Medical Device Licence (MDL) Solutions for Canada Overview
A Medical Device Licence (MDL) is a document issued by Health Canada (HC) that authorizes manufacturers to import or sell Class II, III, or IV medical devices in Canada. The licence ensures that the devices meet the necessary safety, quality, and efficacy standards as per the Medical Devices Regulations.
Who Needs an MDL?
Manufacturers of Class II, III, and IV medical devices intended to import/sell in the Canadian market must obtain an MDL.
Requirements for Issuing an MDL:
The manufacturers shall comply with the Medical Device Regulations (MDR) of Health Canada, to obtain an MDL.
- All Class II, III, and IV device manufacturers must have an ISO 13485:2016 certificate under the Medical Device Single Audit Program (MDSAP). This demonstrates compliance with Quality Management System (QMS) requirements to receive Health Canada approval issued by Health Canada authorized Conformity Assessment Bodies (CAB), which is a pre-requisite to apply for an MDL.
- An MDL application form must be submitted to Health Canada for each Class II, III, or IV device.
- The private labelers can apply for MDL only after the original manufacturer is issued an MDL.
- The application form for the private labelers is different from that of the original manufacturers.
Streamline your Medical Device 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 Licence (MDL) Competencies:
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Health Canada medical device classification and grouping services.![]()
Review and compilation of gap analysis of the source documents.![]()
Compilation and review of the technical dossier.![]()
Preparation of Medical Device Licence (MDL) application.![]()
Labeling services as per Health Canada labeling requirements for medical devices.![]()
Reviewing of the labeling documents.![]()
Submission and interaction with Health Canada compliance approval of the product.![]()
Medical Device Single Audit Program (MDSAP).
Frequently Asked Questions (FAQs)
To obtain a Medical Device Licence (MDL), you need to submit an application to Health Canada. This application must include comprehensive information about the medical device, its intended purpose, and supporting documentation. Essential documents typically comprise clinical data, safety testing outcomes, and certification of the Quality Management System (QMS).
If you have an existing Medical Device Licence (MDL) and need to report changes to their address or other significant modifications, you must notify Health Canada. This is done by submitting an amendment form along with a summary of the changes from the originally approved details.
To apply for a Medical Device Licence (MDL), companies must demonstrate they have a Quality Management System (QMS) certified under ISO 13485: 2016 through the Medical Device Single Audit Program (MDSAP). This system must comply with the specific standards outlined in the Canadian Medical Devices Regulations (CMDR).
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