5Kind of information—medical devices other than IVD medical devices

5 Kind of information—medical devices other than IVD medical devices

Class I medical devices (1A) An application for a Class I medical device that the manufacturer intends to be supplied in a non-sterile state and that does not have a measuring function must be accompanied by the following kind of information: (a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 1 of Part 1 of Schedule 1, which is recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (1) An application for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function 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 Division 2 of Part 1 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. (2) To avoid doubt: (a) for the purpose of subsection (1), an application may be accompanied by more than one document referred to in paragraph (1)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (1)(b) (if any); (b) a document which accompanies an application in accordance with subsection (1) or (1A) must relate to the kind of device to which the application relates. Class IIa medical devices (3) An application for a Class IIa 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 2 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. (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.