China abre el centro para los estándares médicos del dispositivo

por Brendon Nafziger, DOTmed News Associate Editor | April 19, 2010
Tightening regulatory controls
Chinese officials cut the ribbon on a new center for medical device standards last month, promising to improve device safety and promote the country's nascent medical device industry.

The center, called the Management Center for Medical Device Standards of SFDA, was unveiled March 30, during an opening ceremony at the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP).

Zhang Jingli, deputy commissioner of the State Food and Drug Administration (SFDA), China's counterpart to the U.S. FDA, made a speech at the ceremony, announcing that his agency would work to establish a better medical device standards system to encourage growth of the domestic Chinese device industry and protect consumers.

China has 180 national standards, 727 industrial standards and 22 technical committees for medical devices, according to the SFDA website.

But China's system for regulating medical devices is new, according to the U.S. Department of Commerce, with the basic law governing the field passed in 2000.