China’s top medical regulatory agency, the State Food and Drug Administration (SFDA), has designated 2009 as the year to broaden and strengthen quality management systems and technical standard systems. It plans to enhance the technical testing capabilities and expand the technical evaluation infrastructure for product approval and re-evaluation. The 2009 objective for SFDA is to elevate the overall level of supervision and management of medical products in China. This year also will see more activities in adverse event and product recall areas.

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After a few years of turbulence and restructuring, SFDA seems to have found its direction and is making steady improvement. The agency seems to have grown out of its infancy into a more mature stage, where more systematic thinking and logical steps may have a chance to take hold. By its nature, however, China will remain unique in every aspect. Those of us operating in the medical market always must keep our eyes and ears open for the changes to come.

Chang-Hong Whitney is president of Whitney Consulting Ltd. in Massachusetts. With an MBA from Babson College (Wellesley, Mass.) and undergraduate degrees in electronic engineering and international business, she has been consulting for western companies on doing business in China since 1994, focusing on the medical device market. Her services include China regulatory affairs, market research, sourcing and logistics programs and China business strategies. She can be reached at [email protected].