Import Medical Devices

• Who is exempt from holding a Medical Device Establishment Licence (MDEL)?

The following are exempt from holding a Medical Device Establishment Licence (MDEL) under the Medical Devices Regulations to import into, or sell a medical device in Canada:

• any person who imports a medical device for his/her own personal use
• retailers, including:
  • companies that sell medical devices to the end-user (ultimate consumer or end user) for their own personal use; and
  • Canadian manufacturers of Class I medical devices who sell their devices solely to ultimate consumers or end users.
• healthcare facilities (as defined in section 1 of the Medical Devices Regulations) - 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.
• manufacturers of Class II, III or IV medical devices manufacturers of Class II, III or IV medical devices footnote * 1 that sell:
  • medical devices for which they hold a valid Medical Device Licence (MDL)
  • medical devices subject to parts 2 and 3 of the Medical Devices Regulations
  • * to be exempt, the manufacturer cannot import or sell medical devices manufactured by other companies.
• manufacturers of Class I medical devices manufacturers of Class II, III or IV medical devices footnote * 2 that import or distribute solely through a person that holds an establishment licence.
• * to be exempt, the manufacturer cannot import or sell medical devices manufactured by other companies.
• dispensers (as defined in section 1 of the Medical Devices Regulations) - means a person who is a member of a professional governing body and who is entitled, by virtue of their membership in that body, to manufacture or adapt a medical device in accordance with a health care professional's written directions in order to meet the specific requirements of a patient.
• anyone importing or selling devices only for use by animals (the label of the device must state that it is for use by animals).
• anyone importing or selling only medical devices subject to parts 2 and 3 of the Medical Devices Regulations, including:
  • custom-made devices;
  • for special access; and
  • medical devices for investigational testing involving human subjects (clinical trials).
• exporters of medical devices that are exempt under section 37 of the Food and Drugs Act:
  • Section 37 applies to medical devices that, although manufactured in Canada, are not intended to be sold for use in Canada.
  • Companies intending to invoke section 37 of the Food and Drugs Act related to medical devices must also meet the relevant requirements under the Medical Devices Regulations.
• warehouses that only store medical devices:
  • To be exempt, warehouses must not buy, sell or consign medical devices (see definition of warehouse in MDEL application GUI-0016, Appendix A - Glossary).