Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p19
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 19/43)
Character Range: 389066–391847

authorised person
 (1) If requested to do so by an authorised person, the manufacturer of a medical device must:
 (a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device to which the system is applied:
 (i) a copy of the documentation mentioned in subclause 4.4(5) of this Schedule;
 (ii) data in relation to the production of the 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 under this clause, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests.

4.7  Declaration of conformity
 (1) The manufacturer of a Class 4 IVD medical device, Class 3 IVD medical device, Class III medical device or Class IIb medical device to which a quality management system that has been assessed under clause 4.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device.
Note: This clause need not be applied to the following kinds of medical devices, if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device:
(a) a Class IIa medical device—see Division 3.2, subparagraph 3.8(1)(b)(ii);
(b) a Class 2 IVD medical device—see Division 3.2, paragraph 3.8A(b);
(c) a Class I medical device that the manufacturer intends to be supplied in a sterile state—see Division 3.2, subclause 3.9(2);
(d) a Class I medical device that has a measuring function—see Division 3.2, paragraph 3.9(3)(b).
 (2) The declaration must:
 (a) state that the declaration is a declaration of conformity made under clause 4.7 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 medical device classification;
 (ii) 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) for a kind of device in relation to which the type examination procedures have been applied—state that:
 (i)