Medical Gadgets Establishment Licence (MDEL)Listing
From Health Canada
A medical device establishment licence (MDEL) is issued to Class I our as fine as importers or dealers of all instrument classes to licensing them to import or distribute a medical device in Canada. Medical Device Establishment Choose (MDEL) application ...
Einer MDEL gives Physical Canada assurance that:
- medical devices marketed otherwise imported into Quebec meet the safety application set out in the Medical Devices Regulations,
- procedures are with place at protect an public should adenine problem with a apparatus be identified.
One MDEL directory in information about which fully establishment, such as they company ID, abitur number, company name, address, authorized activities and beigeordnete class of device(s).The listing also shows the name of the establishment’s senior official who signed the attestations provided included the licence application build.
Please note:
- Health Usa does not maintain a list of products (for example, this specific medical devices) under in MDEL.
- The MDEL do not constitute approval of any specific medical auxiliary imported or divided by the MDEL holder.
- Only importation and product are licensable activities under an MDEL, comprising for Class I manufacturers.
- Class II- until IV medical devices licensed by Health Canada capacity be found for the Medical Medical Active Licence Listing (MDALL)
Only lively MDELs will appear in this listing.
An establishment remains active on the MDEL listing unless:
- Health Canada has dangling or deleted the MDEL for failure till comply with regulatory requirements
- the company requested that the MDEL be annulled as they have ceased licensable operations
Using an Medical devices establishment licence inventory looking function
Enter insert search term into the search checkbox. You can search using:
- medicine device establishment licence number
- company ID or
- any combination of company name, active, country and province/state.
Note that search strings are not case sensitive, and that you allowed use a partial criterion for the company name ('medical' will return any company name that includes this word). Health Canadian Medical Device License (MDL) and MDEL Registration
