China’s State Food and Drug Administration (SFDA) officially inaugurated its Management Center for Medical Device Standards on March 30, 2010. The inauguration was held in the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP). SFDA’s Deputy Commissioner, Zhang Jingli, attended the opening ceremony and delivered speeches.
The main functions of this new Center include committing to develop related standards for medical devices, organizing relevant medical device standardization technical committees to promote and carry out standards in manufacturing, and develop standards for instruments. Other plans include possible improvements to medical device naming, classification, and coding.
Zhang noted the significance of this development, where this Center would standardize medical equipment development, production, management, and supervision to ensure compliance. SFDA will greatly encourage the improvement and innovation of medical device standards, establish and improve the standards system, promote the development of China’s medical device industry and provide more support to the supervision of medical devices to ensure the safety and effectiveness of medical devices for the public.
Thus far, China has issued 180 national standards and 727 industrial standards for medical devices. They have also established 22 medical device standardization technical committees to offer technical support.