Voices of the two sessions: Accelerating the entry of innovative medical devices into the market

"Innovation is the foundation of a country's foundation and a source of industrial development. China's high-end medical equipment is basically dependent on imports. Whether it can promote the development of innovative medical device products is related to the long-term development of China's medical device industry." Focus on how to promote the development of independent innovation medical device products.

To promote the development of independent innovation medical device products, we must first understand the main problems in the current development. Commissioner Zhao Jiguang said that nowadays, there are many medical devices, each of which has its own technical characteristics and is a cross-disciplinary combination of multidisciplinary technologies, which requires close cooperation between different innovation entities.

"Now there is a lack of mechanism to establish multi-agent collaborative innovation cooperation." Mr. Zhao Jiguang said that some developed countries have a relatively complete interest chain mechanism in the innovation environment, which promotes the mutual transformation between R&D and production entities in the relevant industrial chain. There is a clear distribution mechanism on issues such as profit distribution and intellectual property rights. However, China currently relies on imitation in the direction of innovation in medical devices. "We should change the relevant policy environment by establishing institutional mechanisms for independent innovation, so that independent innovation products have sufficient benefits to return, and solve the problem of insufficient innovation and innovation."

Zhao Jiguang also pointed out that the current industrialization of medical devices needs to be further improved. “The core components of medical devices are not willing to do because of small batch size and small dosage. In the medical device industry innovation, many experts believe that core components are the key issue, but the biggest difficulty in solving the core components problem is insufficient funds. ”

“At the same time, with the rapid development of China's economy and the gradual emergence of innovative medical device products, the contradiction between the policy environment required for innovative medical device products and the existing policy environment has become increasingly prominent.” Talking about the current market environment When questioning, Zhao Jiguang believes that because the hospital's circulation channels are not transparent enough, the degree of marketization is not high, and there is a lack of scientific and standardized professional evaluation of medical device products. "Although China has independently innovated a batch of high-quality domestic medical device products, However, many medical institutions are still 'unwilling to buy, not willing to use', innovative products are difficult to enter the market, high-quality products are not high-quality, and the subsequent development through market returns has become another major problem that restricts the overall development of China's medical device industry. ."

In response to the promotion of the development of independent innovation medical device products, Mr. Zhao Jiguang suggested that the research and development of innovative medical device products be listed as a major special item of the State Council. “New drug research and development has been listed as a major special item of the State Council five years ago, which has greatly promoted the development of the pharmaceutical industry. The development of medical devices in the world is faster than drugs. If the research and development of innovative medical device products is listed as a major special item of the State Council, it will definitely promote The rapid development of China's medical device industry may even soon have a place in the international arena."

Commissioner Zhao Jiguang called on all relevant departments to introduce and implement policies to promote the development of independent innovative medical device products within their respective functions and responsibilities. “Now the State Food and Drug Administration has introduced the “Innovative Medical Device Special Approval Process”. I believe that in the implementation of this procedure, efforts should be made to make innovative medical device products enter the market safely, effectively and quickly.”

Zhao Jiguang members hope that relevant departments can formulate corresponding policies and regulations on price, bidding and hospital access, and promote the rapid entry of innovative medical devices into the domestic market. “It is best to establish a filing system that allows innovative products to enjoy the most favorable access.” Commissioner Zhao Jiguang said: “In the application phase of the product, a similar green channel should also be established. In public hospitals, the state financial support, with fiscal and taxation The means of policy regulation and control enable innovative products to be put into use smoothly, and special policies and reimbursement standards can be encouraged in the medical insurance and other aspects."

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