Medical Device License | MDEL Health Canada | MDEL Registration & Renewals

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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Introduction to Medical Device Establishment Licenses (MDELs)

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.

Health Canada MDEL Requirements for Importing or Distributing Medical Devices

Class I to IV Medical Devices

If you distribute or import class I to IV medical devices including covid antigen or molecular test kits, you require an MDEL.

Class I Medical Devices

If you manufacture class I medical devices in Canada (eg. shields, masks, gowns, toothbrushes, etc.), you require an MDEL.

Foreign Businesses

If you manufacture, market or distribute medical devices to Canadian resellers from any other country (businesses outside Canada), you require an MDEL.

Medical Devices related to COVID-19

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).

Quality System Requirements for MDEL Health Canada

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:

  • The testing device registered with Health Canada under interim order or permanent medical device license. If the device is not registered then this process must happen first before importation and/or distribution is permitted.
  • If you intend to import and sell directly to consumers you will need a medical device establishment license (MDEL)
  • If you intend to resell these devices to a retailer or reseller,  you must obtain an MDEL with the distributor activity (note that one MDEL can cover one or more activities ie. importing and/or distributing)
  • As an MDEL holder you must follow the practices and procedures based on the respective activities you plan to conduct. Standard Operating Procedures are required for your business.
  • If your business generates revenue under $5 million you may qualify as a small business and your Health Canada application fees will be reduced by approximately 25%
  • Health Canada fees for an MDEL are due before license issuance (Health Canada will notify you via email) and an annual renewal fee is due when you submit your license renewal each year by April 1. Please note that MDEL fees are not prorated.
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What is the cost of obtaining a Medical Device Establishment License? MDEL Solutions

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 set by Health Canada and increases annually indexed to inflation., while the application fee for a Class II to IV MDEL is varies by class and also increases annually. 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 cost of obtaining an MDEL is essential when planning to bring a medical device to the Canadian market.

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What are the types of Medical Device Establishment Licenses?

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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Launching Your Medical Device in the United States?

FDA Medical Device Licensing Renewal and Facility Registration Solutions

510(K) Pre-Market Notification

Help you register your medical devices, if required through a 510(k) pre-market notification.

Medical Device Facility Registration

We will register your device facility or activity through a secure online FDA portal.

Medical Device Label Compliance

Ensure your label adheres to FDA medical device label regulations as per applicable 21 CFR sections.

Trusted US Agent

We will act as your most trusted US Agent for your registered medical device facility.

Medical Device Regulations (MDEL & MDL) - Frequently Asked Questions

  1. If you distribute or import class I to IV medical devices (including COVID-19 antigen test kits) you require a Medical Device Establishment License (MDEL).
  2. If you manufacture Class I medical devices in Canada (eg. shields, masks, gowns, toothbrushes, etc.), you require an MDEL.
  3. 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.

  • The testing device is registered with Health Canada under interim order or permanent medical device license. If the device is not registered, then this process must happen first before importation and/or distribution is permitted.
  • If you intend to import and sell directly to consumers, you will need a medical device establishment license (MDEL)
  • If you intend to resell these devices to a retailer or reseller, you must obtain an MDEL with the distributor activity (note that one MDEL can cover one or more activities i.e. importing and/or distributing)
  • As an MDEL holder you must follow the practices and procedures based on the respective activities you plan to conduct. Standard Operating Procedures are required for your business.
  • If your business generates revenue under $5 million you may qualify as a small business and your Health Canada application fees will be reduced by approximately 25%
  • Health Canada fees for an MDEL are due before license issuance (Health Canada will notify you via email) and an annual renewal fee is due when you submit your license renewal each year by April 1. Please note that MDEL fees are not prorated.
  • You must follow good practices by adhering to procedures and generating records
  • As an MDEL holder, you must answer a series of questions from Health Canada
  • You must provide responses in 3 to 5 business days.
  • Health Canada conducts remote/virtual assessments of MDEL holders as soon as the MDEL is obtained.
  • You must present copies of standard operating procedures related to MDEL activities
  • We can confirm the class of your medical devices anddetermine whether a license is required, and confirm if they qualify for fee exception
  • We will collect important information, such as device details, manufacturer quality systems qualifications, global market history, clinical or non-clinical evidence,
  • etc
  • We can help prepare the MDL application and, if applicable, a dossier to support your device
  • We can act as your regulatory correspondent with Health Canada to answer questions on your behalf
  • We can prepare and submit your MDEL application and answer all questions asked by Health Canada
  • We can develop and write SOPs for your MDEL activities to ensure you have the foundational procedures to establish a sound quality management system
  • We submit a small business fee reduction application form in case your business qualifies as a small business
  • After you are licensed, we can conduct a routine audit of your activities and review standard operating procedure updates
  • We can help complete and submit the MDEL Renewalapplication (ALR package) before April 1
  • We will confirm if all supporting documents are complete and if there have been any changes to your activities since the last renewal
  • We will evaluate and verify all the information to avoid refusal
  • We will check if any product for which licenses are listed has not been withdrawn from the Canadian market

The MDEL is issued by Health Canada for activities of manufacturing, importing, or distributing medical devices for use in Canada. 

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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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