Medical devices establishment licence listing
From Health Canada
A Medical Device Establishment Licence (MDEL) is a licence 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 provides Health Canada assurance that medical devices sold or imported into Canada meet the safety requirements set out in the Medical Devices Regulations, and that 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 including their company ID, licence number, company name, address, authorized activities and associated class of device(s).
Please note: Health Canada does not maintain a list of products (e.g. the specific medical devices) under an MDEL.
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).