Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41ka:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41KA (pt 1/3)
Character Range: 803157–807809

41KA  Public notification, and recall, of medical devices
 (1) The Secretary may, in writing, impose requirements, relating to a kind of medical device, on a person if:
 (a) any of the circumstances referred to in the second column of an item in the following table occur in relation to the kind of device; and
 (b) the person is referred to in the third column of that item of the table.

Circumstances in which requirements may be imposed
Item                                                Circumstance relating to a kind of medical device                                                                                                                                                                                                                                                 Person subject to requirements
1.                                                  It is supplied while it is included in the Register, but the Secretary is satisfied that medical devices of that kind do not comply with the essential principles                                                                                                                                 The person in relation to whom it is included in the Register
2.                                                  It is supplied while it is included in the Register, but the Secretary is satisfied that the conformity assessment procedures have not been applied to medical devices of that kind and that requirements, comparable to those procedures, have not been applied to medical devices of that kind  The person in relation to whom it is included in the Register
3.                                                  It is supplied while:                                                                                                                                                                                                                                                                             The person supplying the kind of medical device
                                                    (a) medical devices of that kind are exempt devices; or
                                                    (b) there is an approval under section 41HB relating to devices of that kind; or
                                                    (c) there is an authority under section 41HC relating to devices of that kind; or
                                                    (d) there is an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind;
                                                    but the Secretary is satisfied that medical devices of that kind do not comply with the essential principles
4.                                                  It is supplied while:                                                                                                                                                                                                                                                                             The person supplying the kind of medical device
                                                    (a) medical devices of that kind are exempt devices; or
                                                    (b) there is an approval under section 41HB relating to devices of that kind; or
                                                    (c) there is an authority under section 41HC relating to devices of that kind; or
                                                    (d) there is an approval under subsection 41HD(1), (1A) or (2) relating to devices of that kind;
                                                    but the Secretary is satisfied that the conformity assessment procedures have not been applied to medical devices of that kind and that requirements, comparable to those procedures, have not been applied to medical devices of that kind
4A.                                                 It is supplied and the Secretary is satisfied that:                                                                                                                                                                                                                                               The person supplying the kind of medical device
                                                    (a) if there are one or 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)