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Compliance In Focus
Posted by John Lehmann on Wed, Apr 23, 2014

China-Made Device Knock Offs a Source of Concern

Medtech companies in the U.S. are concerned about Chinese device manufacturers stealing China Made Device Knock Offs a Source of Concerntheir intellectual property and making knock-offs that replicate American devices.  However, these devices are not as safe according to Advamed.

Ralph Ives, Executive Vice President, Global Strategy & Analysis for Advamed official told the U.S. – China Economic and Security Commission that “we are very concerned about [Chinese] products that may look like company X’s product – but do not perform like company X’s product – because that may mean patient safety is companies.”

Ives explained that when Chinese firms make forgeries of products based on American device makers’ IP, they can skip the expense of research and development costs.  This allows them to sell devices at lower costs and can create a negative perception of manufactures globally.

China’s FDA has recently signaled it is trying to better police manufacturers’ forgeries, which can range from submitting fake clinical data and undocumented manufacturing during product registration, to participating in illegal distribution. 

This is occurring while substantial trade barriers exist for domestic firms trying to sell their devices to China Hospitals.  China FDA’s requires excessive amounts of proprietary data from U.S. manufactures that apply for registration of devices already approved in the U.S.   Another barrier is the price ceilings imposed selectively on products made outside of China.

Advamed is very concerned according to Ives. “As the Chinese government gets more and more involved in the purchase of medical devices, and word comes down from the government, we are very concerned about discrimination.”

What can be done to combat the increase in knock-off devices and unfair trade barriers that China has put in place?  Share your thoughts with us.

Photo Credit: Sam UL

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Topics: Medical Devices, AdvaMed, China-Made, Kock Offs, Ralph Ives


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