The TGA announced in November 2010 proposed reforms to the medical device regulatory framework. In response, the Government decided to reclassify both total and partial hip, knee and shoulder joint replacement implants from Class IIb (medium-high-risk medical devices) to Class III (high-risk medical devices).
With the two-year transition period (1 July 2012 to 30 June 2014) already underway, that doesn’t leave much time to finalise transition plans.
Both total and partial implantable hip, knee and shoulder joint replacements, intended to replace a natural articulating surface of these joints, have been reclassified. This does not, however, capture other implantable components or accessories such as screws, pins or wedges, which may supplement or assist the joint replacement implant’s function.
Waivers and discounts
As an incentive in the first-year transition period (ending 30 June 2013), sponsors who lodge transition applications for Class III medical devices will have each application fee ($1,150 at 2012-13 rates) waived. Annual fees will also receive concessions in this period. Furthermore, mandatory application audits of transitioning devices will not be undertaken during the two-year transition period. Random audits, however, may still apply on a case-by-case basis.
While it would be ideal to take advantage of these financial incentives and transition in the first year, you may not have the necessary time or resources, especially if you currently group several similar devices under one ARTG entry (Reclassification requires a separate ARTG entry for each device).
With our experience in the regulation of medical devices, why not let Commercial Eyes manage the transition? We have efficient and reliable consultants ready to take on your project, regardless of the number of devices involved.
If you would like to further discuss your transition needs with one of our experts, and avoid having the TGA cancel your products at the end of the transition period, please contact Jeanette Lodge who will ensure you meet the deadline.