Medical Devices Regulations

36 (1) If the Minister determines that a medical device in respect of which an application is submitted meets the safety and effectiveness requirements, the Minister shall

• (a) issue to the manufacturer of the device a medical device licence, in the case of an application for a medical device licence; or

• (b) amend the medical device licence, in the case of an application for a medical device licence amendment.

(2) The Minister may set out in a medical device licence terms and conditions respecting

• (a) the tests to be performed on a device to ensure that it continues to meet the safety and effectiveness requirements; and

• (b) the requirement to submit the results and protocols of any tests performed.

(3) The Minister may amend the terms and conditions of the medical device licence to take into account any new development with respect to the device.

(4) The holder of the medical device licence shall comply with the terms and conditions of the licence.