Canada Medical Device License Application

As specified by the law Canada Food and Drug Act SOR / 98-282, anyone selling medical devices into the Canadian market is required to register

with Health Canada (HC) before they do so.

Health Canada (HC) classifies medical devices into four classifications:

Class I, Class II, Class III and Class IV. The manufacturers of Class II, Class III and Class IV products are required to meet the requirements of CAN/

CSA ISO 13485 and to obtain a Medical Device License (MDL) before they can sell their product in Canada. Meanwhile, the manufacturer

and distributor of the product are required to obtain a Medical Device Establishment License (MDEL).

Our Services：

Application strategy consultation

Determine product classification

Testing services

Complete clinical assessments and design clinical protocols

Compile MDL application documents

Communicate with regulatory authority on your behalf

Complete the MDEL application

Regulatory correspondence services