About medical devices

How medical devices are licensed and monitored in Canada.

On this page

• What are medical devices
• How medical devices are licensed and regulated
• Types of licences for medical devices, by class
• Safety of medical devices after licensing
• Reporting medical device problems
• Action Plan on Medical Devices

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:

• medical device licences (MDL)
• medical device establishment licences (MDEL)

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:

• the risks have been reduced as much as possible
• the benefits outweigh the potential risks of the use of the device

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:

• note changes that may affect a device's expected benefits and risks
• conduct inspections to ensure a company is complying with the Food and Drugs Act and the Medical Devices Regulations
• monitor devices through recalls, complaints and problem reports from consumers, health care professionals, industry stakeholders and other sources

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
• importers
• distributors

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

The MDEL:

• helps identify companies that are selling medical devices in Canada
• ensures standards and procedures are in place to mitigate health and safety risks
• helps identify who manufactured the devices being sold by the MDEL holder

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:

• storage
• handling
• installation
• delivery
• service (when applicable)

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:

• scientific literature
• reports of medical device problems
• information shared by international regulators
• input from health care professionals and users
• information that we have requested from the manufacturer
• other relevant information that becomes available

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:

• informing health care professionals and consumers
• requiring the manufacturer to update the device's design or label
• restricting the use of a device for people who are considered to be at higher risk
• stopping the sale of the medical device

We also:

• inform Canadians about inspections and advertising complaints
• issue notices when there is an advisory, safety review or new safety information on a medical device
• maintain a medical device incident database, which contains medical device incident reports and recall information

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:

• recall the medical device
• seize an unlicensed device
• request a label change
• issue a stop sale letter
• refuse importation of the device
• control the distribution of the device

In the most severe cases, we may:

• suspend or cancel the product (MDL) or establishment (MDEL) licence
• seek an injunction
• prosecute the company

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:

• does not work
• is counterfeit
• becomes less effective
• is hard to use or has confusing instructions
• has caused harm or could potentially cause harm

Trade complaints by companies are also considered voluntary complaints.

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

• completing the form below

or

• calling toll-free at 1-800-267-9675

We review all reports and follow up by:

• seeking more details from the person who submitted the voluntary report when necessary
• communicating with the manufacturer, importer or distributor to verify compliance, if required

Mandatory reporting

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

• hospitals
• importers
• manufacturers
• health care professionals using devices under the special access or investigational testing programs

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:

• hospitals to report a medical device incident within 30 days (as of December 16, 2019)
• companies to provide more information on the safety and effectiveness of their devices
• doctors using a medical device under the Special Access Programme to report a serious problem within 72 hours

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

Related links

• Policies
• Standards
• Quality systems
• About medical device problems
• Food and Drugs Act liaison office
• Recalls and safety alerts database
• The Drug and Health Product Register
• Clinical information on drugs and health products
• Mandatory Problem Reporting for Medical Devices – Guidance Document
• Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary
• Mandatory Reporting of Serious Adverse Drug Events and Medical Device Incidents by Hospitals – Guidance Document