Health Canada Medical Device Regulations (MDL, MDEL & SaMD)

Your most trusted consultant partner for Medical Device Compliance! Get support from former Health Canada specialists and rest assured that your devices adhere to Health Canada’s Medical Device regulations. Health Canada regulates medical devices to ensure they are safe, effective, and of high quality. Learn how these regulations are established and updated, and find out the additional requirements for commercially importing or selling a medical device in Canada.
Class 1 Medical Device FDA

Canadian Medical Device Classification Compliance in Canada

Medical devices in Canada cover health and medical instruments such as pacemakers, hip implants, artificial heart valves, thermometers, syringes, contraceptive devices, and medical laboratory diagnostic instruments.

Medical devices in Canada are classified into one of four classes. While Class I does not require any medical device license, Class 2, 3, and 4 do. All classes of medical devices in Canada must be manufactured under the Canadian medical device regulations.

Medical devices in Canada cover health and medical instruments such as pacemakers, hip implants, artificial heart valves, thermometers, syringes, contraceptive devices, and medical laboratory diagnostic instruments.

Medical devices in Canada are classified into one of four classes. While Class I does not require any medical device license, Class 2, 3, and 4 do. All classes of medical devices in Canada must be manufactured under the Canadian medical device regulations.

Medical Device License Regulations in Canada

Canada has one of the best regulatory systems in the world that make sure that medical devices sold in the country are safe, secure and effective. The Medical Device Regulations in Canada ensure that those companies that are engaged in manufacturing, labelling, packaging, and importing medical devices for sale are doing so in a compliant manner.

Understanding the Three Classes of Medical Devices

In Canada, medical devices are classified into three different classes: Class I, II, and III. Each class is based on the level of risk posed by the device; the higher the risk, the higher the class. Class I devices are generally low risk products such as bandages or syringes and require minimal regulatory control. Class II devices generally involve a moderate amount of risk such as some imaging tools or automated intravenous systems and require a bit more regulation. Finally, class III devices pose the greatest amount of risk, such as implantable defibrillators or heart valves, and require very stringent review and monitoring.

Medical Device Establishment License

A Medical Device Establishment License (MDEL) is required to manufacture, import, or distribute medical devices in Canada.

Suspension of an Establishment Licence

Any company failing to meet Health Canada’s medical device regulations or providing misleading statements in the application will have their establishment license suspended.

It’s important to note Health Canada has made it mandatory for firms to manufacture medical devices at a location that maintains quality standards such as ISO 13485 or equivalent in Canada. If a device is manufactured outside of Canada, then it must adhere to a quality standard and be brought into Canada by an importer who holds a Medical Device Establishment License (MDEL).
Medical Devices in Canada

Security and Quality Requirements for Class I, II and III Devices

As each class of medical device has a different risk level associated with it, they must also adhere to different security and quality requirements. Class I devices are typically subject to post-market surveillance in the form of incident reporting and require minimal documentation. Class II devices must have an appropriate Quality Management System as well as technical documentation such as instructions for use or pre-clinical evaluations. For class III devices, compliance with stringent regulatory controls is mandatory for approval and may involve pre-market clinical trials. Each class of device is subject to specific safety protocols stipulated by Health Canada in order to ensure the safety of patients using medical devices in Canada.

Registration or Licensing Requirements for Each Medical Device Class

In Canada, medical devices are classified into three different classes: Class I, II, and III. Each class is based on the level of risk posed by the device; the higher the risk, the higher the class. Class I devices are generally low risk products such as bandages or syringes and require minimal regulatory control. Class II devices generally involve a moderate amount of risk such as some imaging tools or automated intravenous systems and require a bit more regulation. Finally, class III devices pose the greatest amount of risk, such as implantable defibrillators or heart valves, and require very stringent review and monitoring.

Turnkey Medical Device Compliance Solutions in Canada

Quality Smart Solutions helps clients comply with the Canadian medical device regulations by providing solutions for licensing, regulatory review and label compliance. We offer customized solutions for firms to establish a renowned medical device manufacturing facility.

License Class Determination and Registration

Our compliance officers ensure your medical devices meet the Medical Devices Regulations and a license is issued so that your device is listed on Health Canada’s public website.

Medical Device Establishment License (MDEL) Registration

Get assistance from experts for manufacturing, distributing and importing medical devices. We help you meet ISO 13485 or 13488 standards to acquire a medical device establishment license (MDEL).

