Don't risk your Health Canada MDEL, MDL, or SaMD & Get Licensed Faster

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.

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.

Canadian Medical Device Classification | Regulatory Experts save you Time & Money

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, Classes 2, 3, and 4 do. All classes of medical devices in Canada must be manufactured under Canadian medical device regulations.  We can guide you through the MDEL listing, the MDEL licensing process, medical device regulations, and what an MDL costs.

Understanding the four classes of Medical Devices

In Canada, medical devices are classified into three different classes: Class I, II, III and IV. 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, latex gloves, electric toothbrush or automated intravenous systems and require a bit more regulation. Class III devices pose medium to high risk, such as an MRI imaging equipment, hip replacement implants or other devices that are in the body for at least 30 consecutive days.  Class IV medical devices pose the highest risk 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

Everything you should know about licensing & labeling Medical Devices in Canada?

The main steps include preparing a medical device licence application, submitting it to Health Canada, undergoing a review process, and receiving the licence if the application is approved. An MDEL is a separate license required for businesses that import or distribute medical devices in Canada. It is essential for importing and distributing medical devices legally. The processing time for an MDL application can vary depending on factors such as the device’s classification, complexity, and the completeness of the submission. Medical device labeling in Canada should be in both English and French. It should include essential information, such as device name, manufacturer details, and instructions for use. Manufacturers must report adverse events and safety issues related to their devices to Health Canada as part of post-market surveillance obligations. MDLs must be renewed periodically, typically every five years. Manufacturers should also update their licences when there are changes to the device or its labeling. A Canadian Authorized Representative (CAR) is a Canadian entity that represents foreign manufacturers for regulatory purposes. They assist with MDL applications and ensure compliance with Canadian regulations.

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.

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

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

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