Health Canada Medical Device License (MDL) and Medical Device Establishment Licence (MDEL)
If you sell medical devices in Canada, you will need to secure up to two licenses. The first is called a Medical Device Establishment License (MDEL). The purpose of the medical device establishment license is to:
- Identify the companies importing or selling devices in Canada.
- Identify the manufacturer of the medical devices (if different).
- Determine the class of the device and other information.
This MDEL licence is secured only once but must be filed in the situations outlined below.
MEDICAL DEVICE ESTABLISHMENT LICENSE (MDEL)
Class 1 medical device manufacturers
You need to secure a Medical Device Establishment Licence (MDEL) if you sell direct and not through a distributor. If you sell through distributors in Canada, the distributor will likely have a Medical Device Establishment Licence so you do not need one.
Class 2, 3 or 4 medical device manufacturers
No MDEL is needed since you are being audited by a Registrar anyway.
MEDICAL DEVICE LICENSE (MDL)
The second type of license that many companies may need is called a Medical Device Licence (MDL). The MDL is a product approval and should not be confused with the MDEL which is a permit for the company/distributor itself. The Medical Device License (MDL) can be compared to the US FDA 510(k) process, except that the FDA only has Class 1, 2 and 3 classification, whereas Health Canada also has Class 4 devices. Compared to the FDA 510(k), the process of securing a MDL is usually faster for Class 2 devices, about the same for Class 3 devices and more complicated for Class 4 devices.
Class 1 medical device manufacturers
No Medical Device License is required.
Class 2, 3, 4 medical device manufacturers
Required. Filed by the manufacturer.
Emergo Group can help you complete the MDL and MDEL (if required) with Health Canada so that you may begin exporting to the Canadian market. We will 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 Medical Device License (MDL) application, if required.
In most cases, there is an annual fee for a MDEL in Canada. That fee depends on the your annual sales in Canada. There are no fees for Class 1 medical devices or devices used for investigational testing. Contact us today for more information.
