Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p17
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 17/43)
Character Range: 383891–386771

is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or
 (ii) if the manufacturer arranged for assessment of the system under clause 4.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming 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 production of the medical devices produced 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 inspection and quality assurance techniques applied in the manufacturing process, including, in particular, information about the following:
 (i) the processes and procedures to be used (particularly in relation to sterilisation) and the documents relating to those procedures;
 (ii) the procedures to be used for purchasing goods or services in relation to the production of the kind of device produced and the documents relating to those procedures;
 (iii) product identification procedures