The State Food and Drug Administration recently issued the "Measures on Optimizing the Full Life Cycle Supervision to Support the Innovative Development of High-end Medical Devices (Draft for Comments)", and launched a series of innovative support policies for cutting-edge fields such as medical robots and artificial intelligence medical devices. These new policies will accelerate breakthroughs in my country's high-end medical device technology, promote the upgrading of the medical and health industry, and better meet the health needs of the people.

The latest policies proposed to be issued focus on full life cycle supervision and propose ten key measures to cover the entire chain of review and approval optimization, standard system construction, and post-market supervision strengthening.

One of which, the "Special Review of Innovation" procedure is implemented for domestically pioneering and internationally leading high-end medical devices, and the registration guidance policies for cutting-edge technologies such as artificial intelligence and brain-computer interfaces have been clarified, which has attracted great attention from the industry.

In terms of optimization of the approval process, the policy proposes to move the focus of review forward to the R&D stage, explore the "conditional approval" mechanism, and simplify the registration requirements for the core algorithm optimization of artificial intelligence products. It is understood that the new regulations will significantly shorten the market cycle of innovative products, especially for the development of artificial intelligence and large-model medical software.

In view of the current rapidly developing medical robot field, the policy has clarified classification guidelines and naming specifications for the first time, and accelerated the formulation of industry standards for products such as surgical robots and exoskeleton robots. It is understood that unified standards 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 the implementation of full-life cycle monitoring of key products such as surgical robots and high-end imaging equipment, establish a "regulatory consultation" mechanism, and explore innovative management models such as electronic instructions for medical devices. The State Food and Drug Administration emphasized that it is necessary to support the acceleration of innovation, but also to maintain the bottom line of safety and achieve early risk detection and early intervention through active monitoring and big data analysis.

The reporter noticed that the policy specifically proposed to promote global regulatory coordination and support enterprises to "go overseas" development. The State Food and Drug 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 regulations and standards. Actively participate in international exchanges and cooperation between international regulatory organizations such as the International Medical Device Regulatory Agency Forum (IMDRF), GHWP, and countries and regions in jointly building the "Belt and Road" policy. Support high-end medical device companies to "go overseas" to develop, improve relevant policies on export sales certificates for medical devices, and broaden the scope of issuance of export sales certificates. Relying on the international exchange platform, we will promptly capture the new track of innovative international medical device products and actively publicize China's medical device supervision model and innovative achievements.

The policy is currently being solicited for public comments, and the public can submit suggestions through the official website of the State Food and Drug Administration. Industry insiders believe that with the implementation of the policy, my country is expected to achieve leapfrog development in the fields of intelligent diagnosis and treatment, precision medicine, and contribute more "Chinese solutions" to the global medical and health industry.

According to data from the Ministry of Industry and Information Technology, the market size of my country's high-end medical device has exceeded 800 billion yuan in 2023, with a compound growth rate of 18% in the past five years. The tracks such as medical robots and artificial intelligence-assisted diagnosis supported by this policy are the core areas of current global medical technology competition.

(CCTV reporter Zhang Yun)