China Keeps Ban on Used Medical Devices

by Barbara Kram, Editor | September 28, 2005

China's protectionism and
self-interests have made
free trade difficult

September 28, 2005 -- The U.S. Department of Commerce informed DOTmed news today that China will retain its current official ban on the importation of refurbished medical equipment and will cancel proposed regulatory changes that would have opened the market.

According to Matt Englehart, Communications Director for manufacturing & services for the U.S. Department of Commerce's International Trade Administration, "The DOC was informed by SFDA [China's parallel to our FDA] during our Medical Device Task Force meeting on August 30 that they received significant negative comments from local Chinese industry and have decided not to implement these proposed regulations."

The meeting in question was of the U.S.-China Joint Commission on Commerce and Trade (JCCT). "China does not currently have plans to change the existing policy banning imported used medical devices," Englehart confirmed.

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Although a translation is not available from the U.S. Government, on August 11, 2005, DOTmed reported a general overview of the proposed rules -- which would have given OEMs a significant role in ensuring and certifying the safety of any refurbished equipment sent to China. News about this issue is hard to come by. A recent IAMERS's newsletter reported that "the OEMs convinced the Chinese that only OEM-approved, and inspected, equipment should be sold into China." The Chinese have since backed off that position.

According to Chinese trade consultant Hong Kosalos of
Tradeology USA, the ban is the result of past safety problems; protecting trade may also be a motivation. "The [Chinese] government will protect those Chinese manufacturers from outside competition from refurbished equipment," Hong predicted in a July interview with DOTmed. At the time it was thought that devices not made in China would be allowed to be imported in refurbished condition.

Regardless of the ban, DOTmed records suggest that some used equipment is still being sold to China. The DOTmed website, which gets over 10,000 visitors a day, has a number of registered users from China who are active.