Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41ej
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41EJ
Character Range: 48129–50772

41EJ  Automatic conditions on conformity assessment certificates

Entry and inspection powers

 (1) A conformity assessment certificate is subject to the conditions that the manufacturer in respect of whom the certificate is issued will:
 (a) allow an authorised person:
 (i) to enter, at any reasonable time, premises (including premises outside Australia) at which the person or any other person deals with medical devices of a kind covered by the certificate; and
 (ii) while on those premises, to inspect those premises and medical devices of that kind at those premises and to take samples of devices of that kind; and
 (iii) to carry out tests, or require tests to be carried out, on the premises on medical devices of a kind covered by the certificate; and
 (b) if requested to do so by an authorised person:
 (i) produce to the person such documents relating to devices of that kind, or to the manufacturer's quality management system, as the person requires; and
 (ii) allow the person to copy the documents.

Review

 (2) A conformity assessment certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will cooperate in any review by the Secretary of the certificate to determine whether the conformity assessment procedures relating to the following matters have been applied to the kinds of medical devices covered by the certificate:
 (a) the application of quality management systems for the manufacture of medical devices;
 (b) the certification of compliance with the essential principles;
 (c) any other requirement of the conformity assessment procedures specified in the regulations made for the purposes of subsection 41EC(2).

Notification of substantial changes

 (3) A conformity assessment certificate is subject to the condition that the person in respect of whom the certificate is issued will notify the Secretary, in writing, of any plan for substantial changes to:
 (a) quality management systems; or
 (b) the product range covered by those systems; or
 (c) the product design of kinds of medical devices;
in respect of which the certificate is issued.

Fees

 (4) A conformity assessment certificate is subject to the condition that the applicant for the certificate will pay a fee, prescribed in the regulations, for a review under subsection (2), when the fee becomes due and payable.

 (5) The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices.

Conditions do not limit other conditions

 (6) A condition imposed under this section is in addition to any conditions imposed under this Division.