Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41fn:p1
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41FN (pt 1/2)
Character Range: 71506–74222

41FN  Conditions applying automatically

Entry and inspection powers

 (1) The inclusion of a kind of medical device in the Register is subject to the conditions that the person in relation to whom the kind of device is included in the Register:
 (a) allow an authorised person:
 (i) to enter, at any reasonable time, any premises (including premises outside Australia) at which that person or any other person deals with medical devices of that kind; and
 (ii) while on those premises, to inspect those premises and medical devices of that kind at those premises and to take samples of medical devices of that kind; and
 (b) if requested to do so by an authorised person, produce to the person such documents relating to devices of that kind as the person requires and allow the person to copy the documents.

Delivery of samples

 (2) The inclusion of a kind of medical device in the Register is subject to a condition that the person in relation to whom the kind of device is included in the Register will deliver a reasonable number of samples of the kind of device if the Secretary so requests:
 (a) within the period specified in the request; and
 (b) in accordance with any other requirements specified in the request.
The period specified in the request must include at least 10 working days.

Availability etc. of information

 (3) The inclusion of a kind of medical device in the Register is subject to conditions that:
 (a) 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 compliance with the essential principles; or
 (ii) has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and
 (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
 (ii) has available information relating to changes to the kind of medical device, the product range, and quality management system, of the manufacturer of the device; or
 (iii) has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and
 (c)