In mid-July, TGA updated the Standard Conditions of ARTG registration and hard wire them into the regulations. They are no longer needed to be included on each certificate and will be much more consistently applied – and policed. Standard conditions matter. This may seem like boring regulatory small print, but standard conditions set up real world obligations which if not met provide straightforward grounds for regulatory action. At a minimum, breach of any of these conditions constitutes grounds for cancellation of a product registration. In serious cases criminal or civil penalties may apply.
An area we see regular problems is device suppliers struggling to achieve transfer of sponsorship in the case of changes in distribution arrangements or other corporate restructures. TGA has a simple process where a sponsorship can be transferred to a new owner providing both parties sign off on the transfer. But if the current sponsor refuses to sign, this can lead to a world of pain and quite likely a need to start the whole regulatory process again to establish a new registration causing a delay on continued supply to market. There is no alternative if the existing sponsor cancels the entry.
As June 30 approaches in the depths of the Australian Winter, manufacturers should do a little early Spring cleaning. Any registration which are no longer needed should be cancelled – or you will be liable for another Annual Fee. Time to clean house…
Australia’s Therapeutic Goods Administration (TGA) has introduced new regulations to require online notification within 2 months of Australian manufacture or the importation of a custom made device. Custom devices are wide ranging from simple dental appliances to 3D printed implants. Read on to learn about the TGA requirements or join a workshop on 3D printing in medicine.