Medical Devices Regulations

68.16 The Minister may refuse to issue or amend an authorization for a medical device if

• (a) the Minister has reasonable grounds to believe that the manufacturer has contravened these Regulations or any provision of the Act relating to medical devices;

• (b) the Minister has reasonable grounds to believe that the device is not labelled in accordance with sections 21 and 23; or

• (c) the manufacturer has not submitted to the Minister all information, documents or material that was requested under section 68.23 to enable the Minister to determine whether to issue or amend the authorization, within the time limit specified in the request.