Even though China's medical device regulations have evolved greatly over the past two decades, navigating the Chinese regulatory system is still a daunting task for many western companies. Reforms are progressing (albeit slowly), and western device manufacturers are getting ready to take advantage of what they see as a bonanza.
Two factors are contributing to this belief of golden times ahead in China. First, the new regulations aim to increase the quality of domestic production. This push towards quality may, however, drive domestic production down as Chinese manufacturers struggle with rising costs of production. According to Market Realist, the quality of many made-in-China devices is poorer compared to imported products. These poorer-quality products may be pushed out of the market, making room for other manufacturers.
In fact, problems and complaints associated with the use of medical devices are widespread:
"In 2012 there were 180,000 reports of such problems, according to the China Food and Drug Administration (CFDA). The number of incidents per million people has been climbing since 2009 and jumped 49% to 137 from 2011 to 2012."The second factor is captured in this graph, also from the Market Realist article:
With billions of dollars at stake and a perceived quality advantage over local manufacturers, it is no wonder that western medical device companies are racing east!
For more information on China, take a look at the following:
- Chinese healthcare reform creates gold rush mentality
- China announces new medical device regulations
- Language facts: Chinese
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