Summary of technical reports accepted by TGA
Australian companies have been facing difficulties in obtaining examination evidence from European notified bodies. On these grounds, Australia’s Therapeutic Goods Administration (TGA) has announced that the agency is ready to accept summary technical reports from device manufacturers. The report can be treated as interim evidence for supporting applications for reclassification of partial hip, knee and shoulder implants from Class IIb to Class III.
As required by TGA, the summary of technical reports should show that the European notified body has thoroughly assessed the device and has an opinion that the device meets all the relevant guidelines given by TGA according to the Essential Principles of the Therapeutic Goods (Medical Devices) Regulations.
All companies, whose medical device is assessed by a European notified body as a Class IIb device needs to submit to the TGA, a reclassification application before 30 June 2014. Also, following the submission of application, the company will also need to submit a design examination application within 12 months to follow.