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….
Last week the US FDA announced a new web page setting out its current Small Business Program. This program provides fee breaks for small businesses seeking FDA regulatory approvals. The fee breaks are substantial (up to 75% off) and a business doesn’t have to be all that small to qualify. Non US businesses can apply too.
Presentations from CFDA leadership at the CIMDR meeting in Hangzhou point to continuing reform in Type Testing requirements, clinical trials supervision, device classifications and review processes. We take a look at the key messages from CFDA on China’s regulatory reform program.
Abolition of Type Testing Fees in China appears to have led to a hiatus, with many test centers stopping Type Test Services. Does this indicate an impending policy change on Chinese Type Testing?
A recent training session to CFDA’s Center for Medical Device Evaluation raised a surprising plea. The agency is very open to risk based submissions for biocompatibility – but industry keeps on sending dossiers of test reports. So there you have it- CMDE have built it – will you come?
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.