www.chinaservicesinfo.com

Medical Devices

NMPA issues the Announcement on Medical Device GMP Appendix: Independent Software

Updated: Jul 12, 2019 CCFDIE Print
Share - WeChat

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.

Copyright©2024 China Daily. All rights reserved.

京ICP备13028878号-6

京公网安备 11010502032503号 京公网安备 11010502032503号