国家药品监督管理局发布《关于医疗器械生产质量管理规范附录独立软件的通告》
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为加强独立软件类医疗器械生产监管，规范独立软件生产质量管理，根据《医疗器械监督管理条例》（国务院令680号）、《医疗器械生产监督管理办法》（国家食品药品监督管理总局令第7号），国家药品监督管理局组织起草了《医疗器械生产质量管理规范附录独立软件》，于7月12日发布。
本附录是独立软件医疗器械生产质量管理规范的特殊要求。独立软件类医疗器械生产质量管理体系应当符合《医疗器械生产质量管理规范》及本附录的要求。
(-07-12)
NMPA Issued the Announcement on Medical Device GMP Appendix: Independent Software
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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 the Administrative Measures for the Supervision of Medical Device Manufacturing (CFDA Order No. 7), NMPA organized the drafting of and released on July 12, 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.
(July 12, )
国家药品监督管理局英文网站上线
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7月18日，国家药品监督管理局英文网站正式上线，这是国家药品监督管理局组建后，全面推进药品监管信息公开、加强公众交流的又一重要举措。目前，英文版网站设置了机构简介、新闻动态、法规文件、监管信息、政策解读、科普信息、药品、医疗器械、化妆品等栏目，基本与中文网站栏目保持一致，今后将努力实现中英文信息同步更新，及时将中国药品、医疗器械、化妆品监管声音传递到世界。
(-07-19)
Debut of NMPA English Website
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On July 18, the English website of NMPA was officially launched, marking another important measure for comprehensive promotion of drug regulatory information disclosure and public communication in the wake of the establishment of NMPA. At present, the English-version website has set up About NMPA, News, Laws & Regulations, Regulatory Information, Policies Interpretation, Popular Science, Drugs, Medical Devices, Cosmetics and other Columns that are basically in line with those of the Chinese website. NMPA will strive to achieve synchronous update of Chinese and English information henceforth, to timely transmit the information of China"s supervision over drugs, medical devices and cosmetics to the world.
(July 19, )
