Safe medical devices in Canada

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What are medical devices

The term "medical device" covers a wide range of medical instruments used to treat, reduce, diagnose or prevent a disease or abnormal physical condition. Some examples include:

  • hip implants
  • pacemakers
  • synthetic skin
  • artificial heart valves
  • test kits for diagnosis
  • contraceptive devices
  • medical laboratory diagnostic instruments

Regulating medical devices

The Medical Devices Directorate (MDD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.

MDD ensures that medical devices sold in Canada meet safety, effectiveness and quality requirements. This is done by a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process.

Medical device licence

In Canada, certain devices must have a medical device licence before they can be sold. To determine which devices need a licence, all types of medical devices have been categorized based on the risk associated with their use. This approach means that all medical devices are grouped into 1 of 4 classes. Class I devices (such as a wheelchair) present the lowest potential risk. Class IV devices (such as a pacemaker) present the greatest potential risk.

Before they can sell a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device licence. Although Class I devices do not require a licence, they are monitored through the establishment licensing process.

Review process

There are a few steps involved when a company decides that they would like to bring a medical device to market in Canada:

  1. manufacturer submits an application for a medical device licence
  2. the amount of information needed depends on the class of the device
  3. MDD reviews the application
  4. MDD issues a licence if the information provided meets the requirements of the Medical Devices Regulations

If MDD decides not to issue a licence, the manufacturer may re-submit an amended revised application (with the additional information) or appeal the decision.

The time it takes to review an application depends on the class of the device:

  • Class II licence applications: 15 calendar days
  • Class III licence applications: 75 calendar days
  • Class IV licence applications: 90 calendar days

Establishment licence

A medical device establishment licence (MDEL) permits the following to sell medical devices in Canada:

  • manufacturers of Class I devices who do not sell their devices through a licenced importer or distributor
  • importers and distributors (of any class of device)

Establishment licensing ensures that Health Canada knows the identity of establishments that are selling or manufacturing medical devices. Establishments must also give assurance to us that they have met the regulatory requirements for post-market activities.

Post-market surveillance

MDD plays a role in monitoring medical devices after they're licensed to ensure they continue to meet safety and effectiveness requirements. If a medical device is found to no longer meet safety and effectiveness requirements, we may suspend its licence or ask the manufacturer to recall or refit the medical device.

Special access program

Health care professionals may use the special access program (SAP) to gain access to medical devices that have not been licensed in Canada. SAP is used in emergencies or when conventional therapies have failed, are unavailable or are unsuitable to treat a patient.

For more information, please refer to our special access programs: Request access to a medical device.

Contact us

Medical Devices Directorate
Health Products and Food Branch
11 Holland Ave, Tower A, 2nd Fl
Address Locator: 3002A
Ottawa ON K1A 0K9
Telephone: 613-957-7285
Email: meddevices-instrumentsmed@hc-sc.gc.ca

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