Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p28
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 28/43)
Character Range: 411997–414762

documentation to take account of the change.

6.5  Post‑marketing system
 (1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must establish, and keep up‑to‑date, a post‑marketing system that complies with subclause (2) for use in relation to devices of that kind.
 (2) A post‑marketing system complies with this subclause in relation to a medical device if the system requires the manufacturer of the device:
 (a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and
 (b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and
 (c) to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of:
 (i) information relating to:
 (A) any malfunction or deterioration in the characteristics or performance of the kind of device; or
 (B) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
 (C) 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; or
 (ii) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
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.

6.6  Declaration of conformity
 (1) The manufacturer of a kind of medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must make a declaration of conformity in relation to the kind of device.
 (2) The declaration must:
 (a) state that the declaration is a declaration of conformity made under clause 6.6 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
 (b) state the name and business address of the manufacturer of the device; and
 (c) state the following information in relation to each kind of medical device to which the technical documentation applies:
 (i) the unique product identifier;
 (ii) the medical device classification;
 (iii) the device nomenclature system code; and
 (d) if the technical documentation applies to a Class IIa medical device that the manufacturer intends to be supplied in a sterile state or a Class I medical