Australia Therapeutic Goods (Medical Devices) Regulations 2002
Part 4 and Part 4A: conformity assessment certificates and Australian conformity assessment bodies – Australia Therapeutic Goods (Medical Devices) Regulations 2002

Australia Therapeutic Goods (Medical Devices) Regulations 2002 r4A.10-4A.16: Australian conformity assessment bodies: comply with Schedule 3AA, tell the Secretary of substantial changes within 10 working days and of planned cessation, allow entry and inspection (and bind contractors to allow it), produce information within the notice period, cooperate with reviews and keep compliance records

What does r4A.10-4A.16 require?

Every conformity assessment body determination carries automatic conditions. The body must comply with Schedule 3AA (the adapted EU notified body requirements); notify the Secretary within 10 working days of any substantial change affecting that compliance; notify the Secretary and affected clients as soon as practicable, with a date, if it plans to stop any certification activity; let an authorised person enter its premises at reasonable times to inspect, record and copy documents on certification activity, and have written agreements requiring its contractors to allow the same; give information or documents the Secretary asks for within the stated period (at least 20 working days) and have agreements requiring clients and contractors to make information available; cooperate with any review of its activities or compliance; and keep the records Schedule 3AA requires and any others needed to show continuing compliance. Breach of a condition attracts offences and civil penalties under sections 41MN and 41MNA of the Act, and specified conditions may be added.

Maintained by Gerard Blokdyk

Other controls in Part 4 and Part 4A: conformity assessment certificates and Australian conformity assessment bodies – Australia Therapeutic Goods (Medical Devices) Regulations 2002

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