The annual TGA Sponsor Information day provides a focused full day program on Australian regulatory requirements. here from TGA officials and leading industry experts on how it all works. Still time to register….
Sponsors of AIMD, Class III, IIb implants and Class 4 IVDs are required to submit annual postmarket reports to TGA for 3 years after first registration. Failure to do so is an offense and risks cancellation of the registration. The deadline for this year’s reports is drawing close.
This week Australia’s TGA issued letters to multiple sponsors calling in technical data on custom surgical implants. The agency is taking a closer look at the evidence held by manufacturers for safety and performance of custom devices. This will inform TGA’s planned reforms for regulation of advanced manufactured devices. In the short term, those without adequate data may be in for an uncomfortable time.
TGA acts on promise to streamline special access – removing duplication of ethics committee review of clinical need and extending the duration of approvals. There’s also a new Special Access C – which sets up notification only pathways for medicines and devices with accepted history of use.
Time is running out for Prosthesis list applications. Manufacturers seeking reimbursement from February next year must act now or wait until August 2018 before they get paid for implantable devices. Opportunity knocks but twice a year. There’s still time to get your listing application in but be quick
Manufacturers who have TGA registrations but haven’t yet started sales can claim relief from TGA annual charges – but only if they act very quickly. The window for applications closes on 22 July