Medical Devices Regulations

25 (1) If the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that a Class I 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 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 a Class I medical device if

• (a) the manufacturer does not comply with a request made pursuant to subsection (1) by the day specified in the request; or

• (b) the Minister determines, on the basis of the information submitted pursuant to subsection (1), that the device does not meet the safety and effectiveness requirements.

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

• (a) the manufacturer provides the information requested;

• (b) corrective action has been taken to ensure that the medical device satisfies the safety and effectiveness requirements; or

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