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【CODEX】2014 No. 64 国家食品药品监督管理总局关于发布医疗器械生产质量管理规范的公告

关于发布医疗器械生产质量管理规范的公告

Notice on Good Manufacturing Practice for Medical Devices

 

为加强医疗器械生产监督管理,规范医疗器械生产质量管理,根据《医疗器械监督管理条例》 (国务院令第650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), 国家食品药品监督管理总局组织修订了《医疗器械生产质量管理规范》,现予以发布。

In order to strengthen the supervision and management of medical device manufacturing and standardize the quality management of medical device manufacturing, according to Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650) and Provisions for the Supervision of Medical Device Manufacturing (CFDA Order No. 7), CFDA has formulated Notice on Good Manufacturing Practice for Medical Devices and now issues it.

 

特此公告。

It is hereby promulgated.

 

附件:医疗器械生产质量管理规范

Annex: Good Manufacturing Practice for Medical Devices

食品药品监管总局

2014年12月29日

 

医疗器械生产质量管理规范

Good Manufacturing Practice for Medical Devices


第一章 总 则

Chapter I General Provisions

 

  第一条 为保障医疗器械安全、有效,规范医疗器械生产质量管理,根据《医疗器械监督管理条例》(国务院令第650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),制定本规范。

Article 1. In order to guarantee the safety and effectiveness of medical device and standardize the quality management of medical device manufacturing, according to Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650) and Provisions for the Supervision of Medical Device Manufacturing (CFDA Order No. 7), CFDA has formulated the GMP for medical device.


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