Health Canada Medical Device License (MDL) and MDEL Registration
With more than 1000 medical device manufacturing facilities and a strong presence in the medical device market with about 60% of their imports coming from the United States and other regions of the world, all medical devices sold into the Canadian market must comply with Canadian medical device regulations.
Medical Device Consulting Services for Canada
E & E Medicals and Consulting assists manufacturers of medical devices in obtaining health Canada regulatory approval. We counsel clients on issues related to quality assurance, regulatory compliance and procurement management with the Canadian Medical Devices Regulations (CMDR). The specialists have experience in quality system evaluation and implementation that supports the company in compliance with MDR regulations. Medical device manufacturers may need a license to enter the Canadian market. Health Canada grants two forms of licenses: The Medical Device Establishment License for Health Canada (MDEL) and the Medical Device License (MDL) for Canada.
Health Canada Medical Device Establishment License (MDEL)
If manufacturers of Class I or In Vitro diagnostic devices (IVDs) medical devices want to sell directly into Canada, they must acquire a Medical Device Establishment License (MDEL). However, they could also market their products through a licensed (MDEL) distributor in Canada. Medical device distributors and importers must receive an MDEL irrespective of product classifications. A MDEL is a Manufacturer, distributor, or importer’s own authorization. MDEL is not required for manufacturers of medical devices of classes II, III and IV.
Health Canada Medical Device License (MDL)
For every Class II, III and IV manufacturers in Canada, a Canadian Medical Device License (MDL) is required. The Canadian Medical Device License (MDL) is equivalent to the US FDA 510(k) process. The process of obtaining an MDL is usually faster than the Class II FDA, for Class III devices approximately the same time, and for Class IV devices it is more complicated.
E & E Medicals and Consulting help its clients understand and comply with Canada’s medical device regulations. We will work closely with you to determine how your device is classified and prepare the necessary documentation to meet Canadian medical device regulations.