If you sell medical devices in Canada, you will probably need to secure a license. There are two licenses issued by Health Canada (Canada's FDA).
Health Canada Medical Device Establishment License (MDEL)
Class I medical device and in vitro diagnostic device manufacturers must secure a Medical Device Establishment License (MDEL) if selling directly into Canada and not through a distributor. However, if you sell through distributors in Canada, then your distributor must have an MDEL. Distributors and importers of medical devices and in vitro diagnostic devices, regardless of the device classifications, must secure a MDEL.
NOTE: Manufacturers of Class II, III and IV medical devices and in vitro diagnostic devices do not require an MDEL.
Health Canada Medical Device License (MDL)
The Canadian Medical Device License (MDL) is required for manufacturers of Class II, III, and IV medical devices in Canada. The MDL is a product approval and should not be confused with the MDEL, which is a permit for the company/distributor/importer itself. Canada's Medical Devices License (MDL) is comparable to the US FDA 510(k) process, except the process of securing a MDL is usually faster for Class II devices, about the same for Class III devices and more complicated for Class IV devices.
When applying for a Canadian Medical Device License, you will also need to prove that you have a certified ISO 13485:2003 quality system that ALSO meets the specific requirements of the Canadian Medical Device Regulations (CMDR). Emergo can help you implement ISO 13485:2003 or modify your existing system to meet the Canadian requirements, also known as the Canadian Medical Devices Conformity Assessment System (CMDCAS).
Emergo can complete the Health Canada MDL and MDEL (if required) so that you can start exporting to the Canadian market. We can help you:
- Determine the classification of your device in Canada, if unclear. See the Health Canada process chart for details.
- Determine the proper annual license fee payable to Health Canada.
- Complete and file the Canadian Medical Device License (MDL) or Medical Device Establishment Licence (MDEL) application.
- Develop, implement or modify your ISO 13485:2003 quality management system to meet the Canadian Medical Device Regulations (CMDR).
- Provide onsite employee training on ISO 13485:2003 and CMDR.
- Provide onsite auditing to confirm compliance with ISO 13485:2003 and CMDR.