Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:3_5:p2
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 3 cl 5 (pt 2/3)
Character Range: 13864–16644

the regulatory authority in column 2 of that item.
 (4) To avoid doubt:
 (a) an application may be accompanied by more than one document referred to in paragraph (3)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (3)(b) (if any);
 (b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates.
 Class IIb medical devices
 (5) An application for a Class IIb medical device must be accompanied by the following kind of information:
 (a) a conformity assessment document that relates to the manufacturer's quality management system specified in column 3 of an item in the table in Part 3 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and
 (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.
 (6) To avoid doubt:
 (a) an application may be accompanied by more than one document referred to in paragraph (5)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (5)(b) (if any);
 (b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates.
 Class III medical devices
 (7) An application for a Class III medical device must be accompanied by the following kind of information:
 (a) a conformity assessment document that relates to the manufacturer's quality management system specified in column 3 of an item in the table in Part 4 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item;
 (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item;
 (c) if the application is not accompanied by a conformity assessment certificate issued by the TGA—a clinical evaluation report and the instructions for use.
 (8) To avoid doubt:
 (a) an application may be accompanied by more than one document referred to in paragraph (7)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (7)(b) (if any);
 (b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.

        Application of this section

        (11) This section does not apply to any of the following:
           (a) a medical device used for a special purpose;
           (b) a medical device that is intended by the