The QMN Weekly Bulletin

U.S. Gets Access to Chinese SFDA Inspection Information

Jan. 25, 2008
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China’s State Food and Drug Administration (SFDA) will provide the FDA with access to records from inspections and a list of manufacturers who do not meet Chinese standards.

The agreement is part of a memorandum of understanding between Chinese authorities and HHS under which China will certify the safety of its exported medical devices and create product-tracking systems.

In the device sector, the agreement only applies to condoms and glucose test strips, but HHS expects to expand its scope to cover other devices, the department said.

All manufacturers of SFDA-regulated products must register with Chinese authorities who will supply that information to the FDA in exchange for a list of all firms registered to manufacture devices and drugs in the U.S.

China’s SFDA also will work to create a system that allows it to certify that firms and their products will meet FDA requirements. The U.S. and China will conduct joint training programs to discuss inspection methods, clinical trials for safety and the development of technical guidance documents and regulations.