Administrative processes (Parts 4‑4 to 4‑10)
41BB Administrative processes (Parts 4‑4 to 4‑10)
The administrative processes under this Chapter are:
issuing conformity assessment certificates for some manufacturers of medical devices; and
making conformity assessment body determinations; and
including medical devices in the Register; and
suspending or cancelling entries of medical devices from the Register; and
exempting medical devices from various provisions of this Chapter to deal with emergency situations; and
exempting medical devices from the requirement to be included in the Register; and
obtaining information about medical devices; and
requiring public notification of problems with medical devices, and recall of such devices.
Part 4‑10 provides for assessment fees to be payable in some circumstances.
This Act’s bill:Second reading speech
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