Medical Devices Regulatory Framework & Update: China (August 2021)

43 pages. The Chinese medical device market and regulatory framework have undergone a myriad of changes in the past few years. Since 2013, the National Medical Products Administration (NMPA), previously known as the China Food and Drug Administration (CFDA) has been revising guidance documents to aid medical device manufacturers with the process of applying for approval in that country. The NMPA is the institution responsible for pharmaceuticals and medical devices regulations across China. For medical device manufacturers, understanding these new standards and the revised regulations is essential. Medical device manufacturers should be aware of the significant impact these changes will have on the global medical device market. It should be noted that although the new regulations and guidance documents provide more structure to the application process in China, the process for gaining access to the market can be a lengthy and complex one. Navigating the process can be intimidating and requires planning with experienced regulators.