Document ID: chunk:federal_register_of_legislation:C2010A00141:clause:2_1c
Version: federal_register_of_legislation:C2010A00141
Segment Type: clause
Provision Reference: sch 2 cl 1C
Character Range: 20529–21760

1C  Before subsection 9D(4)
Insert:
 (3C) If:
 (a) the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and
 (b) the only effect of the variation would be:
 (i) to reduce the class of persons for whom the kind of medical device is suitable; or
 (ii) to add a warning, restriction or precaution, that does not include any comparison of the kind of medical device with any other therapeutic goods by reference to quality, safety or performance;
the Secretary must vary the entry in accordance with the request.
 (3D) If:
 (a) the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and
 (b) subsection (3C) does not apply to the request; and
 (c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or performance of the kind of medical device for the purposes for which it is to be used;
the Secretary may vary the entry in accordance with the request.