Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_2
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 2
Character Range: 304982–306168

2                                                          The manufacturer's name, address and website

13A.3  Patient information leaflets etc. for implantable devices
 (1) Either:
 (a) a leaflet (a patient information leaflet) that includes the information covered by subclauses (2) and (3) and that satisfies subclause (4) and clause 13A.4 must be made available for provision to the patient concerned; or
 (b) information covered by subclauses (2) and (3) that is in electronic form and that satisfies subclause (4) and clause 13A.4 must be made available in a way that is readily accessible by the patient concerned.
 (2) The information covered by this subclause is the following information:
 (a) information identifying the device, or the kind of device;
 (b) the intended purpose of the device;
 (c) information explaining how to use the device safely;
 (d) other information about the device that the manufacturer considers would be useful for patients.
 (3) The information covered by this subclause is the information in the following table.

Information to be made available for provision to patient
Item                                                       Information