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Thomas Dworetzky, Contributing Reporter | January 19, 2017
These devices require a technical review by the Center for Device Evaluation under the CFDA or at the provincial level.
According to the law firm Ropes & Gray, CFDA has also established expedited approval for devices needed for emergency public health incidents and that are innovative.
The Medical device market is a massive opportunity in China. According to Medtec, a technology news and event site, “in developed overseas markets medical devices and equipment account for 42 percent of the overall market size of pharmaceuticals and devices/equipment combined whereas in the local Chinese market the share of medical devices and equipment is just 14 percent.”
The potential to grow the local Chinese medical device sector is therefore “huge,” according to the company.
China’s medical device market is growing, despite some headwinds. According to market research firm
Emergo, “China's economic growth is slowing down, but the medical device industry is still on the rise. The Chinese medical device industry was valued at $18.8 billion in 2016 and is projected to grow modestly through 2019, when it should reach over $24 billion.”
Evidence of growing interest in the medical device sector also comes from the increased participation in Medtec's China 2016, which took place in October 2016, in Shanghai. There were 302 exhibitors from 23 countries with 51 firms at the show for the first time.
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