Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p6
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 6/43)
Character Range: 355767–358592

of the essential principles, the manufacturer of the device must arrange for examination by the Secretary or an Australian conformity assessment body of the design of the kind of device.
 (3) For the purpose of enabling the examination to be carried out, the manufacturer must have available:
 (a) information, in writing, in relation to the following matters in relation to the kind of medical device:
 (i) the design;
 (ii) the production process;
 (iii) the intended performance; and
 (b) a copy of the documentation mentioned in paragraph 1.4(5)(c) of this Schedule necessary to assess whether the kind of medical device complies with the applicable provisions of the essential principles.
 (4) If, after examination by the Secretary or an Australian conformity assessment body of the design of a kind of medical device, the manufacturer makes a substantial change to the design, or the intended performance, of the kind of device, the manufacturer must:
 (a) notify the Secretary or an Australian conformity assessment body, in writing, of the change; and
 (b) arrange for examination of the change by the Secretary or the Australian conformity assessment body to assess whether the design, or the intended performance, of the medical device, as changed, complies with the applicable provisions of the essential principles.
 (5) For the purpose of enabling an examination to be carried out under subclause (4), the manufacturer must have available, in writing, details of any consequential changes to the documentation in relation to the design of the device mentioned in paragraph 1.4(5)(c) of this Schedule.
Note: This clause need not be applied to:
(a) a Class IIb medical device—see Division 3.2, paragraphs 3.7(1)(a) and (2)(a); or
(b) a Class 3 IVD medical device—see Division 3.2, paragraph 3.7A(a); or
(c) a Class IIa medical device—see Division 3.2, paragraphs 3.8(1)(a) and (2)(a); or
(d) a Class 2 IVD medical device—see Division 3.2, paragraph 3.8A(a).

1.7  Information to be given to authorised person
 (1) If requested to do so by an authorised person, the manufacturer of a kind of medical device must:
 (a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device to which the system is applied:
 (i) a copy of the documentation mentioned in subclause 1.4(5) of this Schedule;
 (ii) data in relation to the design of the kinds of medical device (for example, the results of any analysis of the device, calculations, tests);
 (iii) data in relation to the manufacture of the kinds of medical device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
 (b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality