Medical Devices Regulations

40 (1) Subject to subsection (3), the Minister may suspend a medical device licence if the Minister has reasonable grounds to believe that

• (a) the licensee has contravened these Regulations or any provision of the Act relating to medical devices;

• (b) the licensee has made a false or misleading statement in the application;

• (c) the licensee has failed to comply with the terms and conditions of the licence;

• (d) the licensee has not complied with a request made under section 39 on or before the day specified in the request;

• (d.1) the samples — or the analysis or other information — submitted by the licensee in response to a request made under section 39 are insufficient to enable the Minister to determine whether the medical device meets the applicable requirements of sections 10 to 20;

• (e) the medical device no longer meets the applicable requirements of sections 10 to 20; or

• (f) on the basis of information obtained after the device was licensed, the quality management system under which the device has been designed, in the case of a Class III or IV device, or manufactured, assembled, processed, packaged, refurbished or modified, in the case of a Class II, III or IV device, is inadequate to ensure that the device meets its specifications.

(2) Before suspending a medical device licence, the Minister shall consider

• (a) the licensee’s history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and

• (b) the risk that allowing the licence to continue to be in force would constitute for the health or safety of patients, users or other persons.

(3) Subject to section 41, the Minister shall not suspend a medical device licence until

• (a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

• (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

• (c) the licensee has been given an opportunity to be heard in respect of the suspension.