Australia Therapeutic Goods (Medical Devices) Regulations 2002
Part 5 and Part 6: inclusion in the Register and automatic conditions of inclusion – Australia Therapeutic Goods (Medical Devices) Regulations 2002

Australia Therapeutic Goods (Medical Devices) Regulations 2002 r5.13: Automatic condition: do not supply in Australia a device containing a scheduled poison where that supply would breach Part 2 of the current Poisons Standard

What does r5.13 require?

Where a kind of device contains a substance covered by a Schedule to the current Poisons Standard (and Appendix A does not exclude devices of that kind), the sponsor must not supply it in Australia if doing so would contravene Part 2 of the Poisons Standard (for example its labelling, packaging and container rules). The parallel condition on conformity assessment certificates binds the manufacturer (regulation 4.3G).

Maintained by Gerard Blokdyk

Other controls in Part 5 and Part 6: inclusion in the Register and automatic conditions of inclusion – Australia Therapeutic Goods (Medical Devices) Regulations 2002

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