To strengthen production supervision of independent software as medical devices and regulate its quality management, according to the Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 680), and theAdministrative Measures for the Supervision of Medical Device Manufacturing (CFDA Order No. 7), NMPA organized the drafting of and released on July 12, 2019 the Medical Device GMP Appendix: Independent Software.

　　This Appendix features special requirements for independent software medical device GMP. The independent software medical device production quality management system shall comply with the requirements of the Medical Device GMP and this Appendix.