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 r5.12: Automatic condition: for higher-risk IVDs, self-test and point-of-care IVDs and spinal fusion implants, notify the Secretary at least 20 business days before importing, supplying or exporting a device whose product name or intended purpose is not on the Register

What does r5.12 require?

For Class 3 and 4 IVDs, Class 4 in-house IVDs, IVDs for self-testing or point-of-care testing, and spinal fusion implantable devices (screws, cages, plates, hooks, rods and similar), a sponsor planning to bring in, supply or send out a device whose product name, or the manufacturer's statement of intended purpose, is missing from its ARTG entry must tell the Secretary in writing what is missing at least 20 business days ahead of that dealing.

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