Medical Devices Regulations

68.38 (1) The Minister may request from the holder of a medical device licence, in respect of the medical device that is set out in column 2 of the List of Medical Devices for Expanded Use for which the licence was issued, any information in relation to the expanded use that is set out in column 3 of that list that the holder possesses or to which they have reasonable access.

(2) The Minister may request from the holder of an authorization, in respect of the Class II, III or IV medical device set out in column 2 of the List of Medical Devices for Expanded Use for which the authorization was issued, any information in relation to the expanded use set out in column 3 of that list that the holder possesses or to which they have reasonable access.

(3) The holder of the licence or authorization shall submit to the Minister the information that the Minister requests within the time limit specified in the request.