30 January 2015 - China's regulatory framework for medical devices is undergoing radical changes and there could be new opportunities soon for device makers, according to a new report from Market Reports Online.

The country has seen sustained economic and population growth as well as an ageing population, and its healthcare market has maintained an annual average growth rate above 16% since 1990s. The medical devices segment has seen double digit growth, too.

In fact, by 2013 the total value of medical devices in the Chinese healthcare market reached RMB 179bn (USD 28.63bn). Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. 

It is estimated that Chinese medical device market will be likely to be more than RMB 340bn by 2015, and will surpass Japan to become the second largest medical device market behind the United States.

Starting from 1 March 2014, Chinese regulatory authority the China Food and Drug Administration has had a special examination and approval procedure for innovative medical devices.

This provides overseas companies with an opportunity to speed up the entry of overseas medical devices into the Chinese market, while reducing risks from registration examination uncertainty, and approval delays.

Within the Chinese medical device market currently, imported overseas medical devices made by overseas and multinational medical device manufacturers account for about a half of sales.

Most of this market share is from high-tech and high-valued medical devices, such as magnetic resonance imaging, CT. Sales of these devices in China are almost monopolised by GE, Siemens, Philips and other big, multinational companies.

However, this could change, given the regulatory changes recently enacted.

The Chinese Special Examination and Approval Procedures for Innovative Medical Devices are meant to speed up the entry of overseas innovative medical devices into the Chinese market.

These guidelines provide companies with a thorough knowledge of the latest Chinese special examination and approval procedures for innovative medical devices, and serve as a guide overseas and multinational medical device manufacturers on how to conduct practical operations in compliance with the latest Chinese regulations.

A related report from Market Reports Online, called "Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)," covers this subject in more depth.