Emphasis on institutional construction and improvement of the regulatory system for medical devices

According to the work deployment of the Legal Affairs Office of the State Council, SFDA will continue to promote the revision of the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") this year.
Jiao Hong stated that institutional construction is fundamental to doing a good job and has a global and long-term nature. The revised Regulations will establish and improve a series of systems. We need to actively promote the revision of the "Regulations", improve supporting regulations and normative documents, and the national bureau should prepare a plan for the preparation of medical device regulatory regulations and normative documents. Those in urgent need can be released before the introduction of the "Regulations".
It is reported that in 2012, SFDA actively promoted the revision of the Regulations on the Supervision and Administration of Medical Devices, organized and participated in several special meetings, cooperated with the State Council Legal Affairs Office to summarize and analyze relevant feedback opinions, actively participated in departmental coordination work, and made efforts to promote the revision process of the Regulations. And in accordance with the principles determined in the "Regulations (Third Solicitation Draft of the Legal Affairs Office)", we will promote the preparation and revision of supporting regulations and normative documents such as the "Medical Device Registration Management Measures".
At the same time, we will also strengthen the revision of normative documents and improve the regulatory system. SFDA has issued a notice on the requirements for registration after adjusting the management category of medical devices, a notice on the management of decorative color flat contact lenses according to medical devices, a notice on the re registration of nano silver products, a notice on further clarifying the implementation requirements for customized denture raw materials and product standards, and a medical device flight inspection work procedure The Notice on Standardizing the Management of Comparative Trials by Medical Device Testing Institutions and other normative documents have been organized to formulate regulatory regulations such as the "Regulations on the Registration and Management of in vitro Diagnostic Reagent Packaging", the "Inspection and Evaluation Standards for Medical Device Production Quality Management Standards", the "Interim Provisions on Supervision and Evaluation of Medical Device Testing Institutions", and the "Quality Management Standards for Clinical Trials of Medical Devices (Trial)".
It is also reported that in 2013, SFDA will leverage the resources of the entire system to further revise and improve relevant supporting regulations and normative documents such as the "Medical Device Registration Management Measures". Develop and release normative documents such as the "Special Approval Procedure for Innovative Medical Devices", "Quality Management Standards for Clinical Trials of Medical Devices", and "Inspection and Evaluation Standards for Production Quality Management Standards for Medical Devices (Trial)". Organize the development of the "Management Measures for Qualification Accreditation of Medical Device Clinical Trial Institutions" and the "Catalogue of High Risk Medical Devices in Clinical Trials", as well as the approval procedures for clinical trials, to strengthen the management of high-risk medical device clinical trials.
The reporter learned from the meeting that SFDA will actively promote the reform of the medical device registration review and approval mechanism this year; Continue to strengthen the standardization and classification management of medical equipment; Strengthen the supervision of medical equipment production and operation; Strengthen the supervision and management of medical equipment testing institutions; Promote adverse event monitoring and re evaluation; Implement the 12th Five Year Plan projects effectively; Effectively strengthen the construction of the team and the construction of Party conduct and clean governance.
Jiao Hong emphasized that the central task should be to "ensure safety", comprehensively implement the "12th Five Year Plan", focus on reforming and improving institutional mechanisms, and strive to form a "standardized administrative management, standardized system construction, informationized regulatory services, and a leading country in scientific research"


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