The National Medical Products Administration recently released the "Draft Measures for Optimizing Full Life Cycle Supervision to Support the Innovation and Development of High end Medical Devices", which introduces a series of innovation support policies for cutting-edge fields such as medical robots and artificial intelligence medical devices. These new policies will accelerate the breakthrough of high-end medical device technology in China, promote the upgrading of the medical and health industry, and better meet the health needs of the people. The latest policy to be introduced focuses on full lifecycle supervision, proposing ten key measures covering the entire chain of review and approval optimization, standard system construction, and post listing supervision strengthening. Among them, the implementation of the "Innovation Special Review" procedure for domestically pioneering and internationally leading high-end medical devices, and the clarification of registration guidance policies for cutting-edge technologies such as artificial intelligence and brain computer interfaces, has attracted high attention from the industry. In terms of optimizing the approval process, the policy proposes to shift the focus of review to the research and development stage, explore the "conditional approval" mechanism, and simplify the registration requirements for AI product changes optimized by core algorithms. It is understood that the new regulations will significantly shorten the launch cycle of innovative products, especially for the development of artificial intelligence and large-scale medical software, which is a major benefit. In response to the rapidly developing field of medical robots, policies have for the first time clarified classification guidelines and naming conventions, and accelerated the development of industry standards for surgical robots, exoskeleton robots, and other products. It is understood that a unified standard will lay the foundation for domestic high-end equipment to participate in international competition. In terms of quality and safety supervision, the new policy requires full lifecycle monitoring of key products such as surgical robots and high-end imaging equipment, establishing a "regulatory consultation" mechanism, and exploring innovative management models such as electronic instructions for medical devices. The National Medical Products Administration emphasizes the need to support innovation acceleration while also maintaining safety bottom lines. Through proactive monitoring and big data analysis, risks can be detected and intervened early. The reporter noticed that the policy specifically proposes to promote global regulatory coordination and support the development of enterprises' "going global". The National Medical Products Administration stated that it will actively participate in the formulation of international standards, accelerate the transformation and application of international standards, and strengthen the training of domestic regulatory standards. Actively participate in international regulatory organizations such as the International Medical Device Regulatory Forum (IMDRF) and GHWP, as well as international exchanges and cooperation with drug regulatory agencies of countries and regions jointly building the "the Belt and Road". Support high-end medical device enterprises to "go global" development, improve policies related to medical device export sales certificates, and expand the scope of export sales certificate issuance. Relying on international exchange platforms to timely capture the new track of international medical device innovation products, actively promote China's medical device regulatory model and innovative achievements. At present, the policy is publicly soliciting opinions, and the public can submit suggestions through the official website of the National Medical Products Administration. Industry insiders believe that with the implementation of policies, China is expected to achieve leapfrog development in fields such as intelligent diagnosis and treatment, precision medicine, and contribute more "Chinese solutions" to the global healthcare industry. According to data from the Ministry of Industry and Information Technology, the scale of China's high-end medical device market has exceeded 800 billion yuan in 2023, with a compound annual growth rate of 18% in the past five years. The fields supported by this policy, such as medical robots and artificial intelligence assisted diagnosis, are the core areas of global medical technology competition. (New Society)