Medical Devices Regulations

72 (1) The Minister shall issue an authorization referred to in subsection 71(1) to a manufacturer or importer if the Minister determines that

• (a) the benefits that may be obtained by the patient through the use of the device outweigh the risks associated with its use;

• (b) the health or safety of patients, users or other persons will not be unduly affected;

• (c) a licensed device that would adequately meet the requirements of the patient is not available in Canada; and

• (d) the authorization is not being used by the manufacturer or importer to circumvent the requirements of Part 1.

(2) The authorization issued under subsection (1) shall specify

• (a) the number of units of the device authorized to be imported;

• (b) the number of units of the device authorized to be sold; and

• (c) the name of the health care professional to whom the manufacturer or importer may sell the device.