By Stewart Eisenhart, Emergo Group
The Australian Therapeutic Goods Administration (TGA) has officially ended the three-year transition period for manufacturers of certain joint replacement devices to apply for reclassification of their products from Class IIb to Class III.
Originally scheduled for July 1, 2014, the TGA deadline for reclassification was extended to July 1, 2015. Now, any manufacturer of total or partial hip, knee or shoulder joint replacements must apply for inclusion in the Australian Register of Therapeutic Goods (ARTG) as a Class III high-risk medical device manufacturer if the firm wants to sell its product in Australia. Any such devices that were registered as Class IIb devices before the transition but that did not apply for reclassification to Class III by the deadline will be delisted from the ARTG.
As reported by Emergo, the TGA initiated the reclassification of these joint replacement devices in 2012 in order to implement more rigorous premarket assessments of safety, quality and performance following concerns about joint implant malfunctions posing significant public health risks.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.