Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_14
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 14
Character Range: 295479–296282

14    If applicable, the words 'for export only'

Note: In addition to the information mentioned in the above table, regulation 10.2 requires certain information to be provided with a medical device.

13.4  Instructions for use
 (1) Instructions for the use of a medical device must be provided with the device.
 (2) However, instructions for the use of a medical device need not be provided with the device, or may be abbreviated, if:
 (a) the device is a Class I medical device, a Class IIa medical device or a Class 1 IVD medical device; and
 (b) the device can be used safely for its intended purpose without instructions.
 (3) Instructions for the use of a medical device must include information mentioned in the following table that is applicable to the device.

Item  Information to be provided