top of page
  • Can anybody import and sell a Class II, III or IV Medical Device in Canada?
    Only Licensed Health Canada Medical Device Establishments can import or distribute Class II & III and IV Medical Devices. You can authenticate your distributor through this link; http://webprod5.hc-sc.gc.ca/el-le/prepare-search-recherche-mdel-lepim.do?lang=eng
  • What Laws govern Class II, III or IV Medical Devices in Canada?
    It is Canadian Law not “just a safety organization” http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-5.html#h-11
  • If a Class II, III or IV Medical device has CSA Approval but does not have Health Canada Approval, is it legal to be in Canada?
    No, CSA is an electrical safety approval only and has nothing to do with Health Canada Medical Device Licence approvals.
  • What type of Class II, III & IV Aesthetic Medical Device be legally used on humans in Canada?
    Only Health Canada Approved Class II, III, IV Medical Devices can be used on humans in Canada.
  • Can any Class II, III & IV Aesthetic Medical Device be legally imported into Canada?
    No, Only Health Canada Approved Class II, III, IV Medical Devices can ONLY be Imported into Canada and ONLY by a Licenced Health Canada Medical Device Establishment.
  • What type of Class II, III & IV Aesthetic Medical Devices, can be legally sold, advertised or offered for sale in Canada?
    Only Health Canada Approved Class II, III, IV Medical Devices can be offered, advertised for sale, or sold into Canada.
  • How do I know if a Class II, III or IV Medical Devices has a Health Canada Licence?
    Search Engine such as link below will provide the answer…if a number is not found then the device is considered an illegal medical device in Canada http://webprod5.hc-sc.gc.ca/mdll-limh/prepareSearch-preparerRecherche.do?type=active&lang=eng
  • What common Aesthetic Medical Devices are considered Class II, III or IV Medical Devices in Canada?
    IPL, Laser and RF devices are all Class II & III and must have a valid Health Canada Medical Device Licence Number.
bottom of page