Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41ja
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41JA
Character Range: 100644–102339

41JA  Secretary may require information

 (1) The Secretary may, by written notice given to a person:
 (a) who is an applicant for a conformity assessment certificate that would relate to a kind of medical device; or
 (b) who holds a conformity assessment certificate that relates to a kind of medical device; or
 (c) who is an applicant for the inclusion of a kind of medical device in the Register; or
 (d) in relation to whom a kind of medical device is, or was at any time during the notice period under subsection (2), included in the Register;
require the person to give to the Secretary information or documents, relating to devices of that kind, that are relevant to one or more of the following:
 (e) whether the devices comply with the essential principles;
 (f) whether the conformity assessment procedures have been applied to the devices;
 (g) whether the devices comply with conditions (if any) imposed on a conformity assessment certificate issued in respect of the device or the inclusion of the device in the Register;
 (h) whether the devices comply with every requirement (if any) relating to advertising applicable under the regulations;
 (i) if the kind of medical device is included in the Register in relation to the person—whether medical devices of that kind are being:
 (i) supplied in Australia; or
 (ii) imported into Australia; or
 (iii) exported from Australia;
 (j) any other matter prescribed by the regulations for the purposes of this paragraph.

 (2) For the purposes of paragraph (1)(d), the notice period is the period:
 (a) of the length specified in the regulations; and
 (b) ending on the day before the Secretary gives the notice under subsection (1).