Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p23
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 23/43)
Character Range: 399210–402060

aware of information referred to in subclause (3A).
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
 (3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:
 (a) information relating to:
 (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
 (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
  that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
 (4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records).
 (5) The documentation of the system must include adequate information in relation to the following matters:
 (a) the manufacturer's quality objectives;
 (b) the organisation of the manufacturer's business, including, in particular, a description of the following:
 (i) the organisational structure of the business;
 (ii) the responsibilities of managerial staff and their authority in relation to the quality of the medical devices manufactured by the manufacturer;
 (iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of product is being achieved and how products that fail to meet the desired quality are controlled;
 (c) the examinations and tests to be carried out after manufacture, including, in particular, information about:
 (i) the frequency with which the examinations and tests are to be carried out; and
 (ii) the equipment (including the traceability of the calibration of the equipment) to be used to carry out the examinations and tests;
 (d) the quality records to be kept, including, for example, records in relation to inspections, tests, calibration of equipment and qualifications of staff.

5.5  Changes to product quality management system or kinds of medical device
 (1) This clause applies to the manufacturer 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: