As the after-market for priority vouchers reaches dizzying new heights with the latest voucher sale to Abbvie for $350 MILLION, perhaps it’s time to ask some hard questions about regulatory fees
Archives for August 2015
FDA has announced the new user fees for the coming (2016) Fiscal year with increases across the board and the continuation of the small business exemption scheme.
China has published its long awaited update to medical devices classification rules. The new rules follow much of the precedents of the GHTF rule set, but with some significant differences – not least of which is that they are applied by the regulator and not by the manufacturer.
The latest transition to on-line business for TGA brings CTN into the electronic age. Gone are the days of collecting signatures from ethics committee, investigators – all replaced with a simple online form and sponsor declaration.
In this second article on the Sansom Expert review we take a look at the recommendations for Devices regulatory reform. There’s a strong push to leveraging 3rd party and international regulatory reviews, and calls for registries for all implants,
Changes in 2014 allowed Australian manufacturers of medical devices for the first time to use CE certification to obtain an expedited regulatory approval in Australia. This pathway had been available to importers since 2002. Still confused by which devices can be marketed in Australia based on CE mark,? Read on…