During summer’s hot days, certain manufacturers in China were feeling the heat in a different way. Poisonous ingredients were found in both cough syrup and toothpaste manufactured in China, and toy giant Mattel issued a recall of nine million of its toys made in China after the company determined paint on the products contained lead, which can be toxic. Meanwhile, the medical community had its own reasons to feel jittery with the execution of the former head of the State Food and Drug Administration (SFDA) and arrests of other high-level officials in healthcare and regulatory agencies due to bribery and mismanagement. The leadership changes and shuffling of personnel within the SFDA and local agencies left many bewildered as to the SFDA’s future direction.

For those of us in the regulatory arena, while frustrated with the indecision and slow pace of the agency on many crucial issues, we were happy to see increased attention paid to regulatory compliance and emphasis on quality management by top leaders in the government. China is not ignorant of the concept of quality control, and standards have been in place for some time now—one can find a small inspection card or sticker attached to each product on the market, indicating that the product has been examined by an inspector prior to shipment. However, the overall management system for quality, which has been the guiding principle of many successful companies in the rest of the world, has been fairly new to Chinese businesses. The medical device industry’s rapid growth has left little time for Chinese companies to focus on such fundamental infrastructure of a business. Chasing orders and filling them quickly, coupled with greed and corruption, have been the driving forces for many  “successes”—and blunders—of several manufacturers.  

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].