About medical devices

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How medical devices are licensed and monitored in Canada.

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What are medical devices

A medical device is any instrument or component used to treat, diagnose or prevent a disease or abnormal physical condition. Medical devices don't include those used for animals or for veterinary purposes.

Types of medical devices

Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and pacemakers. They also include diagnostic devices, such as cancer screening tests, blood glucose monitors and pregnancy test kits.

In Canada, medical devices are grouped into 4 classes based on the expected level of risk to a person's health and safety. Class I medical devices (e.g., a thermometer) pose the lowest risk to users. Class IV medical devices (e.g., a pacemaker) pose the highest risk.

How medical devices are licensed and regulated

Licensing of medical devices

We issue 2 types of licences in Canada:

MDLs are issued for Class II, III and IV medical devices. MDELs are issued to companies that import (Class I to IV), distribute (Class I to IV) or manufacture (Class I) medical devices.

As Class III and IV medical devices pose the highest level of risk, applications for licensing must contain evidence of their clinical effectiveness. Such evidence includes clinical trials, clinical reviews, meta-analyses and real-world evidence reviews.

Once a device receives the appropriate medical device licence, it can be distributed in Canada.

Regulating and monitoring medical devices

Like all health products, medical devices have benefits and risks. Our licensing system means:

Also, our regulatory system for medical devices is one of the most stringent in the world.

All medical devices distributed in Canada undergo a combination of scientific review, monitoring, compliance and enforcement activities. For example, we:

Types of licences for medical devices, by class

Medical device establishment licence (MDEL) for Class I medical devices

A medical device licence isn't required for Class I devices.

However, to import or sell a Class I device, a medical device establishment licence (MDEL) is required for:

Manufacturers that import or sell solely through a company that holds an MDEL are exempt.


To receive an MDEL, companies must have established written procedures to demonstrate they can respond to complaints and conduct recalls if required. Manufacturers and importers must have procedures in place for reporting recalls and serious medical device problems to Health Canada. (Note: importers and distributors must have an MDEL to import or sell all classes of medical devices.)

You can check the names of companies that hold an MDEL in Canada in the MDEL database.

Medical device licence (MDL) for Class II, III and IV medical devices

Class II, III or IV medical devices cannot be sold or imported in Canada without a valid medical device licence (MDL). Unlicensed devices that haven't been assessed for their safety, effectiveness and quality may pose a health risk to Canadians.

You can check the Medical Devices Active Licence Listing for all licensed medical devices in Canada.

Manufacturers must apply for an MDL for medical devices that fall under Classes II to IV.

Companies that import or distribute Class II, III or IV medical devices must have procedures in place that outline processes for:

Onsite inspections are conducted in Canada and abroad to confirm compliance.

Safety of medical devices after licensing

Canadians use medical devices in different situations or for long periods of time. For these reasons, devices need to be re-evaluated, as important new information about the safety, effectiveness and quality of a device may need to be considered.

Medical devices licensed for sale in Canada are monitored for their ongoing safety, effectiveness and quality in various ways.

We watch for any changes to the expected benefits and risks of licensed medical devices by assessing:

Health Canada encourages consumers to report problems involving medical devices, including the sale of unauthorized devices. Consumers are encouraged to report the information they have, even if they're uncertain of all the specific details needed.

When there is a safety issue related to the use of a medical device, we will take the appropriate action. This may include:

We also:

Inspection, compliance and enforcement

Health Canada inspects companies that sell, distribute and import devices. We also inspect manufacturers of Class I devices. You can learn more about the medical device inspections we conduct and the results.

We regularly inspect licence holders to make sure they are complying with the Food and Drugs Act and the Medical Devices Regulations. In cases of non-compliance, we will take action based on the level of risk posed.

The compliance and enforcement action taken depends on the risk posed to the health of Canadians. For example, we may:

In the most severe cases, we may:

We may also take these types of actions when we are following up on mandatory or voluntary problem reports and complaints.

We are continuously working to strengthen our compliance and enforcement strategy to help ensure the quality and safety of medical devices.

Reporting medical device problems

Canadians are encouraged to submit a voluntary report if their medical device:

Trade complaints by companies are also considered voluntary complaints.

We encourage you to report problems and trade complaints involving medical devices by:


We review all reports and follow up by:

Mandatory reporting

A number of groups are required to report serious problems with medical devices to Health Canada. These groups are:

For more information on how to submit a mandatory report, see Report a medical device problem.

Action Plan on Medical Devices

We are continuously working to improve the safety, effectiveness and quality of medical devices for your health. Our 3-part action plan:

  1. improves how devices get on the market through enhanced safety, effectiveness and quality measures
  2. strengthens the monitoring and follow-up of devices being used by Canadians
  3. provides more information to Canadians about the medical devices they use or will use

These actions and others will strengthen our authority by requiring:

Device Advice: e-Learning tool Understanding How Medical Devices are Regulated in Canada – Premarket Regulation

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