GLOBAL PERSPECTIVES
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Ames Gross
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The regulatory environment for medical devices in China is changing rapidly. The State Food and Drug Administration (SFDA) is attempting to bring device regulation up to international standards , so there are frequent changes. Needless to say, if you are doing business in China, it's vital to stay informed.
Previously, China Compulsory Certification testing (CCC) , a government quality marking required for certain medical devices , was often redundant with SFDA's test ing for product registration. In the fall of 2008, t he General Administration of Quality Supervision, Inspection and Quarantin e, which administers the CCC program, and SFDA jointly announced they were unifying testing requirements for the affected medical devices. With the government's new "one test, one fee" policy, the same test will be valid for both types of product registration. It is hoped that this change will reduce the time and money required to bring these medical devices onto the Chinese market.
Another update involves a December 2008 regulation that increases adverse event reporting responsibility for medical device manufacturers selling products in China. Under the new rule, if a manufacturer learns of a fatal medical device adverse event in China, they must report it to the government within five working days. Serious adverse events must be reported within 15 working days. Manufacturers also must report to the government their reevaluations of products based on adverse events, and any changes made in response. Previously, adverse event reporting was not mandatory for medical device manufacturers.
Industry should be on the alert for a number of other significant regulatory changes in 2009. These include a new review procedure for combination drug-device products, an overhaul of the key Provisions for Medical Device Registration, and new Good Clinical Practices (GCP) for medical devices.
Ames Gross, president and founder of Pacific Bridge Medical (PBM), is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, MD&DI (Medical Device and Diagnostic Industry) magazine named Gross one of the top 100 executives in the medical business. Gross founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. He is a frequent contributor of articles on Asian medical issues for Clinica (UK), MD&DI (Los Angeles), and other medically oriented journals. Gross has been a featured speaker on the Asian medical markets at the Medical Design & Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society's annual and regional meetings, and a variety of other medically oriented meetings and conferences. Gross holds a BA, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University. For more information about PBM, view its listing in the online Consultants Directory or go to the firm's Web site at www.pacificbridgemedical.com.
