SFDA Regulatios

 

Issued Date English Title Chinese Title
2000-04-05 Provisions on the Classification of Medial Device 医疗器械分类规则
2000-05-22 Medical Device Manufacturing Enterprise Quality System Inspection System Method 医疗器械质量体系考核办法
2001-03-14 Provision of Implementation on the Inspection of Quality System of the Oversea Medical Device Manufacturing Enterprises 境外医疗器械生产企业质量体系审查实施规定
2001-03-14 Provision on the Registration and Inspection of Imported Medical Device and Apparatus 进口医疗器械注册检测规定

2002-01-04

Provision of Administration of Medical Device Product Standard (trial)

(please contact us for English version) 		医疗器械标准管理办法（试行）
2002-07-24

Notification of some supplements for Imported and Domestic Class III Medical Device SFDA registration

(please contact us for English version) 		关于进口医疗器械、境内第三类医疗器械注册若干补充说明的通知
2003-01-14

Provisions on Daily Supervision and control for Medical Device Manufacturing

(Trial)

(please contact us for English version)

医疗器械生产企业日常监督调度管理规定（试行）