In May, the Chinese State Food and Drug Administration (SFDA) issued a new policy, No. [2006] 259, which mandates that all medical electrical and electronic products must comply immediately with GB9706.1-1995 Medical Electrical Equipment – Part 1: General Requirements for Safety. While this measure was viewed as another step to strengthen control over product safety, and a continuing effort to comply with international standards, the implementation of this policy by the SFDA has been challenging.

During the past two months, in working with products that have been affected by this regulation, the experience was anything but smooth. What follows is some personal knowledge and experience with dealing with this policy, but it should be noted that in spite of the issues being raised here, future development and refinement about this regulation and the compliance process are anticipated and will be covered in future issues of this magazine.

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 [email protected].