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. Check out our ultimate and step-by-step guide for obtain your Medical Device Establishment License.
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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.
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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Obtaining a Medical Device Establishment License (MDEL) can be costly. The cost of getting an MDEL will depend on various factors, including the classification of your medical device and the complexity of your application. The application fee for a Class I MDEL is currently $1,160, while the application fee for a Class II to IV MDEL is $4,640. In addition to the application fee, additional costs may be associated with regulatory compliance, such as clinical trials, product testing, and quality system development. Budgeting for the high cost of obtaining an MDEL is essential when planning to bring a medical device to the Canadian market.
Health Canada can issue two types of Medical Device Establishment Licenses (MDEL). The first type is a Class I MDEL, given to companies that import, distribute, or sell low-risk medical devices. The second type is a Class II to IV MDEL, issued to companies that import, distribute, or sell medium- to high-risk medical devices. The classification of medical devices is based on their level of risk. Medium- to high-risk devices, such as pacemakers and artificial joints, are classified as Class II to IV devices. Low-risk devices, such as bandages and tongue depressors, are classified as Class I devices.
The classification of a medical device determines the regulatory requirements that must be met before it can be sold in Canada. Higher-risk devices require more stringent regulatory requirements, including clinical trials and pre-market reviews. Lower-risk devices may only require product labeling and advertising reviews.
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We will register your device facility or activity through a secure online FDA portal.
Ensure your label adheres to FDA medical device label regulations as per applicable 21 CFR sections.
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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.
