Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41ja:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41JA (pt 1/3)
Character Range: 779804–782562

41JA  Secretary may require information or documents
 (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, or an Australian conformity assessment body certificate, that relates to a kind of medical device; or
 (ba) who held, at any time during the notice period under subsection (2), a conformity assessment certificate, or an Australian conformity assessment body certificate, that related 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 included in the Register; or
 (da) in relation to whom a kind of medical device 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 or whether requirements, comparable to those 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 either of the following has not been complied with in relation to the devices:
 (i) an applicable provision of the Therapeutic Goods Advertising Code;
 (ii) any other requirement relating to advertising applicable under Part 5‑1 or 5‑1A or 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;
 (iaa) if the kind of medical device is included in the Register in relation to the person and there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—whether any supplies in Australia, any imports into Australia, any exports from Australia or any manufacture in Australia of medical devices of that kind contravene those prohibitions;
 (iab) if the kind of medical device is included in the Register in relation to the person and there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—whether any supplies in Australia, any imports into Australia, any exports from Australia or any manufacture in Australia of medical devices of that kind contravene those