Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies to an application for the issue of a conformity assessment certificate in respect of a kind of medical device if, in considering the application, the Secretary is required to examine the design of the device.
(2) The Secretary must make a decision on the application within 255 working days after the application is received at an office of the Department specified by the Secretary.
(3) For subregulation (2), a working day that occurs in any of the following periods is to be disregarded:
(a) if the Secretary sends a query, or a request for information, to the applicant or sponsor--the period beginning on the day when the query or request is sent and ending at the end of the day when the Secretary receives from the applicant or sponsor a response that enables the Secretary to proceed with the assessment;
(b) if an appeal is lodged in relation to the application--the period beginning on the day when the appeal is lodged and ending at the end of the day when the appeal is finally determined;
(c) any other period in relation to which the applicant or
sponsor agrees in writing for the purposes of this subregulation.