New version of the "Medical Device Supervision and Administration Regulations" announced; the registration system becomes the mainstay of the new regulatory system.   Preventing enterprises from crossing the regulatory red line   Recently, the revised "Medical Device Supervision and Administration Regulations" were announced, and they will officially come into effect on June 1, 2021.   Registration and filing holders should establish and effectively operate a quality management system, strengthen post-marketing management of products, establish and implement product traceability and recall systems, and legally assume responsibility for the safety and efficacy of medical devices throughout the process of research, development, production, operation, and use.   Implement industry and market access restrictions on seriously unlawful enterprises, which will help enterprises to abide by the "red line" of medical device quality and safety, and form a strong deterrent to enterprises that violate regulations, preventing them from gaining a foothold and promoting the healthy and compliant development of enterprises.   Medical devices directly relate to the lives and health of the people. Recently, the revised "Medical Device Supervision and Administration Regulations" (hereinafter referred to as the "Regulations") were announced and will officially come into effect on June 1, 2021.   In recent years, with the rapid development of the medical device industry, the Party Central Committee and the State Council have made a series of major policy decisions on the reform of the drug and medical device evaluation and approval system. In this context, the original "Regulations" have been revised to consolidate the achievements of the reform in the form of regulations, promoting further innovation in the industry and better meeting the expectations of the people for high-quality medical devices.   Industry insiders believe that this revision is a milestone in China's medical device regulatory history and the development of the Chinese medical device industry, which will play an important role in promoting the rapid development of China's medical device industry. Among them, the registration system is a major highlight of the new version of the "Regulations" and is also the mainstay of the new regulatory system.   Strengthening corporate responsibility and establishing a recall system   As of the end of 2020, the number of medical device manufacturing companies in China was about 26,000, including approximately 15,000 companies manufacturing Class I medical devices, 13,000 companies manufacturing Class II medical devices, and 2,000 companies manufacturing Class III medical devices. The total number of enterprises registered and filed for medical devices is 890,000. The scale of domestic medical device production and sales in China has been growing at an annual rate of about 20%, while the global growth rate is 5% to 6%. The market size of domestic medical devices has greatly exceeded the global growth rate.   In recent years, with the coordinated efforts of various national regulatory policies, domestic medical devices have seen robust development in many categories, achieving import substitution. However, problems cannot be ignored, and domestic medical device manufacturing companies are currently facing fragmentation and a pressing need to improve innovation capabilities.   To address this, the "Regulations" focus on implementing the registration system for medical device registration holders and filing holders to strengthen corporate responsibility. The "Regulations" stipulate that registration and filing holders should establish and effectively operate a quality management system, strengthen post-marketing management of products, establish and implement product traceability and recall systems, and legally assume responsibility for the safety and efficacy of medical devices throughout the process of research, development, production, operation, and use.   Yu Qingming, Secretary of the Party Committee of China National Pharmaceutical Group Corporation and a representative of the 13th National People's Congress, pointed out that the registration holder system (holder registration system) is a commonly used management system