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Chang-Hong Whitney11.12.07
Following a summer full of unfavorable press on China’s food and drug safety, the State Food and Drug Administration (SFDA) issued a new draft of top-level regulations pertaining to medical devices. Regulations for Supervision and Administration of Medical Devices (Revised Draft) was published on the agency’s Web site on Sept. 24. The SFDA now is soliciting public comments regarding this regulation before finalizing it into law, which is expected by the end of this year. When approved, it will replace the previous law with the same title issued in 2000.
Chang-Hong Whitney is president of Whitney Consulting Ltd. in Massachusetts. With an MBA from Babson College (Wellesley, MA) 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 changhong@whitneyconsulting.net.