Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p13
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 13/43)
Character Range: 373746–376512

to the design or production of such devices; and
 (c) to:
 (i) if the manufacturer arranged for examination and testing under clause 3.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A); or
 (ii) if the manufacturer arranged for examination and testing under clause 3.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A).
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.
 (2A) For the purposes of subparagraphs (2)(c)(i) and (ii), the information is the following:
 (a) information relating to:
 (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
 (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
  that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
 (3) Before manufacturing a medical device of a kind mentioned in subclause (1), the manufacturer must prepare documentation describing the manufacturing process to be used to produce the device.
 (4) Without limiting subclause (3), the documentation must include 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.

3.5  Declaration of conformity
 (1) The manufacturer of a Class III medical device or Class IIb medical device that has been verified under this Part 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)(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