Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_13:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 13 (pt 1/2)
Character Range: 290752–293516

13  Information to be provided with medical devices

13.1  Information to be provided with medical devices—general
 (1) The following information must be provided with a medical device:
 (a) information identifying the device;
 (b) information identifying the manufacturer of the device;
 (c) information explaining how to use the device safely;
having regard to the training and knowledge of potential users of the device.
 (2) In particular:
 (a) the information required by clause 13.3 must be provided with a medical device; and
 (b) if instructions for use of the device are required under subclause 13.4, the information mentioned in subclause 13.4(3) must be provided in those instructions.
 (3) The information:
 (a) must be provided in English; and
 (b) may also be provided in any other language.
Note: The information may also include diagrams or drawings.
 (4) The format, content and location of the information must be appropriate for the device and its intended purpose.
 (5) Any number, letter, symbol, or letter or number in a symbol, used in the information must be legible and at least 1 millimetre high.
 (6) If a symbol or identification colour that is not included in a medical device standard is used in the information provided with the device, or in the instructions for use of the device, the meaning of the symbol or identification colour must be explained in the information provided with the device or the instructions for use of the device.

13.2  Information to be provided with medical devices—location
 (1) Unless it is impracticable or inappropriate to do so, the information required to be provided with a medical device must be provided on the device itself.
 (2) If it is not practicable to comply with subclause (1) in relation to the provision of the information, the information must be provided:
 (a) on the packaging used for the device; or
 (b) in the case of devices that are packaged together because individual packaging of the devices for supply is not practicable—on the outer packaging used for the devices.
 (3) If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under subregulation 10.2(1) or clause 13.3:
 (a) for a medical device that is not software—the information must be provided on a leaflet supplied with the device; or
 (b) for a medical device that is software—the information must be provided on a leaflet supplied with the device or the information must be provided electronically.
 (4) If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under clause 13.4, the information must be provided in a printed document or using other appropriate media.

13.3  Information to