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;

• (c.1) a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that would adequately meet the requirements of the patient is not available for sale in Canada; and

• (d) the authorization is not being used by the manufacturer or importer to circumvent the requirements of Part 1 or 1.1.

(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.