TGA Says Interim Assessment Evidence Acceptable for Joint Reclassification
Citing the difficulties faced by Australian companies trying to obtain examination evidence from European notified bodies, Australia's Therapeutic Goods Administration (TGA) announced on 17 January 2014 that it will accept summary technical reports as interim evidence to support applications for reclassification of partial hip, knee and shoulder implants from Class IIb to Class III.
The summary technical reports must demonstrate that the European notified body properly assessed the device and is of the view that the device meets all the relevant Essential Principles of the Therapeutic Goods (Medical Devices) Regulations.
In order to take advantage of this exception, a company whose device was assessed by a European notified body as a Class IIb device must submit a reclassification application to the TGA in time for the agency to receive the application before 30 June 2014. Moreover, a company that submits its application in a timely manner will be required to submit a design examination application within the following 12 months.
TGA developed the interim solution in conjunction with the Medical Technology Association of Australia (MTAA), it said.