Medical Devices Regulations (SOR/98-282)

37. No person shall sell a medical device from a lot of licensed in vitro diagnostic devices in respect of which terms and conditions were set out in the licence pursuant to section 36, unless

• (a) the results and protocol of any test performed on the device in accordance with those terms and conditions have been provided to the Minister; and

• (b) the Minister determines, on the basis of the information received under paragraph (a), that the device continues to meet the safety and effectiveness requirements.

• 38. (1) The Minister may refuse to issue or amend a medical device licence if

  • (a) the applicant does not comply with these Regulations or any provisions of the Act relating to medical devices;

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

  • (c) the medical device does not comply with the labelling requirements set out in sections 21 to 23; or

  • (d) the applicant has not complied with a request for additional information or samples made pursuant to section 35 by the day specified in the request.

• (2) The Minister shall refuse to issue or amend a medical device licence if the medical device does not meet the safety and effectiveness requirements or if the information or samples provided pursuant to section 35 are insufficient to enable the Minister to determine whether the medical device meets those requirements.

• (3) If the Minister refuses to issue or amend a medical device licence, the Minister shall

  • (a) notify the applicant in writing of the reasons for the refusal; and

  • (b) give the applicant an opportunity to be heard.

39. If the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that a licensed medical device may not meet the safety and effectiveness requirements, the Minister may request the manufacturer to submit, on or before a specified day, information or samples to enable the Minister to determine whether the device meets those requirements.

• 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 for information or samples made pursuant to section 39 by the day specified in the request, or the information or samples provided are insufficient to enable the Minister to determine whether the medical device meets the safety and effectiveness requirements;

  • (e) the medical device no longer meets the safety and effectiveness requirements; 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.