Medical Devices Establishment Licence (MDEL)Listing
From Health Canada
A medical device establishment licence (MDEL) is issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.
An MDEL gives Health Canada assurance that:
- medical devices sold or imported into Canada meet the safety requirements set out in the Medical Devices Regulations,
- procedures are in place to protect the public should a problem with a device be identified.
The MDEL listing contains information about the licensed establishment, such as their company ID, licence number, company name, address, authorized activities and associated class of device(s).The listing also shows the name of the establishment’s senior official who signed the attestations provided in the licence application form.
Please note:
- Health Canada does not maintain a list of products (for example, the specific medical devices) under an MDEL.
- The MDEL does not constitute approval of any specific medical devices imported or distributed by the MDEL holder.
- Only importation and distribution are licensable activities under an MDEL, including for Class I manufacturers.
- Class II- to IV medical devices licensed by Health Canada can be found on the Medical Devices Active Licence Listing (MDALL)
Only active MDELs will appear in this listing.
An establishment remains active on the MDEL listing unless:
- Health Canada has suspended or cancelled the MDEL for failure to comply with regulatory requirements
- the company requested that the MDEL be cancelled as they have ceased licensable activities
Using the Medical devices establishment licence listing search function
Enter your search term into the search box. You can search using:
- medical device establishment licence number
- company ID or
- any combination of company name, activity, country and province/state.
Note that search strings are not case sensitive, and that you may use a partial criterion for the company name ('medical' will return any company name that includes this word).