CFDA update – fewer registrations – but look at all those IVDs
03-May-16, Brandwood Biomedical
The CFDA 2015 annual report issued in April details a fall last year in the registration of new Medical devices to 7,530 from 8,340 in 2014. For sure the total revamp and toughening of Chinese regulations may have discouraged some applicants. However the figure in 2013 was unusually high – and probably represented a last minute dash to register products before the start of the new regulations in 2014.
%20Brandwood%20Biomedical.png "CFDA update fewer registrations but look at all those IVDs (c) Brandwood Biomedical")
Image: Brandwood Medical
The proportion of IVDs in the figures is large – around 40% overall, but that’s not consistent. In the breakdown of registrations of imported devices in 2015 it can be seen that for medical devices there’s a healthy renewal going on, with almost as many new registrations as renewals. In the IVD world, not so many.