Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsFor the purposes of subsection 41BG(4) of the Act, a class of persons is health professionals, or suitably qualified persons within a healthcare facility, who produce a medical device (the final device ) where the following are satisfied:
(a) a medical device production system is used to produce the final device;
(b) the medical device production system is included in the Register as a kind of medical device.