Medical Device Weekly Highlights (Feb 24 – Mar 2): Regulatory Approvals, Strategic Investments, and Policy Developments

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Under Yicheng BioClass II Device "Silk Fibroin Gel" Officially Approved

Innovative Product of Single-Use Balloon-Type Cryoablation Catheter Approved for Marketing

CR PHARMA COMM Establishes Pharmaceutical Innovation Fund in Chengdu High-Tech Zone, Builds CR PHARMA Western Innovation Center Covering Medical Device Innovation, Cell Preparation and Other Projects, and Acquires Nangkeer Biotechnology to Strengthen the Whole Industrial Chain Layout in the Blood Products Field. This Cooperation is Expected to Promote the Development of Pharmaceutical and Health Industry in Chengdu and Even China.

Recently, the International Electrotechnical Commission (IEC) officially released the international standard for elderly care robots (IEC 63310 "Performance Criteria for Proactive Assisted Living Robots Used in Connected Home Environments"), led by China in its development. This standard provides a benchmark for the design, manufacturing, testing, and certification of various elderly care robots based on the physiological and behavioral characteristics of the elderly, which will guide the healthy development of the global elderly care robot industry. The standard focuses on the needs and characteristics of the elderly in daily life, health care, and other aspects within connected home environments. Based on the level of assistance required by elderly users, it proposes functional and performance classifications for elderly care robots. In addition to general requirements such as usability, reliability, accessibility, energy consumption, and noise, it also sets technical requirements for health status and emergency monitoring services, communication support with family members and medical staff, diverse support for household chores, entertainment, home management, caregiving activities, mobility support for going out and walking, as well as information and data management performance.

Recently, the Shenzhen Municipal Government Press Office held a themed press conference on "Creating the Best Scientific and Technological Innovation Ecosystem and Talent Development Environment." Shenzhen will continue to focus on four key areas: policy, scenarios, innovation, and robotics. The city will accelerate the implementation of its policy "mega-package," offering enterprises subsidies of up to 60%, with a maximum of 10 million yuan in "Training Vouchers," as well as model vouchers, corpus vouchers, and scenario-based subsidies. This year, Shenzhen plans to raise 4.5 billion yuan in policy funds through multiple channels, and companies can start applying in March. Enterprises are encouraged to stay tuned. Additionally, Shenzhen will introduce special policies for humanoid robots, providing targeted support for opening application scenarios, breaking through key technologies, building specialized datasets, and enhancing large-scale manufacturing and application capabilities via methods such as "open competition." Meanwhile, artificial intelligence and robotics projects will be included in the city's major science and technology initiatives, encouraging industry, academia, research, and application entities to form innovative consortia for collaborative breakthroughs.

Recently, the official website of the National Medical Products Administration (NMPA) showed that the General Office of the NMPA issued a notice to the National Institutes for Food and Drug Control (CNIFDC, Medical Device Standard Management Center), stating that in order to meet urgent regulatory needs and promote the high-quality development of medical devices using brain-computer interface technology, the NMPA has approved the project for the formulation and revision of the industry standard "Quality Requirements and Evaluation Methods for EEG Datasets Used in Artificial Intelligence Algorithms in Medical Devices Using Brain-Computer Interface Technology." The General Office of the NMPA requires relevant departments to adopt a fast-track procedure for standard development, ensuring proper drafting, verification, solicitation of opinions, and technical review to guarantee the quality and level of the standard.

Recently, according to the WeChat Official Account of the National Healthcare Security Administration (NHSA), the NHSA conducted research in Haikou City, Qionghai City, and Baisha Li Autonomous County in Hainan Province. The research aimed to understand the progress in Party conduct and clean government construction within the healthcare security system, expansion of healthcare insurance coverage, use of nationally negotiated innovative drugs, the "three settlements" of medical insurance, the development of medical insurance data working groups, the collection and application of drug traceability codes, the "three advances" of centrally procured drugs, and real-world studies on medical insurance. The NHSA emphasized the need to leverage the advantages of medical insurance informatization to fully promote direct settlement, instant settlement, and synchronized settlement of medical insurance. It also called for accelerating the collection and application of drug and consumable traceability codes. Efforts should be made to establish a long-term care insurance system, make good use of grassroots medical resources, and integrate medical treatment with nursing care. By capitalizing on the strengths of the Free Trade Port, Hainan should become a highland for the use of innovative pharmaceuticals and medical devices, striving to lead nationwide in areas such as real-world data applications in medical insurance, the "three settlements" of medical insurance, and improving the business environment through medical insurance empowerment, thereby promoting high-quality development in medical institutions and the pharmaceutical industry.

Recently, the Tianjin Municipal Health Commission and the Municipal Disease Control Bureau have been deeply implementing the decisions and arrangements of the municipal Party committee and government. Focusing on the main task of high-quality development of health care, they have proactively planned and promoted the integrated development of public health services and industry. They aim to improve the platform for the transformation of scientific and technological achievements. Continuous enhancements are being made to the functions of the "Tianjin Health Science and Technology Achievement Transformation Information Platform" to provide comprehensive services such as "resource sharing, scientific and technological cooperation, incubation, achievement transformation, and technology promotion" in the fields of health care, disease prevention, and related areas, promoting precise matching between supply and demand. An innovative pharmaceuticals and medical devices application demonstration platform is being established. The construction of the "Tianjin Innovative Pharmaceuticals and Medical Devices Clinical Use Demonstration Center" is being advanced to explore the establishment of standardized and simplified access processes for innovative pharmaceuticals and medical devices, providing data support and application demonstrations for their widespread use. Efforts are also being made to promote the implementation of documents that provide full-chain support for innovation in the biopharmaceuticals sector, accelerating the adoption of innovative pharmaceuticals and medical devices in hospitals.

In accordance with the requirements of the Measures for the Administration of Medical Device Standards and the Specifications for the Management of Medical Device Standard Formulation and Revision, the National Medical Products Administration (NMPA) organized the selection process for the 2025 medical device industry standards formulation and revision projects. After soliciting public opinions and expert consultations, 85 projects for the 2025 medical device industry standards formulation and revision plan have been finalized and are now being announced. During the announcement period, if there are any objections, please provide feedback to the NMPA.