China NMPA officially released a “Supplementary Appendix of Medical Device Manufacturing Quality Management for Stand-alone Software“ to tighten the manufacturing supervision of individual software-typed medical device and standardize the GMP manufacturing quality management of stand-alone software. 

Get in touch with us at global@osmundacn.com to get the full, translated version of the document and receive consultation on the medical device strategic entry of China market. 

Published on July 5, 2019