Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41ewa:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41EWA (pt 1/2)
Character Range: 693993–696982

41EWA  Conformity assessment body determinations
 (1) The regulations may make provision for and in relation to empowering the Secretary to make conformity assessment body determinations.
 (2) A conformity assessment body determination is a determination that a specified Australian corporation is an Australian conformity assessment body for the purposes of this Act.
 (3) The regulations may make provision for and in relation to the following matters:
 (a) applications for conformity assessment body determinations;
 (b) the approval by the Secretary of a form for such an application;
 (c) information that must accompany such an application;
 (d) the application fee for such an application;
 (e) the lapsing of such an application;
 (f) the assessment by the Secretary of whether a conformity assessment body determination should be made in response to such an application;
 (g) the assessment fee for such an assessment;
 (h) the duration of conformity assessment body determinations.
 (4) A conformity assessment body determination:
 (a) may be of general application; or
 (b) may be limited to either or both of the following:
 (i) one or more specified medical devices;
 (ii) one or more specified conformity assessment procedures.
 (4A) If under the regulations the Secretary makes a conformity assessment body determination, the Secretary must assign a unique identification number to the body.
 (4B) The Secretary must publish a list of the Australian conformity assessment bodies on the Department's website.
 (4C) The Secretary may also publish on the Department's website any information relating to Australian conformity assessment bodies and either to conformity assessment body determinations or to certification‑related activities of Australian conformity assessment bodies.
 (5) The regulations may provide that a conformity assessment body determination is subject to:
 (a) the conditions prescribed by the regulations; and
 (b) such other conditions (if any) as are specified in the determination.
Note: See subsections 41MN(10) to (12) and 41MNA(3) for offences and a civil penalty for a breach of the conditions.
 (6) The following are examples of conditions that may be prescribed:
 (a) a condition that the body will allow an authorised person:
 (i) to enter, at any reasonable time, premises used by the body to carry on certification‑related activities; and
 (ii) while on those premises, to inspect those premises and anything on those premises that concerns certification‑related activities carried on by the body; and
 (iii) while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns certification‑related activities carried on by the body; and
 (iv) while on those premises, to inspect, and make copies of, any documents that concern certification‑related activities carried on by the body;
 (b) a condition that the body will, if requested to do so by the Secretary, give the