Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41ka:p1
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41KA (pt 1/2)
Character Range: 112043–116293

41KA  Public notification and recovery 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 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 conformity assessment 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;
                                                    but 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;
                                                    but the conformity assessment procedures have not been applied to medical devices of that kind
5.                                                  It is supplied while:                                                                                                                                The person supplying the kind of medical device
                                                    (a) it is not included in the Register; 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.
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

 (2) The requirements may be one or both of the following:
 (a) to take specified steps, in the specified manner and within such reasonable period as is specified, to recover medical devices of that kind that have been distributed;
 (b) to inform the public or a specified class of persons, in the