Medical Devices Regulations

71 (1) If a health care professional wishes to obtain a medical device referred to in section 70, the professional shall apply to the Minister for an authorization that would permit the manufacturer or importer of the device to sell, or to import and sell, the device to that professional.

(2) The application shall contain the following:

• (a) the name of the device, its class and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

• (b) the number of units required;

• (c) the name and address of the manufacturer or importer;

• (d) the name, title and telephone number of the representative of the manufacturer or importer to contact for any information concerning the device;

• (e) the diagnosis, treatment or prevention for which the device is required;

• (f) a statement that sets out

  • (i) the reasons the device was chosen for the diagnosis, treatment or prevention,

  • (ii) the risks and benefits that are associated with its use, and

  • (iii) the reasons the diagnosis, treatment or prevention could not be accomplished using

    • (A) a licensed medical device that is available for sale in Canada, or

    • (B) a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that is available for sale in Canada;

• (g) the name and address of each health care facility at which the device is to be used by that professional;

• (h) the known safety and effectiveness information in respect of the device;

• (i) a written undertaking by the health care professional that the professional will inform the patient for whom the device is intended of the risks and benefits associated with its use;

• (j) the directions for use, unless directions are not required for the device to be used safely and effectively; and

• (k) in the case of a custom-made device, a copy of the health care professional’s written direction to the manufacturer giving the design characteristics of the device.