China to Relax Regulatory Process for Foreign Device Companies
In the past, the Chinese State Food and Drug Administration (SFDA) required that a study submitted with a marketing application be conducted on a Chinese population. Now China will shift to a risk-based approach on whether to require a local study. Additionally, the SFDA may allow results from a study conducted elsewhere in the world to exempt a company from completing a local trial. This change can potentially save U.S. companies hundreds of millions of dollars.