The Australian Therapeutic Goods Administration (TGA) will, as a rule, be carrying out audits of applications for registration in the Australian Register of Therapeutic Goods (ARTG) in which certain Notified Bodies have been involved. Manufacturers affected by this decision can expect significant delays in the registration of their Medical Devices. The TGA published a list of eight Notified Bodies as well as detailed information on the increased audits on its website.
This measure is being taken in reaction to a 2012 article in the British Medical Journal, which named these eight European Notified Bodies in connection with a hip prosthesis scandal. All applications which are supported by certificates from these Notified Bodies will be affected by this change. In conducting these audits, the TGA wants to assure the quality of certificates and reports. For a list of the Notified Bodies and more information on the increased audits, see the TGA website.