New Guidebook Released for Imaging Regulation and Approval Procedures in China

The Chinese healthcare market is one of the largest in the world and has seen annual average growth of more than 16% since the 1990s. At the same time the Chinese medical device market started growing rapidly from the year 2000, and was valued at RMB 179 billion in 2013. The medical device market is expected to continue to grow to more than RMB 340 billion by 2015 becoming the second largest market in the world after the United States.

About half of the medical device market in China are supplied by international manufacturers such as Royal Philips (Amsterdam, the Netherlands), GE Healthcare (Chalfont St Giles, Buckinghamshire, UK), and Siemens Healthcare (Erlangen, Germany). These manufacturers supply almost all high-end Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) devices.

The guidebook was released by Bharat Book Bureau (Poonam, India) and is intended to aid international medical device manufacturers in understanding the latest China Food and Drug Administration (CFDA; Beijing, China; eng.sfda.gov.cn/) special examination and approval procedures for innovative medical devices. The guidebook lists which devices are included, explains local medical device regulations, how to apply for registration of devices, and how to comply with Chinese regulations.

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Bharat Book Bureau
GE Healthcare
Siemens Healthcare