Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p7
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 7/43)
Character Range: 358330–361113

kinds of medical device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
 (b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
 (2) If any inspections or tests are carried out by an authorised person in relation to the manufacturer's premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.

1.8  Declaration of conformity
 (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3 of this Schedule has been applied 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 1.8 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 system has been applied:
 (i) the unique product identifier;
 (ii) the medical device classification;
 (iii) the device nomenclature system code; and
 (d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the system has been applied (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
 (e) state that each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules, and the full quality assurance procedures, at each stage, from the design of the device until its final inspection before being supplied; and
 (f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and
 (g) give details of any conformity assessment standard or medical device standard that has been applied to a kind of device to which the system has been applied; and
 (h) be signed by a person authorised by the manufacturer; and
 (i) set out the name and position of the person signing the declaration; and
 (j) state the date when the declaration is signed.

1.9  Records
 (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3