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FDA goes to China

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 24, 2008

The FDA plans to place eight staff members in China to expand its efforts to ensure safety of medical devices, drugs, and food coming into the United States from international markets, the agency announced. If the Chinese government agrees to the staffing, the FDA will station the staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

The U.S. State Department granted approval to create the full-time overseas FDA positions. The FDA would also like to add five local Chinese staff to work with the new FDA staff.

The new positions enhance ongoing efforts to focus on the safety of devices and other FDA regulated products in global markets. The FDA's "Beyond our Borders" initiative seeks to improve FDA relationships and cooperation with its counterparts in other countries.

In December 11, 2007, the FDA and China entered into a Memoranda of Understanding to increase the safety of drugs and devices entering the U.S. from China. The agreement required Chinese manufacturers making certain drugs and devices intended for U.S. markets to register with China's State Food and Drug Administration. The two countries agreed to work together to share information, conduct joint training, and permit more FDA access to Chinese manufacturing locations.

In its March 14 press release, the FDA said increasing its presence in China with these new staff positions increases its ability to perform inspections and work with manufacturers to ensure foreign products meet U.S. standards.

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