The National Medical Products Administration ("NMPA") has recently issued the Appendix on Standalone Software to the Good Manufacturing Practice for Medical Devices (the "Appendix"), with effect from July 1, 2020.
The Appendix applies to standalone software and may be used as reference for software components. The Appendix makes clear its role as special requirements for standalone software supplementary to the good manufacturing practice, and touches upon personnel, equipment, design and development, procurement, production management, quality control, sales and after-sales services, and monitoring and analysis of adverse events and improvement. The Appendix highlights that personnel engaged in development, testing and maintenance of software shall have the specialized knowledge, practical experience and work capacity that are indispensable to perform their job responsibilities; in black-box testing, developers of a software program shall not be this program's testers; clients' testers shall have proper experience in operation of software products, or gain the proper skills to operate the software product after receiving training; and the cloud computing service agreement should clearly specify which party shall bear the liability for ensuring cybersecurity and protection of data and privacy of patients.