Medical Device Establishment Licence (MDEL) Solutions for Canada Overview
Medical Device Establishment Licence (MDEL) is a licence issued by Health Canada (HC) to oversee medical devices in the Canadian market. Its main aim is to guarantee that medical devices sold/imported into Canada adhere to the safety standards outlined in the Canadian MDR (MDR SOR/98-282) and the standards and establishments maintain records, address complaints, manage recalls, report incidents, and promptly update Health Canada about any changes.
Who Needs an MDEL?
Manufacturers of Class I medical devices intended to import/sell for the Canadian market must obtain an MDEL.
Importers who import medical devices from a manufacturer and/or supplier outside of Canada and sell them in Canada.
An importer is any person in Canada, other than the manufacturer, who is responsible for the medical device coming into Canada.
Importers must ensure that the device they are bringing into Canada is compliant with all necessary regulations. Non-compliance can result in monetary losses and reputational damage.
The importer must have procedures in place to handle complaints and device recalls.
The importer must submit an annual licence review application each year and notify Health Canada of any changes to their information.
Distributor who buys medical devices from a manufacturer and/or supplier (importer or distributor) in Canada and sells them in Canada to someone other than the ultimate consumer.
Requirements for Issuing an MDEL:
Class I manufacturers and importers/distributors must have documented procedures for complaints and recalls obtaining an MDEL. Meanwhile, manufacturers of Class I devices can import their products without an MDEL as long as their importers and distributors hold valid MDELs.
Streamline your Medical Device Establishment Licensing process with our expert support. Contact Freyr's specialists today to ensure your medical device meets all the Regulatory requirements and gains timely market access in Canada.
Freyr Medical Device Establishment Licence (MDEL) Competencies:
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Health Canada medical device classification and grouping services.![]()
Gap analysis of the source documents.![]()
Review the availability of mandatory procedures as per Health Canada MDR.![]()
Preparation of Medical Device Establishment Licence (MDEL) application.![]()
Submission of Medical Device Establishment Licence (MDEL) application to Health Canada.![]()
Support to address the queries from Health Canada.
Frequently Asked Questions (FAQs)
Yes, foreign manufacturers are able to market Class I medical devices in Canada without holding an MDEL provided if their importer/distributor holds an MDEL.
An MDEL is a licence granted to the manufacturer, distributor, or importer, whereas an MDL is an approval provided by Health Canada for Class II, III, or IV medical devices.
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