Parties Involved:

• Canada Border Services Agency (CBSA)
• Health Canada
• Customs Broker
• Carrier

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.
  

Masks And Other Medical Supplies:

• Disposable face masks, medical gowns and face shields for use in preventing the transmission of infection are usually considered Class I medical devices. However 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. If they do not make the above medical claims they are not medical devices.
• Class I devices are not required to be licensed, however a Medical Devices Establishment License (MDEL) OR authorization from Health Canada under the COVID-19 Interim Order is required to import these devices, unless the Importer is also one of the following exempted parties:
  
  1) A Retailer;
  2) A Health Care Facility;
  3) Manufacturers of Class I devices if the manufacturer imports or distributes through a person who holds an Establishment License;
  4) A person who only imports a medical device for their own personal use ("ultimate consumer")
  5) Establishments only importing or selling veterinary products;
  6) Dispensers; and
  7) Establishments that only import or sell custom-made devices, medical devices for Special Access, or devices for Investigational Testing involving human subjects.
• Health Canada's guidance document on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016), defines Retailers, Health Care Facilities and Ultimate Consumers as:
  
  "Retailers are persons who sell a device, or a service utilizing a device, solely to the ultimate consumer/end user. Note: Many retailers may not be aware whether devices are being purchased by ultimate consumers for their own use. However, where a sale occurs to those who are identifiable as not being the ultimate consumers, the seller is considered to be a distributor, not a retailer." (A Distributor of medical devices does require a MDEL)
  
• Health Care Facility "means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities."
• Ultimate consumer "is the individual who purchases or receives a medical device for their own personal use (including use within their household) or receives treatment or diagnosis with a medical device from a healthcare facility or provider. Businesses that purchase medical devices solely for use by their employees during work activities (e.g. first aid kits, disposable gloves) or for incidental emergency use are also considered ultimate consumers as long as they are not in the business of offering healthcare services to employees or other individuals."
• If you are unsure if you qualify for these exemptions, please contact Health Canada’s Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca.
  
• If you require a Medical Device Establishment license or wish to apply for authorization to import under the interim order, information is found in our article “Getting COVID19 Medical Supplies Into Canada” and on the Health Canada site “Optimizing the use of masks and respirators during the COVID-19 outbreak“
• Should you require assistance with a Medical Device Establishment license, please contact us to request our trade consulting services.
• Note: Although Class I devices are exempt from the device licensing requirements of Sections 26 to 43 of the Medical Devices Regulations, it is the manufacturer's responsibility to ensure that Class I devices imported for sale or sold in Canada comply with the remaining sections of the Medical Devices Regulations.
• Face masks and other personal protective equipment that make no medical claims and are not for use in a healthcare setting are not regulated by Health Canada. We recommend that the customs documents clearly indicate the masks are not for medical use and the product itself be marked with a notation such as “Not for Medical Use” or “For Industrial Use”.
• Medical claims are words and statements such as "health care", "examination", "patient examination", "sterile" or "medical grade" or contain images or symbols that signify a medical use such as care, body, safe, guard, or cross should not be on the packaging.

HS Tariff Classification And Duty Rates:

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.