Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p14
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 14/43)
Character Range: 376259–379065

have been applied to the device:
(a) a Class IIa medical device (see Division 3.2, subparagraph 3.8(1)(b)(i));
(b) a Class I medical device that has a measuring function (see Division 3.2, paragraph 3.9(3)(a)).
 (2) The declaration must:
 (a) state that the declaration is a declaration of conformity made under clause 3.5 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and
 (b) state the name and business address of the manufacturer of the device; and
 (c) state the following information in relation to each device that has been verified:
 (i) the unique product identifier;
 (ii) the medical device classification;
 (iii) the device nomenclature system code; and
 (d) if the verification does not relate to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the verification relates (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:
 (i) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the approved type; and
 (ii) state that the kind of device conforms to the approved type; and
 (f) state that each kind of medical device or batch of devices complies with the applicable provisions of the essential principles and the classification rules;
 (g) state the basis on which the declaration is made; and
 (h) give details of any conformity assessment standard or medical device standard that has been applied to the kind of device or the processes used to manufacture the device; 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.

3.6  Records
 (1) The manufacturer of a kind of medical device that has been verified under this Part must keep the following records:
 (a) the documentation mentioned in subclause 3.4(3) of this Schedule;
 (b) for a Class III medical device or Class IIb medical device—the declaration of conformity under clause 3.5 of this Schedule;
 (c) any notice, report, certificate or other document in relation to the device, or a batch of devices that includes the device, issued to the manufacturer by the Secretary or an Australian conformity assessment body.
 (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the verification relates.
 (3) On request from the Secretary, the manufacturer must make the records available to the Secretary.

Part 4—Production quality