Australia Therapeutic Goods (Medical Devices) Regulations 2002
Part 10: sponsor identification and custom-made device notices – Australia Therapeutic Goods (Medical Devices) Regulations 2002

Australia Therapeutic Goods (Medical Devices) Regulations 2002 r10.3-10.3A: Custom-made devices: notify the Secretary within 2 months of first manufacture in Australia or first import, and give an annual report on the approved form before 1 October covering all custom-made devices made or imported in the previous financial year

What does r10.3-10.3A require?

A manufacturer of a custom-made device made in Australia must, within 2 months after first making it, give the Secretary its name and business address and a description of the kinds of custom-made devices it makes, with their nomenclature codes; a sponsor importing a custom-made device must do the same within 2 months of first import, adding the overseas manufacturer's details. Each manufacturer and importing sponsor must also give the Secretary, before 1 October each year, a written report on the approved form covering all custom-made devices it made or imported in the previous financial year, including supply details the form asks for. Each failure is an offence (10 penalty units).

Maintained by Gerard Blokdyk

Other controls in Part 10: sponsor identification and custom-made device notices – Australia Therapeutic Goods (Medical Devices) Regulations 2002

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