciated.

Hello Anon

If you haven't already, check out these guidance documents.

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-amendment-private-label.html

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

Need help with the folder structure requirements for submitting a product Class III with Health Canada as a private relabeler/repackager.  Also could not find the fees for this type of a submission? Any advice would be greatly appreciated.