If you are planning on selling medical devices or in vitro diagnostic devices (IVDs) in Canada, you will most likely need to register your product by securing a license. There are two types of licenses issued by Health Canada.
Health Canada Medical Device Establishment License (MDEL)
If you manufacture Class I medical devices or IVDs and plan on selling directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL).
If you choose to sell through distributors in Canada, your distributor requires have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.
Health Canada Medical Device License (MDL)
The Canadian Medical Device License (MDL) is required for companies selling Class II, III, or IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself.
Canada's Medical Devices License (MDL) is comparable to the US FDA 510(k) process. The process of securing an 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 management system that also meets the specific requirements of the Canadian Medical Devices Regulations (CMDR). You can read more about ISO 13485:2003 for Canada here.
How Emergo can help with Health Canada device approval
With offices in BC and Ontario, Emergo has experience helping more than one hundred medical device and IVD companies enter the Canadian market. Our services include:
- Confirming your device classification in Canada. See the Health Canada process chart for details.
- Completing and filing the Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf.
- Developing, implementing or modifying your ISO 13485:2003 quality management system to meet Canadian requirements.
- Providing onsite employee training on ISO 13485:2003 and Canadian Medical Devices Regulations (CMDR).
- Determining the proper annual license fee payable to Health Canada.
- Providing onsite auditing to confirm compliance with ISO 13485:2003 and CMDR.