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Compliance In Focus
Posted by John Lehmann on Thu, Apr 11, 2013

Be Ready to Compete if You Enter the Chinese Market

Be Ready to Compete if You Enter the Chinese MarketWith market growth stalled in the U.S., European and Japanese markets, medical device companies are seeking entry into new markets.  According to an article in MD+DI, many companies are now looking to China as the next growth market.  On paper, this seems like a logical move.  China is a huge market that is growing with rising incomes and health care needs.

According to this website, the Chinese Food and Drug Administration (CFDA) have drafted a regulation that would fast track approvals for innovative medical devices.  In addition, according to an article in MassDevice, “life sciences companies that are ready to evolve along with China's shifting landscape will be in the best position to capitalize on what's projected to become a $1 trillion healthcare market within the decade.” This sounds like great news for medical device manufacturers who want to enter the market. 

However, when you read the fine print you discover that the regulation drafted by CFDA only pertains to domestic manufacturers.  A key criteria is that the core technology must be registered China as an invention patent that the manufacturer owns or is licensed to use, according to law firm Ropes & Gray.

This seems to fit into China’s long-term plans.  As outlined in the 12th Five-Year Plan for Medical Technology.  This document outlines the government push for technology in the medical sector, with the goal of hiring people.

So what seems like a prime opportunity for medical device companies in China might turn out to be a stacked deck against firms.  The governments master plan is to narrow the technology that exist between foreign and local manufacturers.

What are your thoughts on entering the Chinese market?  Given the market opportunity, is it worth the risk of fighting against companies who have a significant advantage?  Share your thoughts below.

Photo Credit: Duncan Rawlinson

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Topics: China Market, Chinese Food and Drug Administration, Medical Device Industry


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