Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p24
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 24/43)
Character Range: 401822–404587

of a medical device if:
 (a) the manufacturer has implemented, and had assessed under clause 5.3 of this Schedule, a quality management system that is to be applied to the device; and
 (b) after assessment, the manufacturer plans to make:
 (i) a substantial change to the system; or
 (ii) a change to the kinds of medical devices to which the system is to be applied.
 (2) The manufacturer must:
 (a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
 (b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 5.4 of this Schedule.
 (3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 5.3(2) of this Schedule in relation to the system or kinds of devices.
 (4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 5.4 of this Schedule.

5.6  Information to be given to authorised person
 (1) If requested to do so by an authorised person, the manufacturer of a medical device must:
 (a) give to the Secretary any of 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 5.4(5) of this Schedule;
 (ii) the quality records in relation to the final inspection and testing of the kinds of medical device to which the system is applied (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 management system is operating effectively.
 (2) If any inspections or tests are carried out by an authorised person in relation to the manufacturer's premises, or medical devices manufactured by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.

5.7  Declaration of conformity
 (1) The manufacturer of a Class IIb medical device to which a quality management system that has been assessed under clause 5.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device.
Note: This clause need not be applied to the following kinds of medical devices if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device:
(a) a Class