In accordance with the work plan of the Legislative Affairs Office of the State Council, the SFDA will continue this year to advance the revision of the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the “Regulations”).

　　Jiao Hong stated that institutional development is fundamental to effective work and is both comprehensive and long-term. The draft Regulations currently under revision will establish and refine a series of systems. We must actively advance the revision process, improve supporting rules and normative documents, and ensure that the National Medical Products Administration formulates a clear plan for drafting regulatory and normative instruments on medical device oversight; those urgently needed may be promulgated prior to the official issuance of the Regulations.

　　It is reported that in 2012, the SFDA actively promoted the revision of the Regulations on the Supervision and Administration of Medical Devices, organizing and participating in numerous specialized meetings, coordinating with the Legislative Affairs Office of the State Council to collate and analyze relevant feedback, and engaging proactively in inter‑departmental coordination efforts to advance the revision process. Furthermore, in accordance with the principles set forth in the Regulations (the Legislative Affairs Office’s third draft for public comment), it advanced the formulation and amendment of supporting rules and normative documents, including the Measures for the Registration of Medical Devices.

　　At the same time, efforts to formulate and revise normative documents have been strengthened to further improve the regulatory framework. The SFDA has issued a series of normative documents, including the “Notice on Requirements for Registration-related Work Following Adjustments to the Classification of Medical Devices,” the “Announcement on the Regulation of Decorative Colored Plain Contact Lenses as Medical Devices,” the “Notice on Matters Relating to the Re‑registration of Nanosilver Products,” the “Notice on Further Clarifying Implementation Requirements for Raw Materials and Product Standards of Custom‑Made Dentures,” the “Procedures for Spot Inspections of Medical Devices,” and the “Notice on Standardizing the Management of Proficiency Testing by Medical Device Testing Institutions.” In addition, it has organized the development of regulatory provisions such as the “Regulations on the Registration and Management of Repackaging of In Vitro Diagnostic Reagents,” the “Inspection and Evaluation Criteria for Good Manufacturing Practice of Medical Devices,” the “Interim Provisions on Supervisory Reviews of Medical Device Testing Institutions,” and the “Good Clinical Practice for Medical Device Clinical Trials (Trial).”

　　Additionally, it was reported that in 2013, the SFDA will leverage resources across the entire regulatory system to further revise and refine the Measures for the Registration of Medical Devices and other related supporting regulations and normative documents. It will formulate and issue such normative documents as the Special Approval Procedure for Innovative Medical Devices, the Good Clinical Practice for Medical Device Clinical Trials, and the Inspection and Evaluation Standards for the Good Manufacturing Practice for Medical Devices (Trial). Furthermore, it will organize the development of the Measures for the Accreditation of Clinical Trial Institutions for Medical Devices, the Catalogue of High-Risk Medical Devices Subject to Clinical Trials, and the procedures for clinical trial approval, thereby strengthening the oversight of clinical trials involving high-risk medical devices.

　　At the conference, reporters learned that this year the SFDA will continue to vigorously advance reforms of the medical device registration, review, and approval system; further strengthen work on medical device standards and classification; intensify oversight of the production and marketing of medical devices; enhance supervision and management of medical device testing institutions; promote adverse event monitoring and re‑evaluation; ensure the effective implementation of projects under the 12th Five-Year Plan; and earnestly bolster personnel development and efforts to uphold integrity and clean governance.

　　Jiao Hong emphasized that the central task must be “ensuring safety,” with full implementation of the 12th Five-Year Plan, concerted efforts to reform and improve institutional mechanisms, and a determined drive to establish a regulatory framework characterized by “standardized administrative management, standardized system development, information‑based supervision and services, and internationally oriented scientific research.” She also called for strengthening the workforce and fostering integrity and clean governance, so as to elevate medical device regulation to a new level.