Canada Medical Device License (MDL) Approvals and Registration

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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 manufacturers, importers and distributors must secure a Medical Device Establishment License (MDEL) if selling directly into Canada and not through a distributor. If you sell through distributors in Canada, then your distributor must have a MDEL. Class II,III and IV manufacturers do not require an MDEL.

Health Canada Medical Device License (MDL)

The Canadian Medical Device License (MDL) is required for companies which manufacture, import or distribute 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 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 Group can help you implement ISO 13485:2003 or modify your existing system to meet the Canadian requirements.

Emergo Group 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.
Determine the proper annual license fee payable to Health Canada.
Complete and file the Canadian Medical Device License 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.