ABSTRACT
China’s initial attempt to regulate medical devices was characterized by a good deal of overlap and competition for preeminence between agencies of the central government. The current system rationalized some of the responsibilities although overlapping requirements and redundant testing for some medical devices by different agencies remains. The framework for medical device regulation in China was established by an order of the State Council of the PRC. The Regulation on Supervision and Administration of Medical Devices (China MDR) was adopted in council on December 18, 1999, and became effective on April 1, 2000.
