【CODEX】医疗器械经营监督管理办法（1-2）-EN
医疗器械经营监督管理办法
Provisions for the Supervision of Medical Device Distributing
2017年11月21日 发布
Issued on November 21, 2017
医疗器械经营监督管理办法
（2014年7月30日国家食品药品监督管理总局令第8号公布 根据2017年11月7日国家食品药品监督管理总局局务会议《关于修改部分规章的决定》修正）
(China Food and Drug Administration order, No. 8 was issued on July 30, 2014 and was amended according to the Decision on Amending Some Rules and Regulations of the executive meeting of China Food and Drug Administration on November 7, 2017)
第一章 总 则
Chapter I General Provisions
第一条 为加强医疗器械经营监督管理，规范医疗器械经营行为，保证医疗器械安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1.In order to strengthen the supervision and administration of medical device distributing, standardize the distributing of medical device and ensure the safety and effectiveness of medical device, according to Regulations for the Supervision and Administration of Medical Device, CFDA has formulated the Provisions.
