Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_9
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 9
Character Range: 309161–310274

9                                                          (a) a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration; and
                                                           (b) the address of the Therapeutic Goods Administration's website

 (4) The information covered by subclauses (2) and (3) must be written in a way that is readily understood by patients.

13A.4  General requirements for information to be made available for patients
 (1) The information covered by subclause 13A.2(2) or 13A.3(2) or (3):
 (a) must be included in English; and
 (b) may also be included in any other language.
Note: The information may also include diagrams or drawings.
 (2) Any number, letter or symbol, or letter or number in a symbol, that is part of the information covered by subclause 13A.2(2) or 13A.3(2) or (3) must be:
 (a) legible; and
 (b) if the number, letter or symbol, or letter or number in a symbol, is included in a patient implant card or patient information leaflet—at least 1 millimetre high.