We are delighted to confirm that the forthcoming Asia Pacific Device Summit will feature a presentation by Yongheng Chang of China Food and Drug Administration. Mr Chang will speak on China’s Policies to support Medical Device Innovation including navigating the Innovative Device Pathway for CFDA approval, He will also provide an up to the minute […]
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.
China’s CFDA released draft regulation changes in October with far reaching proposals including faster Clinical trial approvals and abolition of Type Testing. At the same time CFDA is getting tougher in postmarket supervision. This could all be law by Chinese new Year.
There’s been a lot of focus on the process for re-designation of Notified Bodies in Europe – so that we can all start the process of certification to the new Medical Device and IVD regulations. But what happens if your Notified Body fails to achieve re-designation, or has its scope narrowed – or just gives up and goes away?
As Indian Central Drugs Standard Control Organization counts the days to the January 2018 start date for the new Indian Medical Device regulations, the Asian Harmonisation Working Party meet in New Delhi from 4-8 December. We will be there.
US FDA releases draft guidance on expedited review for breakthrough devices – and they want access to your wordprocessor and to chat a lot by phone! We take a look at how FDA wants to roll up its sleeves and work with device developers.