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 r5.9: Automatic condition: store and transport devices under the sponsor's control in line with the manufacturer's instructions for use and accompanying information

What does r5.9 require?

While a device is under its control, the sponsor must ensure it is stored and transported as the manufacturer's instructions for use and other information supplied with the device require. This reaches warehousing, cold chain, third-party logistics and loan kits under the sponsor's control.

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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll Australia Therapeutic Goods (Medical Devices) Regulations 2002 controls