China's medical device regulations have evolved greatly over the past twenty years. However, navigating the Chinese regulatory system is still a daunting task for many western companies. This audio conference provides essential information on the Chinese regulatory requirements for medical devices. Our speaker provides attendees with first-hand insight and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China. Attendees learn the essential requirements for getting their medical products approved for the Chinese market, the time and costs involved, issues to watch for and obstacles down the road.

This audio conference covers:

• Overview of Chinese regulations for medical devices
• Recent changes to the regulatory requirements
• Requirements for getting medical products approved for the Chinese market
• Time and costs for getting regulatory approval of medical products in China
• Regulatory issues to watch for and obstacles while seeking approval in China

About the speaker:

Chang-Hong Whitney, MBA, RAChas been in the medical device industries in both China and the US for over 30 years. She began to consult for international medical companies and regulatory affairs in 1994, and has presented on China-related issues at various industry and professional conferences. Mrs. Whitney also hosted the China Column in Medical Product Outsourcing Magazine and Regulatory Affairs Journal.

Mrs. Whitney holds an MBA from Babson College, as well as undergraduate degrees in electrical engineering and international business. She is a member of Regulatory Affairs Professional Society (RAPS) and an active member of other committees for regulatory affairs. She is on the Healthcare Council of Gerson Lehrman Group, providing assessment to financial institutions interested in the Chinese medical market. Her company, Whitney Consulting is exclusively focused on China regulatory affairs for medical devices, and operates from offices in Beijing and Boston.

Who should attend?

• Regulatory Affairs
• Marketing
• Sales and Business Development
• International business managers
• Quality managers or specialists
• Senior management