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THERAPEUTIC GOODS ACT 1989 - SECT 41GT Conditions of exemptions

THERAPEUTIC GOODS ACT 1989 - SECT 41GT

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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