Clinical Studies in China- Understanding the Regulatory Framework and Trial Process

Release Date
June 07, 2017

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Prior to 2014, medical device manufacturers wishing to introduce products to the Chinese marketplace were able to do so if a subsequent approval was granted by the United States Food & Drug Administration (FDA) or the European Medicines Agency (EMA), per China Food & Drug Administration (CFDA) regulations.

However, beginning in October of 2014, this approval process shifted significantly requiring product manufacturers to conduct local clinical trials to demonstrate products’ effectiveness and safety if no sufficient or existing data existed. Although the updated CFDA regulation has subsisted for nearly three years, the approval process in China can still be challenging to understand and appropriately navigate.

Join NAMSA on June 7, 2017 at 10:00 AM EDT/9:00 AM CDT/7:00 AM PDT/4:00 PM CEST or June 8, 2017 at 10:00 AM China Standard time with clinical expert Amber Fang, Clinical Director, NAMSA China as we discuss medical device registration and clinical trial guidelines under the current CFDA guidance.
Discussion points will include:

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Time for Q&A will also be included.