Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p11
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 11/43)
Character Range: 368571–371408

system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.

3.2  References to kinds of medical devices
  A reference in this Part to a kind of medical device includes a reference to an individual medical device.

3.3  Verification of conformity
 (1) The manufacturer of a medical device must arrange for examination and testing by the Secretary or an Australian conformity assessment body of each device of that kind, or a representative sample from a batch of medical devices of that kind, to verify that:
 (a) for a kind of device in relation to which the type examination procedures have been applied—each device, or representative sample, conforms to the approved type; and
 (b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—each device, or representative sample, is in accordance with the technical documentation prepared under clause 6.4 of those procedures for that kind of device; and
 (c) each device, or representative sample, complies with the applicable provisions of the essential principles, the classification rules and these conformity assessment procedures.
 (2) For the purpose of enabling the examination and testing to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
 (a) the name and business address of the manufacturer;
 (b) the documentation describing the manufacturing process to be used to manufacture the kind of device;
 (c) a description of the procedures that have been, or will be, implemented to ensure that all devices of that kind manufactured by the manufacturer will be uniform;
 (d) an undertaking to implement those procedures to ensure that all devices of that kind manufactured by the manufacturer will be uniform;
 (e) an undertaking by the manufacturer:
 (i) if the manufacturer arranged for examination and testing by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or
 (ii) if the manufacturer arranged for examination and testing by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device;
 (f) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and a copy of the technical documentation required under