THERAPEUTIC GOODS ACT 1989 - SECT 41EJ Automatic conditions on conformity assessment certificates
THERAPEUTIC GOODS ACT 1989 - SECT 41EJ
Automatic conditions on conformity assessment certificates(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 any kind on those premises and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of medical devices of any kind on those premises or any thing on those premises that relates to medical devices of any kind; and
(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and
(b) if requested to do so by an authorised person:
(i) produce to the person such documents relating to devices of a kind covered by the certificate, or to the manufacturer's quality management system, as the person requires; and
(ii) allow the person to copy the documents.
(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.
(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.
(5A) A conformity assessment certificate is subject to any conditions prescribed by the regulations for the purposes of this subsection.
Conditions do not limit other conditions
(6) A condition imposed under this section is in addition to any
conditions imposed under this Division.