China to Relax Regulatory Process for Foreign Device Companies
BY LAUREN UZDIENSKI, NOVEMBER 3, 2009
Last week's Joint Commission on Commerce and Trade meeting between the U.S. and China in Hangzhou resulted in a number of changes to China's regulatory process, which has historically been costly and time-consuming for foreign 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.
China may also ease its rules about local product testing. The SFDA may exempt a company from required testing in a local Chinese lab if they demonstrate compliance with international standards and present data from testing outside China.
Finally, China has agreed that marketing clearance from any foreign country will satisfy their requirement for prior registration. In the past, a device was required to have been cleared by its home country.
In a statement, AdvaMed praised the Chinese government for the changes, which they said will "provide the Chinese people with access to the most innovative and advanced medical technologies in a timely manner." China has been a focal point in the marketing strategy for several orthopedic companies over the past few years, including Medtronic, who has a joint venture with the Shandong Weigao Group, and Smith & Nephew, who last year expanded their Chinese manufacturing facilities.
