Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p39
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 39/43)
Character Range: 440142–442920

the device, or to a serious deterioration in his or her state of health; or
 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in paragraph (a) that has led the manufacturer to take steps to recall a device that has been distributed.
Note: Clauses 7.3 and 7.4 are intentionally not used.

7.5  System or procedure packs
 (1) The manufacturer of a system or procedure pack must make a declaration of conformity in relation to the system or procedure pack.
 (2) The declaration must:
 (a) state that the declaration is a declaration of conformity made under clause 7.5 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
 (b) state the name and business address of the manufacturer of the system or procedure pack; and
 (c) state sufficient information to enable the user to identify the system or procedure pack or the contents of the system or procedure pack; and
 (d) identify each item in the system or procedure pack; and
 (e) except in relation to a medical device covered by paragraph (ia)—state that the manufacturer has:
 (i) a conformity assessment document, a declaration of conformity under clause 6.6 or a statement under subclause 7.2(2) for each medical device in the system or procedure pack for which such a document, declaration or statement is required; and
 (ii) evidence that each medical device in the system or procedure pack complies with the applicable provisions of the essential principles; and
 (f) state the registration or listing number for each medicine or other therapeutic goods, or the biological number for each biological, in the system or procedure pack; and
 (g) state that each medical device in the system or procedure pack is intended to be used for its original intended purpose, and each medicine, biological or other therapeutic goods in the system or procedure pack is intended to be used within the approved indications of the medicine, biological or other therapeutic goods; and
 (h) state that the mutual compatibility of each medical device, medicine, biological or other therapeutic goods, and any other goods, in the system or procedure pack has been verified in accordance with:
 (i) the instructions for use of each medical device included in the system or procedure pack, being the instructions for use provided by the manufacturer of the device; and
 (ii) the approved indications of each medicine, biological and other therapeutic goods (if any) included in the system or procedure pack; and
 (ha) state that the manufacturer of the system or procedure pack has manufactured the system or procedure pack in accordance with the instructions referred to in subparagraph (h)(i) and the indications referred to in subparagraph (h)(ii);