China to Eliminate Redundant Testing and Certification for Medical Devices

The Chinese government has agreed to take action to eliminate redundancy in testing and certification for medical devices imported into China. China agreed that it would eliminate all duplicative testing and certification requirements for medical devices by the end of May 2006. This pledge was made during the April meeting of the U.S.-China Joint Commission on Commerce and Trade (JCCT). The U.S. government has argued that these duplicative requirements served as a trade barrier, restricting foreign companies’ access to China’s medical device market.

The Chinese government’s efforts are a positive development for the U.S. medical device industry, which has maintained that the requirements are time-consuming and do not improve the safety of devices. It is hoped that the Chinese government’s reevaluation of these duplicative requirements will lead to a more streamlined product registration process for medical devices.