The newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") came into effect on June 1, 2014. In order to cooperate with the implementation of the "Regulations", on the basis of in-depth research, repeated demonstrations, and extensive solicitation of opinions from all parties, the State Food and Drug Administration has formulated and revised the "Administrative Measures for the Registration of Medical Devices" and "Administrative Measures for the Registration of In Vitro Diagnostic Reagents". , "Medical Device Instructions and Labeling Management Regulations", "Medical Device Production Supervision and Management Measures", "Medical Device Operation Supervision and Management Measures" and other five regulations. The five regulations have been deliberated and approved at the executive meeting of the General Administration on June 27, and were promulgated on July 30 with orders No. 4, 5, 6, 7, and 8 of the General Administration, and will be implemented on October 1, 2014.
The newly formulated and revised five rules implement the spirit of the Party Central Committee and the State Council on establishing the most stringent food and drug supervision system covering the whole process, accelerating the transformation of government functions and deepening the reform of the administrative approval system, and insisting on risk management, whole-process management, social governance, and responsibility. Governance, efficiency governance and other concepts, encourage innovation, highlight corporate responsibility, strengthen the supervision of research, production, operation and other links, through the refinement of the relevant provisions of the "Regulations", so that the overall design of the "Regulations" for the medical device supervision system is truly "" landing".
The five regulations scientifically set the approval and filing system according to the risk level of medical device products, specify the conditions, procedures and time limits for product registration (filing) and enterprise production and business licenses, and clarify the main obligations and responsibilities of enterprises. The requirements for instructions and labels have been refined, the means and measures of supervision and inspection by regulatory authorities have been strengthened, and legal responsibilities have been tightened. It has provided clear guidelines for medical device registration (filing) and production and operation, and has provided strong support for strengthening medical device supervision and governance. support.
The promulgation of the five regulations is of great significance to improve the medical device regulatory system, standardize the medical device market order, promote the healthy development of the medical device industry, ensure the safety and effectiveness of medical devices, and protect human health and life safety. In the next step, the General Administration will actively carry out the interpretation of the five regulations and related publicity and training work to lay a good foundation for the implementation of the regulations.
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