Health Canada Medical Device License (MDL) and MDEL Registration
With more than 1000 medical device manufacturing facilities a strong presence in the medical device. Market with about 60% of their imports coming from the United States 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 procurement management with the Canada license Applications Medical Devices Regulations (CMDR). The specialists have experience in quality system evaluation 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) the Medical Device License (MDL) for Canada.
Health Canada Medical Device Establishment License (MDEL)
If manufacturers of Class I In Vitro diagnostic devices (IVDs) medical devices want to sell directly into Canada, they must acquire a Medical Device Establishment License (MDEL). they market their products through a licensed (MDEL) distributor in Canada. Medical device distributors importers must receive an MDEL irrespective of product classifications. A MDEL is a Manufacturer, distributor, importer’s own authorization. MDEL is not required for manufacturers of medical devices of classes II, III , IV.
Health Canada Medical Device License (MDL)
For every Class II, III and IV manufacturers in Canada License Application, a Canadian Medical Device License (MDL) is required. The Canada License Applications Medical Device License (MDL) is equivalent to the US FDA 510(k) process. The process of obtaining an MDL is faster Class II FDA, for Class III devices approximately the same time, for Class IV it is more complicated.
E & E Medicals and Consulting help its clients understand comply with Canada’s medical device regulations. We will work closely with you to determine how your device is classified prepare the necessary to meet Canadian medical device regulations.