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. However as with all statistics the story’s never so simple. For sure the total revamp and toughening of Chinese regulations may have discouraged some applicants. However the figure of 8,340 in 2013 was unusually high – and probably represented a last minute dash to register products before the start of the new regulations in 2014.
We have certainly seen these sorts of reactive peaks and troughs before (See this more detailed analysis of the situation just over a year ago). Seen that way, the current year looks more like a return to business as usual.
The CFDA report is full of statistics about the numbers of registrations sliced and diced by type of device, class and by imports vs domestic manufacturers.
A couple of things are striking:
The proportion of IVDs in the figures is large – around 40% overall, but that’s not consistent. Take a look at 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.
Only 326 new imported IVDs were registered in 2015 – that’s 18% of total registrations.
Yet the Chinese domestic IVD industry appears to be thriving. The CFDA report also takes a look at some of the more notable innovative technologies approved in 2015 through the so called Green Channel, A number of these were domestically developed IVDs.
|US Biological Group Co., Ltd.||Microfluidic nucleic acid analyser||IVD analyser|
|Anil Cornea Shenzhen Engineering Co Ltd.||Acellular corneal stroma||China’s first artificial cornea|
|Yu Jing Suzhou Medical Devices Co., Ltd.||dual-channel implantable deep brain stimulation pulse generator kit,||Advanced idiopathic Parkinson’s|
|Xi’an Golden Magnetic Nano Biotechnology Co., Ltd||MTHFR C677T gene detection kit (PCR)||Diagnosis of high levels of homocysteine or folate metabolism|
|Bor Cheng (Beijing) Technology Co., Ltd.||Septin9 gene methylation detection kit (PCR)||Diagnosis of colorectal cancer|
|Corning (Tianjin) Medical Equipment Co., Ltd.||digital breast X-ray tomography||China’s first true 3D breast imaging for differential diagnosis of breast disease|
|Shanghai colored stone Medical Research Ltd.||Survival motor neuron gene 1 (SMN1) exon deletion detection kit (quantitative PCR)||Diagnosis of spinal muscular atrophy (SMA)|
It’s an annual sport trying to divine significance from these high level reports. Of course there’s so much going on under the surface that it’s difficult to draw hard and fast conclusions about trends. What is clear, despite the complete overhaul in regulations and the increase of substantial fees (including a surcharge for importers), there’s still a strong appetite for the Chinese market.
Exporting to China? Don’t know where to start? Already there but finding it a challenge? So successful that you are overloaded? We can support CFDA submissions through our direct office in Beijing and also our Mandarin/English bilingual staff in our Sydney office. We’re also expert in Taiwan registrations. Contact us to discuss your needs for China regulatory approvals. Email firstname.lastname@example.org or call +61 2 9906 2984 (Sydney) or + 86 (10) 8532 5809 (Beijing)