Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41ka:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41KA (pt 2/3)
Character Range: 807522–811986

more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—the supply contravenes one or more of those prohibitions; or
                                                    (b) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—the supply contravenes one or more of those conditions
5.                                                  It is supplied while:                                                                                                                                                                                                                                                                             The person supplying the kind of medical device
                                                    (a) it is not included in the Register; and
                                                    (aa) it is not covered by an exemption in force under section 41GS; and
                                                    (b) it is not an exempt device; and
                                                    (c) there is not an approval under section 41HB relating to devices of that kind; and
                                                    (d) there is not an authority under section 41HC relating to devices of that kind; and
                                                    (e) there is not an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind.
5A.                                                 It is supplied while it is covered by an exemption in force under section 41GS, and the Secretary is satisfied that it is not fit to be used for its intended purpose                                                                                                                             The person supplying the kind of medical device
5B.                                                 It is supplied while it is included in the Register, but it appears to the Secretary that the quality, safety or performance of medical devices of that kind is unacceptable                                                                                                                      The person in relation to whom the kind of medical device is included in the Register
6.                                                  It has been suspended from the Register                                                                                                                                                                                                                                                           The person in relation to whom it was included in the Register
7.                                                  Its entry has been cancelled from the Register                                                                                                                                                                                                                                                    The person in relation to whom it was included in the Register
8.                                                  It is counterfeit goods (within the meaning of section 42E)                                                                                                                                                                                                                                       The person supplying the kind of medical device

 (2) The requirements may be one or more of the following:
 (a) to take specified steps, in the specified manner and within such reasonable period as is specified, to recall medical devices of that kind that have been distributed;
 (b) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, to the effect that the circumstances referred to in paragraph (1)(a) have occurred in relation to medical devices of that kind;
 (c) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:
 (i) medical devices of that kind;
 (ii) the circumstances referred to in paragraph (1)(a);
 (d) to publish, in the specified manner and within such reasonable period as is specified, specified information,