Regulatory requirements for importing medical devices

On this page

• What is commercial importation
• Who can import
• Unlicensed and counterfeit medical devices
• Compliance and enforcement actions
• Contact us

Medical devices are products used to treat, mitigate, diagnose or prevent a disease or health condition in people. They are grouped into 4 classes. Class I devices pose the lowest potential health risk, while Class IV devices pose the highest potential health risk. For more information on the types of devices in each class, visit our medical devices page.

What is commercial importation

Medical devices imported into Canada for sale, with or without a monetary contribution, must meet Health Canada requirements for commercial importation, as outlined in the Food and Drugs Act (FDA) and the Medical Devices Regulations (MDR).

The importation of a medical device that requires direct oversight, operation or administration by another person is a commercial importation.

Examples of commercial importation of medical devices include shipments:

• to a retailer, distributor or other commercial establishment
  • includes shipments to independent sales contractors and distributors or to health care practitioners for use in their practice
• with other materials to be used for advertising or promotion
• destined for export sale

Who can import

An importer is any person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device coming into Canada. Anyone who imports a medical device into Canada must also meet all applicable requirements of the FDA and associated Regulations. Some requirements include the following:

• Class I device: The importer must have a valid Medical Device Establishment Licence (MDEL) with the activity of import, unless exempted
• Class II, III or IV device: The device must be licensed by having a Medical Device Licence (MDL) and the importer must have a valid MDEL with the activity of import, unless exempted
• All medical device classes: The importer must ensure that the company from whom they import (foreign distributor) has an MDEL that includes the appropriate licensable activities, unless exempted

Exemptions

Importers are exempt if they are a:

• retailer/company that only sells directly to the end user for their own personal use
• health care facility
• Class I medical device manufacturer that imports only Class I medical devices through someone else who has an MDEL
• manufacturer of Class II, III or IV medical devices that only sells:
  • medical devices for which they hold a valid licence or
  • custom-made medical devices, medical devices for special access or medical devices for investigational testing involving humans for which a valid authorization has been issued
• person who only imports or sells veterinary medical devices
• Dispenser (member of a recognized professional association who can make or adapt a medical device for a particular patient in accordance with a professional's written direction in order to meet the specific requirements of a patient)
• person who only imports or sells custom-made medical devices (manufactured only for a particular patient in accordance with a professional's written direction), medical devices for special access or medical devices for investigational testing involving humans, for which a valid authorization has been issued

Foreign distributors or manufacturers of any class of medical device offered for sale in Canada must have an MDEL, unless:

• Class I device is imported by an MDEL holder from the foreign manufacturer of that medical device
• Class II, III or IV medical device is imported from the foreign manufacturer of that medical device
• the foreign distributor (foreign exporter that is not the manufacturer) sells medical devices (all classes) exclusively to an MDEL holder in Canada

For detailed guidance on requirements for an MDEL, see table 1 of the guidance on medical device establishment licensing (GUI-0016).

To verify if an importer, foreign distributor or foreign manufacturer has a valid MDEL, see our medical devices establishment licence listing database.

To verify if a medical device holds a valid MDL, see our medical devices active licence listing database. Class I medical devices are not required to hold an MDL and are not listed in this database. To verify a class of medical device, see the keyword index in the guidance for industry.

Unlicensed and counterfeit medical devices

Our Medical Devices Directorate (formerly the Medical Devices Bureau) helps to ensure the safety, effectiveness and quality of medical devices sold in Canada. The Medical Devices and Clinical Compliance Directorate in the Regional Operations and Enforcement Branch conducts compliance and verification activities once a device is on the Canadian market.

Unlicensed, or counterfeit, devices have not been assessed for safety, quality or effectiveness by Health Canada. A counterfeit device can be mistaken for an authentic, licensed product.

Counterfeit medical devices may include:

• similar ingredients or components to a licensed device
• the wrong ingredients or components
• inactive or insufficient ingredients

They may also have misleading packaging or labelling.

A medical device is counterfeit when it:

• has fraudulent components, parts and accessories
• is fraudulently labelled as to its identity, composition, origins and/or source
• has false features that appear genuine

Counterfeit medical devices pose a health and safety risk to Canadians. The health risk may be low or high, resulting in hospitalization or even death.

These counterfeit devices also:

• compromise the reputation of genuine brands
• reduce consumer confidence in the supply chain

Unlicensed and counterfeit health products and associated activities violate the FDA and its Regulations. All applicable FDA and MDR requirements must be met at the time for importation into Canada of medical devices.

Compliance and enforcement actions

We work with the Canada Border Services Agency to prevent the importation into Canada of medical devices that do not comply with the FDA and the MDR.

Our compliance and enforcement policy for health products (POL-0001) outlines the actions Health Canada can take to prevent or address non-compliance or address a public health and safety issue. These include:

• recommending the refusal or seizure of imports at the border
• ordering the removal or destruction of imports at the border
• asking an importer to take corrective measures on a product under certain conditions or consent to its removal from Canada or to its forfeiture

Contact us

For more information about the import requirements of medical devices, contact Border Centres of Health Canada:

• Toll free (Canada and USA): 1-833-622-0414
• From outside Canada : 204-594-8061
• Email: hc.healthproduct-import-produitsante.sc@canada.ca

For more information about MDLs, contact the Medical Devices Directorate:

• Telephone: 613-957-7285
• Email: meddevices-instrumentsmed@hc-sc.gc.ca

For more information about MDELs, contact the Medical Devices Establishment Licence Unit:

• Email: mdel.questions.leim@hc-sc.gc.ca

If you have a complaint about a medical device or other health product, you can report it by using the following online form:

• Health Product Complaint Form (FRM-0317)

For more information about medical device complaints, contact the Medical Devices Compliance Unit:

• Telephone: 613-954-6666
• Email: hc.mdcu-ucim.sc@canada.ca