The new European MDR and IVDR require that all devices are re-qualified – no grandfathering here. So how much clinical data is enough for established devices? European guidance is in the works. It’s time to speak to your Notified Body.
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….
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.
Recent announcements from CFDA suggest that China is thinking again on the stringent requirements for manufacturers to conduct in-China clinical trials. The agency is accelerating the production of exemption lists and recent draft policy circulars open the door to acceptance of foreign clinical data and to post market trials of devices which address unmet clinical need. Is the pendulum starting to swing back?
At long last China’s CFDA is moving on exemption of IVDs from in China trials with publication of a first list of Class II diagnostics proposed for approval without in-China clinical data.
On 17th May 2017, China FDA published a draft ‘Exemption List of Local Clinical Trial for Class II & Class III medical devices’. This is open for industry and user feedback with a deadline of 20th June 2017.
This will be the 3rd wave exemption list in China.