China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.

This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.

This audio conference covers:

• How China is enforcing medical device GMPs
• Monitoring medical device adverse events in China
• Exemption of clinical trial data for Class II devices
• Managing medical device recalls
• China's progress in moving towards a global standard

About the speaker:

Seth J. Goldenberg Ph.D. is a former regulatory chemist with the FDA and is currently president of APBI, which focuses on helping U.S. companies through the cultural and regulatory challenges of bringing pharmaceutical, biotech, and medical device products to China. He holds a PhD in Pharmacology from the University of Washington and an MS from the School of Biomedical Engineering at Drexel University. He has a strong record in drug development, FDA, business development, product licensing, grant writing, scientific patents, medical communications, and collaborations with academia and industry. Dr Goldenberg understands not only what it takes to carry out scientific study, but also the importance of communicating it with the global scientific community to foster partnerships and collaboration.

Who should attend?

• Regulatory Affairs
• Quality
• Business Development
• Senior Executives