Document ID: chunk:federal_register_of_legislation:C2023A00010:clause:12_26
Version: federal_register_of_legislation:C2023A00010
Segment Type: clause
Provision Reference: sch 12 cl 26
Character Range: 47731–48964

26  Paragraph 41FN(3)(b)
Repeal the paragraph, substitute:
 (b) at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:
 (i) has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or
 (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days; and
 (ba) at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:
 (i) has available information relating to changes to the kind of medical device, the product range or quality management system by the manufacturer of the kind of device; or
 (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days; and