Understanding MDEL Health Canada guidelines is critical for companies who manufacture and ship medical devices, such as pacemakers or insulin pumps. This guide will give a comprehensive overview of the MDEL Health Canada regulations, including an explanation of the provisions and how to stay in compliance with them.
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? Health Canada MDEL Annual License Review (ALR) was due by April 1, 2022. If you didn’t renew and need assistance with filing your MDEL application, contact us today. Contact us to renew your license this year before 2023.
A Medical Device Establishment Licence (MDEL) is an authorization granted by Health Canada to a person in order to manufacture, import, advertise or sell medical devices in Canada. It is important to understand MDELs and the benefits they provide to enable companies to stay compliant with the medical device regulations among other requirements. The Canadian regulatory system guarantees that only authorized individuals can design, manufacturer, advertise and distribute medical devices in the country to ensure safety and quality assurance.
As an MDEL holder, you must ensure that all medical devices manufactured, imported, sold or advertised meet the safety and effectiveness requirements of Health Canada. Additionally, you must also keep records of all processes necessary for quality assurance and use the MDEL label appropriately on the medical device. Furthermore, to stay compliant with certain provisions, you must report any incidents related to the device or other malfunctions to Health Canada.
If you distribute or import class I to IV medical devices including covid antigen or molecular test kits, you require an MDEL.
If you manufacture class I medical devices in Canada (eg. shields, masks, gowns, toothbrushes, etc.), you require an MDEL.
If you manufacture, market or distribute medical devices to Canadian resellers from any other country (businesses outside Canada), you require an MDEL.
Covid-19 test kits, either antigen or molecular (PCR) based, are In-Vitro Diagnostics Tests (class IV) devices. These test kits can be registered faster under the Interim Order Authorization pathway (IO). Health Canada has published a list of medical devices that have received interim order Authorization.
Click Here to See the List of Authorized COVID-19 Related Testing Devices by Health Canada.
This infographic summarizes the most sought after medical devices and their respective classifications. Please note that Health Canada
has issued an ‘Interim Order’ which helps expedite the approval of medical devices for sale in Canada.
Please note that fees for medical devices are currently waived (however, fees for medical device establishment licenses ie. MDEL, are not waived).
All MDEL applications must include a Quality System file outlining the overall system in place for evaluating the complete device. This section should provide detailed information regarding the inspecting and testing process, equipment used, and the personnel involved. Moreover, companies must also provide evidence of their compliance with European CE Marking requirements if applicable. The Quality System file must explain any deviations from these requirements as part of their MDEL application.
When submitting an MDEL application to Health Canada, companies must provide a complete registration package. This must include information related to the device’s safety, performance, design and other related documentation. Additionally, a fee must be submitted with the application which is determined on a case-by-case basis depending on the complexity of the evaluation process. Once accepted, Health Canada issues an MDEL number that confirms the device meets all evaluation criteria and is eligible for sale in Canada.
To bring Covid test kits into Canada, you will need the following:
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Covid-19 test kits, either antigen or molecular (PCR) based, are In-Vitro Diagnostics Tests (class IV) devices. These test kits can be registered faster under the Interim Order Authorization pathway (IO). Health Canada has published a list of medical devices that have received interim order Authorization.
The MDEL is issued by Health Canada for activities of manufacturing, importing, or distributing medical devices for use in Canada.
NOTE: Class II, III and IV medical devices in Canada require that the manufacturer of the device have an MDSAP (Medical Device Single Audit Program) before the device application can be filed with Health Canada.
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