China’s State Food and Drug Administration (SFDA) issued various medical device GMP regulations in December 2009. These regulations include detailed GMP rules for sterile and implantable medical devices and GMP inspection standards for sterile and implantable medical devices. All of these regulations have been marked as interim and could be subject to change.
SFDA has also issued notices on standardizing the production quality management systems and supervision and inspection of sterile/implantable medical devices.
For non-sterile/implantable medical devices, SFDA has formulated Good Manufacturing Practice for Medical Devices (interim) and Requirements for Medical Device GMP Inspection (interim). These regulations will standardize quality management systems, intensify supervision on manufacturing, and strengthen the management of medical device GMP inspection.
The Good Manufacturing Practice for Medical Devices (interim) is made of 13 chapters, 69 articles and will take effect as of January 1, 2011. The 13 chapters include management responsibilities, files and record requirements, design and development, manufacturing management, inspections, sales and services, adverse events, etc.