Medical Devices Regulations

68.32 (1) The Minister may, for the purposes of determining whether there is sufficient evidence to support the conclusion that the benefits associated with a medical device outweigh the risks, request that the holder of an authorization for 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.