Announcement on the “Supplementary Appendix of Medical Device Manufacturing Quality Management for Stand-alone Software” (2019 No. 43)

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

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