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Audio conference highlights

With over 1.4 billion people and an emerging public healthcare system, China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving. In this audio conference, our speaker discusses the background of SFDA regulatory requirements and explain the process of registering your product in China, including specific information on how the SFDA defines and classifies a medical device, the registration dossier required by SFDA, regulatory criteria for testing and clinical trials. The presentation also provides examples of what has helped companies succeed in achieving approvals, and discuss the latest trends in the China regulatory environment.

This audio conference covers:

• An overview of China's regulatory system
• How to register your product in China
• Lessons learned and successful strategies for gaining approval
• Recent trends in the Chinese regulatory environment

About the speaker:

Janice Ma is the Operations Director and Co-founder of ChinaGate Ltd., a leading pharmaceutical, medical device and IVD consulting company. She has extensive experience in project management, regulatory affairs, patents and trademark registration in the pharmaceutical and medical device sectors in China.

Prior to co-founding ChinaGate, Ms. Ma worked with two of the top 10 multinational pharmaceutical companies as Regulatory Manager and Project Manager, achieving success on development of numerous ethical drugs, biological products and OTC drugs in China.

Since co-founding ChinaGate in 2002, Ms. Ma has led the team to successfully obtaining more than 50 import medical device registration licenses. She has also successfully helped Chinese medical device manufacturers obtain several USA FDA 510k approvals. She has cross-experiences and is familiar with regulatory requirements and regulations of China SFDA, USA FDA and European CE approval.

Who should attend?

• Regulatory Affairs Engineer/Manager/Director
• International Marketing Manager/Director
• Quality Engineer/Manager/Director
• Senior Management
• Clinical Affairs Manager
• Procurement Manager
• Legal Affairs

This audio conference is rated General Interest.