The         National Medical Products Administration (NMPA) recently issued the "Response to Proposal No. 5388 of the Third Session of the 14th National People's Congress," detailing national support policies and development directions for innovative medical devices, boosting industry confidence. The response outlines specific measures to enhance China's medical device innovation capability and accelerate the market launch of domestic innovative products.

        In review and approval mechanism reforms, NMPA has achieved remarkable results. Early this year, the review time for clinical trials of innovative pharmaceuticals and medical devices was shortened from 60 working days to 30 working days, improving efficiency by 50%. A special review procedure for innovative medical devices was established, creating a green channel for products with obvious clinical advantages. Data show 45 innovative medical devices were approved in the first half of this year, a year-on-year increase of 87.5%, a record high.

        The response emphasizes several aspects: strengthening clinical trial supervision for data authenticity and reliability; fully utilizing clinical experts in reviews, with a consultation team of over 500 experts from various fields; implementing charging policies for new technologies to ensure reasonable pricing and medical insurance payment for innovative products; and promoting high-quality development of the medical equipment industry, supporting breakthroughs in key core technologies.

        In promoting clinical application of innovative products, the Medical Insurance Administration explicitly requires medical institutions at all levels not to restrict innovative medical device admission for reasons like drug and consumable proportion. An innovative product catalog will be established, implementing "should be equipped as needed," opening a fast track for innovative products to enter clinical practice. Medical insurance payment policies will be improved, providing appropriate payment standards for innovative products with real clinical value to ensure patient accessibility.

        Regulatory authorities also emphasized support for small and medium-sized innovative enterprises. Through early intervention and whole-process guidance, they will help them solve technical problems during R&D and registration. Regional innovation service stations will be established to provide face-to-face technical guidance and policy consultation, reducing innovation costs and shortening the R&D cycle.

        In international development, NMPA will actively promote international mutual recognition, align Chinese standards with international standards, and support domestic innovative medical devices in entering the global market. Currently, several domestic innovative products have obtained US FDA and EU CE certification, with improving international competitiveness.

        Industry experts believe these policies will greatly stimulate medical device innovation vitality. Innovative medical device approvals are expected to maintain over 30% annual growth in the next three years, with breakthroughs in high-end imaging equipment, surgical robots, new interventional products, etc. Policy dividends will promote synergistic development across the industry chain, forming a good innovation ecosystem.

        The industry responded enthusiastically. Heads of several medical device companies said clear policy direction and continuous institutional innovation have increased their R&D investment confidence. Industry R&D investment intensity has risen from 3.5% five years ago to 6.8%, near international advanced levels. As policies take further effect, China's medical device industry is expected to occupy a more important global innovation position.