The newly revised "Regulations for the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") have been implemented since June 1, 2014. In order to cooperate with the implementation of the "Regulations", on the basis of in-depth research, multiple demonstrations, and extensive consultation of all parties, the State Food and Drug Administration has revised the "Administrative Measures for the Registration of Medical Devices" and "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" , "Medical Device Specification and Label 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 reviewed and approved by the General Administration of the State Council on June 27, and announced on July 30 by General Administration Order Nos. 4, 5, 6, 7 and 8, respectively, and will be implemented on October 1, 2014.
The newly revised five regulations implement the spirit of the Party Central Committee and the State Council on establishing the strictest 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 adhere to risk governance, overall governance, social governance, and responsibility Governance, efficiency governance and other concepts, encourage innovation, highlight corporate responsibility, strengthen the supervision of development, production, and management. Through the refinement of the relevant provisions of the "Regulations", 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 in accordance with the level of risk of medical device products, which specifies the product registration (recording) and the conditions, procedures, and time limits for the production and business license of the enterprise, and defines the main obligations and responsibilities of the enterprise. The requirements of instructions and labels have been refined, the means and measures of supervision and inspection by the regulatory authorities have been strengthened, legal responsibilities have been tightened, and clear guidelines have been provided for medical device registration (recording) and production and operation, which has provided a powerful force for strengthening the supervision and governance of medical devices support.
The promulgation of the five regulations is of great significance for improving the regulatory system of medical devices, regulating the order of the medical device market, promoting the healthy development of the medical device industry, ensuring the safety and effectiveness of medical devices, and protecting 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, laying a good foundation for the implementation of the regulations.