Commonwealth Consolidated Acts Commonwealth Consolidated ActsAn exemption under section 41GS is subject to conditions specified in the exemption about any of the following:
(a) the quantity of medical devices that are exempt;
(b) the source of those medical devices;
(c) the persons or class of persons who may import, manufacture, supply or export those medical devices;
(d) the supply of those medical devices (including the persons or class of persons to whom medical devices may be supplied for use and the circumstances under which a stockpile of medical devices may be supplied for use);
(e) the storage and security of those medical devices;
(ea) compliance with the requirements referred to in subsection 41CA(3) (about unique device identifiers of medical devices);
(f) the keeping and disclosure of, and access to, records about those medical devices;
(g) the disposal of those medical devices;
(h) the manner in which any of those medical devices are to be dealt with if a condition of the exemption is breached;
(i) any other matters that the Minister thinks appropriate.
Whether or not medical devices are exempt under section 41GS is not affected by whether or not there is a breach of a condition under this section in relation to those medical devices.
Note 1: There are offences and civil penalty provisions related to the breach of a condition of an exemption: see Division 3A of Part 4 - 11.
Note 2: Section 41GU deals with variation and revocation of the conditions.