文档介绍：医疗器械注册管理办法英文版
The Measures for the Administration of Medical Device Registration were passed by State Food and Drugficates will be issued after approval by such authorities.
Category III domestic medical devices are subject to examination by the State Food and Drug Administration (SFDA), and medical device registration certificates will be
The Measures for the Administration of Medical Device Registration were passed by State Food and Drug Administration at the administration affairs meeting on May 28, 2004 and are hereby promulgated for implementation as of the date of promulgation.
Director general: Zheng Xiaoyu
Aug. 9, 2004
Measures for the Administration of Medical Device Registration
Chapter 1. General Provisions
Article 1
These Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices to standardize the administration of medical device registration and guarantee the safety and effectiveness of medical devices.
Article 2
All the medical devices sold and used within the territory of the People’s Republic of China shall be subject to application for registration in accordance with the provisions of these Measures. The