Reposted from: Chinese medicine Report  

country National Medical Products Administration   Medical device   Registration Management Department Director Lü Ling

The CPC Central Committee and the State Council have set forth clear requirements for the high-quality development of the medical device sector. The National Medical Products Administration has implemented a range of measures to support innovation and development in the industry, with a new regulatory framework largely taking shape. Policies encouraging industrial innovation continue to gain momentum, leading to the steady emergence of key innovative products and the ongoing refinement of review and approval procedures.

To support innovation in medical devices, the National Medical Products Administration has organized the revision of the Regulations on the Supervision and Administration of Medical Devices, fully implementing the medical device registration holder system, through… Innovative Healthcare The special review procedure for medical devices and the priority review procedure for medical devices have established “green channels” for relevant products, while continuously refining review and approval systems and mechanisms—such as clinical evaluation and conditional approval—and optimizing requirements for product market access. At the same time, a pre‑review mechanism has been put in place, shifting the focus of review earlier to the product development stage; moreover, the National Medical Products Administration’s Yangtze River Delta and Greater Bay Area Technical Review and Inspection Centers, along with nine innovation service stations, are being leveraged to strengthen communication and guidance for innovative products.

Policy incentives that foster innovation continue to be rolled out. Since 2014, the National Medical Products Administration has approved the market launch of 237 innovative medical devices, including 215 domestically produced products and 22 imported ones.

Innovation requires not only policy and institutional support but also robust technological underpinnings. To this end, the National Medical Products Administration (NMPA) has continuously strengthened the foundational work of medical device registration management, advanced the development of medical device standards and classification systems, and vigorously promoted smart regulation and regulatory science. In terms of standardization, the existing national and industry standards for medical devices now broadly cover all technical sub‑fields in China, with a conformity rate to international standards approaching 90%; the coverage, systematic nature, and international harmonization of the standards framework are steadily improving. On the front of information technology, the NMPA has been advancing the establishment of product dossiers for medical devices; among Class III medical devices currently undergoing approval, most imported products have already completed dossier preparation, while several provinces are piloting the development of product dossiers for Class II medical devices as well.

The National Medical Products Administration will adopt a strategy of “early engagement, tailored approaches for each enterprise, end-to-end guidance, and coordinated review‑and‑approval processes,” strengthening inter‑agency collaboration to support enterprises’ innovative R&D. At the same time, it will further leverage the regulatory authorities’ role in corrective oversight, effectively fostering an orderly, safe, and predictable regulatory environment that nurtures innovation. In addition, it will urge medical device registrants, filers, and relevant manufacturers to comprehensively enhance their quality management systems and rigorously fulfill their principal responsibilities. The administration will remain committed to deepening reforms of the review and approval system, bolstering cutting‑edge regulatory science research, and facilitating breakthroughs in critical core technologies. These efforts will help translate new pharmaceutical and medical technologies into marketable products and productive capacity, thereby promoting the mutually reinforcing advancement of industrial development and regulatory progress.

Reposted from: Chinese medicine Report