Medical Devices Regulations

25 (1) If the Minister believes on reasonable grounds, after reviewing a report or information brought to his or her attention, that a Class I medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, an analysis or other information to enable him or her to determine whether the device meets those requirements.

(2) The Minister may direct the manufacturer to stop the sale of the medical device if

• (a) the manufacturer has not complied with the request on or before the day specified in the request; or

• (b) the Minister determines, on the basis of the information submitted, that the device does not meet the applicable requirements of sections 10 to 20.

(3) The Minister shall lift the direction to stop the sale if

• (a) the Minister determines, on the basis of the information submitted, that the medical device meets the applicable requirements of sections 10 to 20;

• (b) corrective action has been taken to ensure that the medical device meets the applicable requirements of sections 10 to 20; or

• (c) the Minister’s determination was unfounded.