Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p29
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 29/43)
Character Range: 414516–417354

(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 device that the manufacturer intends to be supplied in a sterile state—state that the production quality assurance procedures have also been applied to the device; and
 (e) if the technical documentation applies to a Class IIa medical device that the manufacturer intends to be supplied in a non‑sterile state, or a Class I medical device that has a measuring function and that the manufacturer intends to be supplied in a non‑sterile state—state which of the following conformity assessment procedures have also been applied to the device:
 (i) the verification procedures;
 (ii) the production quality assurance procedures;
 (iii) the product quality management system procedures; and
 (f) if the technical documentation does not apply to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the technical documentation applies (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and
 (g) state that each kind of medical device to which the technical documentation applies complies with the applicable provisions of the essential principles, the classification rules, and these procedures; and
 (h) if the technical documentation applies to any of the following kinds of medical devices:
 (i) a Class IIa medical device;
 (ii) a Class 2 IVD medical device;
 (iii) a Class I medical device that the manufacturer intends to be supplied in a sterile state;
 (iv) a Class I medical device that has a measuring function;
  state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the kind of medical device, or the quality management system that has been applied to the kind of device, as a result of the application to the device of the conformity assessment procedures set out in Part 3, 4 or 5 of this Schedule; and
 (i) give details of any medical device standard or conformity assessment standard that has been applied to the device; and
 (j) be signed by a person authorised by the manufacturer; and
 (k) set out the name and position of the person signing the declaration; and
 (l) state the date when the declaration is signed.

6.7  Records
 (1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must keep the following records:
 (a) the technical documentation prepared under clause 6.4 of this Schedule, including any revisions of the documentation prepared as