Decree of State Food and Drug Administration No. 16 Aug.9, 2004 Page 1 / 36 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 medical devices whose registration fails to be approved shall not be sold or used. Article 3 Medical device registration means the process of systematic evaluation of the safety and effectiveness of the medical devices to be sold and used in accordance with the legal procedures to decide whether the sale and use of such medical devices can be approved. Article 4 China implements classified registration and administration of medical devices. Category I domestic medical devices are subject to examination by municipal level (food) drug administration authorities of the administrative areas with districts, and medical device registration certificates will be issued after approval by such authorities. Category II domestic medical devices are subject to examination by the (food) drug administration ...
