Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p25
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 25/43)
Character Range: 404347–407107

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)(iii));
(b) a Class I medical device that has a measuring function (see Division 3.2, paragraph 3.9(3)(c)).
 (2) The declaration must:
 (a) state that the declaration is a declaration of conformity made under clause 5.7 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 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) for a kind of device in relation to which the type examination procedures have been applied—state that:
 (i) the type examination procedures have been applied to the kind of device; and
 (ii) the kind of device conforms to the approved type; and
 (f) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—state that the kind of device is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the kind of device; and
 (g) 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
 (h) give details of any conformity assessment standard that has been applied to the system; and
 (i) be signed by a person authorised by the manufacturer; and
 (j) set out the name and position of the person signing the declaration; and
 (k) state the date when the declaration is signed.

5.8  Records
 (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 5.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device:
 (a) the documentation mentioned in subclause 5.4(5) of this Schedule;
 (b) details of any changes made to the system and to the information and documentation required under