Medical Devices Establishment Licence Listing (MDEL)
The intent of the MDEL requirements in the Regulations is:
- To ensure that the Inspectorate is made aware of:
- persons importing and/or distributing medical devices in Canada (including distributors located outside Canada who are selling to Canadian facilities),
- manufacturers of medical devices sold by the holders of MDELs (licence holder), as well as the classification of those devices,
- manufacturers of Class I devices who distribute their own devices.
- To require licence holders to provide some assurance to the Inspectorate that they have met the regulatory requirements and have documented procedures in place, where applicable, related to distribution records, complaint handling, recalls, mandatory problem reporting and for handling, storage, delivery, installation, and servicing, with respect to the medical devices they sell.
Source : http://www.hc-sc.gc.ca/
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