How To Import Medical Supplies Into Canada

Your how to guide on medical devices, bandages, masks, wheelchairs, ventilators and the like into Canada

If you are importing medical devices such as ventilators, bandages, face masks, wheelchairs, stethoscopes, hospital beds and the like into Canada, you must know what government parties are involved, what regulations must be followed, and the fundamental aspects of medical supply imports.

If you are importing medical devices due to the COVID-19 Global Pandemic, please review Health Canada’s notice on importing.

If you are importing medical supplies into the US, please visit How To Import Medical Supplies Into The US

Parties Involved:

Main Regulations:

  • All items imported into Canada must follow the guidelines of the Food And Drug Act and the Medical Devices Regulations.
  • Devices are grouped into four classes, from lowest risk (Class 1) to highest (Class 4). Refer to the Medical Devices Active License Listing database to find out into which class your imports fall.
  • There are certain labeling, marketing authorization requirements.
  • Commercial importers may be required to obtain a Establishment Licence, Site Licence or Establishment Registration; or authorization to conduct a clinical trial.
  • Importers must follow the Good Manufacturing Practices as defined in the Food and Drugs Act.
  • The Food and Drug Act considers a medical device to be: 
    “Any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in:

    (a) The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals;

    (b) Restoring, correcting or modifying a body function or the body structure of a human being or animals;

    (c) The diagnosis of pregnancy in human beings or animals; or

    (d) The care of human beings or animals during pregnancy and at and after birth of offspring, including care of the offspring, and includes a contraceptive device but does not include a drug.

Import Fundamentals:

  • You will be acting as the Importer of Record. Therefore, you are the party ultimately responsible for the accuracy and completeness of the import declaration; as well as, the payment of applicable duties and taxes into Canada.
  • Duty and tax must be paid upon importation into Canada.
  • The rate of duty is determined by the tariff of the commodity being imported, the value of the goods and, the origin of the goods.
  • Certain import documentation is required to be presented to the border services officer at the port of entry.
  • Your import may be subject to a customs review, inspection or audit prior to, or after the importation. Additional fees may be levied by the Government of Canada for these services.
  • You are required to keep your import records for six years following the date of import and can be audited by Customs at any point during this time.

FAQ: Medical Device Imports

What is/is not a Medical Device?

What is a Medical Device?
The term Medical Devices, 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.

Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, test kits for diagnosis, fat sculpting systems and contraceptive devices.

Words on the product or product marketing materials (websites etc) which state claims like "health care", "examination", "patient examination", "sterile" or "medical grade" indicate the product is a medical device.

What is not a Medical Device?
There are many products that have the same classification as medical devices but based on what industry they are manufactured and advertised for, they are not regulated.

Examples: Disposable gloves, plastic tubing, gauze. There are no requirements for Medical Devices imported for use in/on animals as the Medical Devices Regulations do not apply to these devices.

Are all medical supplies cleared under the same tariff?

No - Medical Devices fall under a range of tariff classifications depending on what the item is.

What are the labeling requirements for medical devices imported into Canada?
For some goods such as Investigational Testing devices to be used on human subjects and Special Access and Custom-made devices require special labeling.

Contact us for more information.
What is an Establishment License?

An Establishment License must be obtained in order to import and sell medical devices in Canada for human use. Such a license must be obtained by an Inspectorate through a Medical Device Establishment License Application.

Exemptions:

  • a retailer;
  • a healthcare facility;
  • a manufacturer of Class II, III or IV medical devices that only sells:
  1. medical devices for which they hold a valid licence, or
  2. medical devices subject to Parts 2 and 3 of the Medical Devices Regulations
  • a manufacturer of a Class I medical device that imports or distributes solely through a licenced establishment;
  • a person solely selling medical devices subject to Parts 2 and 3 of the Regulations; and
  • a dispenser.
What is a Medical Device License?

For medical devices with the class of II (2) through IV (4) require a Medical Devices License. Such a license can be obtained through the Medical Devices Bureau (MDB):

     Email: device_licensing@hc-sc.gc.ca
     Phone: 1.613.957.7285
     Fax: 1.613.957.6345

For more information on medical device license please visit Health Canada.

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