Relevant legislation

The legislation applicable to in-house IVDs is:

• Therapeutic Goods Act 1989
• Part 6A, Schedule 3, of the Therapeutic Goods (Medical Devices) Regulations 2002 (for Class 1-3 in-house IVDs)
• Part 1 or Part 6B, Schedule 3, of the Therapeutic Goods (Medical Devices) Regulations 2002 (for Class 4 in-house IVDs)