In Vitro Diagnostic Devices (IVD) Registration

Our experts can help you sell In Vitro Diagnostic (IVD) devices in Canada by providing assistance in registering and obtaining a Medical Device License (MDL) from Health Canada.

QIS MDEL Import Agent

We ensure that all devices that are brought into Canada are compliant with all the necessary regulations.

SaMD Classification and Registration

Register your medical device software with Health Canada with the help of our experts. Our professionals can help you determine your device’s risk evaluation, inclusion and exclusion criteria.

Labeling, Packaging, and Claims Requirements Across Medical Device Classes

Across the classes, labeling and packaging requirements change. For example, Class I includes the least stringent requirements with just a Generic name of the device necessary. Class III and IV, however, require detailed product information including brand names, batch numbers, expiration dates and more. In terms of making claims about the product, manufacturers should be aware that certain products must gain approval before they can be marketed as therapeutic or diagnostic devices in Canada. This applies to all devices classified under Class II and III devices as well as most Class IV Instruments.

Post-market Surveillance Strategies for Different Classes

Once a device has been approved, manufacturers must monitor public health and safety as product concerns may arise during its shelf life. Post-market surveillance is an important part of ensuring that medical devices continue to meet market needs and remain safe for consumers. In Canada, post-market surveillance strategies vary based on the classification of the device – Class I devices require minimal efforts but the scope of activity increases for higher classified devices such as those under Class II and III.

Devices we have licensed

We have licensed a wide range of medical devices, including but not limited:

PPE
Invitro Diagnostics
Monitoring Devices
Surgical Equipment
Mobile Aid
Radiology
Pacemakers
Personal Care

What are and who must comply with Health Canada Medical Device Regulations?

Health Canada Medical Device Regulations are a set of policies, laws, and guidelines designed to regulate the manufacture, sale, importation, and use of medical devices in Canada. They are intended to protect the health and safety of Canadian consumers by ensuring that any medical device sold or distributed in the country meets minimum standards for quality, safety, and efficacy. It is important to understand these regulations so you can remain compliant with the law when selling or distributing medical devices.  All stakeholders involved with medical devices must comply with Health Canada Medical Device Regulations. This includes manufacturers, laboratories, importers, and distributors who have obtained licenses from Health Canada. In addition, any individual or organization that sells or distributes medical devices to Canadians must be aware of the requirements specified in the regulations and abide by them to remain compliant.

How to Register Your Regulation Compliant Medical Devices in Canada?

To register a medical device with Health Canada in accordance with the applicable Medical Device Regulations, companies must submit an application for registration that includes basic business and product information, as well as supporting documents. The completion of all registration requirements depends on the risk class assigned to the device and may require additional evaluations or tests. Furthermore, companies are required to provide an accurate description of their devices and relevant studies that demonstrate compliance with applicable regulations before their products can be registered.

Frequently Asked Questions

Medical device compliance ensures that your medical devices and establishments are manufactured, labelled and licensed appropriately in order to manage the risk posed to public health and safety.

Your medical device needs to be licensed prior to sale in Canada. Our team of experts can help license your Class II, III or IV medical device.

The term Medical Device, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.
Health Canada is the federal regulator of therapeutic products, including medical devices. Specifically, the Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate at Health Canada is the Canadian federal regulator responsible for licensing medical devices in accordance with the Food and Drugs Act and Regulations and the Medical Devices Regulations.
As per section 6 of the Medical Device Regulations, medical devices are classified into one of four classes where Class I represents the lowest risk devices and Class IV the highest risk devices.

A Medical Device Establishment Licence (MDEL) is a licence issued to manufacturers of Class I medical devices as well as importers or distributors of all device classes. The MDEL permits businesses to import or distribute a medical device in Canada. An MDEL provides Health Canada assurance that medical devices sold or imported into Canada meet the safety requirements set out in the Medical Devices Regulations, and that procedures are in place to protect the public should a problem with a device be identified. The MDEL listing contains information about the licensed establishment including their company ID, licence number, company name, address, authorized activities and associated class of device(s).

  • PPE
  • In vitro Diagnostics
  • Monitoring Devices
  • Surgical Equipment
  • Mobile Aid
  • Radiology
  • Pacemakers
  • Personal Care items

Do you know?

Follow Latest News, Blogs & Industry Updates
Need Medical Device Compliance Assistance Today

Please complete the form below. We will respond to you soon.

Select all applicable Services
Select countries of interest
5/5 (1 Review)
This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.