Medical Devices Regulations

61.5 (1) The Minister may, for the purposes of determining whether a medical device meets the applicable requirements of sections 10 to 20, request that the holder of a medical device licence issued in respect of the device submit, within a specified time limit, any of the following:

• (a) summary reports; or

• (b) information on the basis of which summary reports were prepared.

(2) The holder shall submit to the Minister the summary reports or information, or both, that the Minister requests within the time limit specified in the request.