Medical Devices Regulations (SOR/98-282)

49 (1) Subject to subsection (3), the Minister may suspend an establishment 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; or

• (c) failure to suspend the establishment licence would constitute a risk to the health or safety of patients, users or other persons.

(2) Before suspending an establishment 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 50, the Minister shall not suspend an establishment 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.