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.17-4A.18: Australian conformity assessment bodies: certify only where an appropriate procedure has been applied, vary, suspend or revoke certificates when no longer satisfied, notify the Secretary within 10 working days of refusals, suspensions, revocations, variations and significant safety concerns, notify clients of changes to the determination, agree transfers with successor bodies and check for parallel applications

What does r4A.17-4A.18 require?

The body may certify a manufacturer only once it is convinced the right conformity assessment route was followed for the devices in scope. If that confidence is later lost, it must either change, suspend or withdraw the certificate straight away, or give the manufacturer written notice and a reasonable time to put things right, and then change, suspend or withdraw it if the problem persists. It must notify the Secretary within 10 working days when it refuses a certificate on that ground, suspends or revokes one, varies one in those circumstances, or becomes aware of a matter of significant safety concern about a certified device. It must notify clients within 10 working days if its own determination is varied or suspended, agree with a successor body the transfer of responsibility when a client moves, and, before accepting an application, make reasonable enquiries whether the manufacturer has applied to another Australian body for the same kind of device.

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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