Commonwealth Consolidated Acts

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Conditions of exemptions

                   An 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.

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