CFDA recently organized a 3-day training session on In Vitro Diagnostics Clinical Evaluation and Trials in Beijing. Around 200 industry professionals participated in the event. Representatives from Brandwood Biomedical Beijing joined this session. Key discussions include: Review on In Vitro Diagnostics regulations Requirements on In Vitro Diagnostics Clinical Evaluation Overview of In Vitro Diagnostics Clinical […]
At the March 2018 Shanghai meeting of IMDRF, new work item proposals from China on GCP practices and the update of technical standards were approved. These seemingly routine administrative efforts mask a radical change – with China for the first time taking the lead on IMDRF harmonization efforts and seeking to promulgate its own approaches into global regulation. We take a look at what’s really going on.
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?
CFDA held a press conference in September to announce the implementation of the updated Devices classification catalogue, which takes effect next August. It’s a very substantial overhaul and some manufacturers will find themselves needing to re-register at higher classification. Is your device reclassified?
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….