Field Medical Submits IPO Prospectus Following FDA Breakthrough Designation for FieldForce™ Ablation System

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Strategic CooperationQingyuan People's Hospital Partners with Field Medical to Advance Robotic Surgery Technology

Boston Scientific's New Generation Intravascular Ultrasound Diagnostic System Approved

Recently, the Fujian Provincial Drug Administration issued the "Fujian Province Drug, Medical Device, and Cosmetic Regulatory Enforcement Manual (Trial)." In terms of routine inspections, the Enforcement Manual provides detailed regulations on inspector qualifications and responsibilities, inspection preparation, methods, and procedures. Inspectors are required to possess professional competence, and inspection teams must operate in a standardized manner, adhere to legal administration, strictly follow inspection protocols and discipline, ensuring comprehensive and rigorous inspections. For different types of enterprises and entities, the Enforcement Manual outlines specific inspection key points. Regarding medical device regulation, it specifies detailed rules for enforcing quality management standards across production, operation, and use based on the risk levels of different categories of medical devices. For cosmetics, corresponding key points are organized according to different regulatory targets to ensure all-encompassing supervision.

Recently, the decision was made by the Jiangsu Province Strategic Emerging Industry Master Fund to approve sub-funds, two of which are proposed as participatory sub-funds for the Suzhou City Strategic Emerging Industry Specialized Master Fund. The proposed sub-fund for the Suzhou High-End Equipment Industry Specialized Master Fund is: Suzhou Jinyu Maowu High-End Equipment Fund, with a total scale of 1 billion yuan, registered and located in Changshu, Suzhou. It has a duration of 9 years and will mainly invest in early-stage, growth-stage, and mature-stage enterprises within the high-end equipment sector. The proposed sub-fund for the Suzhou Biomedical Industry Specialized Master Fund is: Suzhou Industrial Park Life Health Industry Fund, with a total scale of 1 billion yuan, registered and located in Suzhou Industrial Park. It has a duration of 11 years and will focus on innovative drugs with international competitiveness and domestically produced medical devices with independent intellectual property rights. The fund will prioritize growth-stage projects that have the potential to replace imported products at key upstream and downstream points in the industrial chain, while also considering outstanding technology enterprises in other subfields of the biopharmaceutical industry. This will further promote the upgrading and development of industries such as biopharmaceuticals and medical devices.

Recently, to accelerate the cultivation and development of new quality productivity, Sichuan Province has focused on six fields: artificial intelligence, aerospace, advanced equipment, biomanufacturing, clean energy, and advanced materials. It has laid out and implemented six major scientific and technological programs, coordinated and integrated scientific and technological innovation resources in Sichuan, concentrated efforts on technological breakthroughs and achievements transformation, and promoted the deep integration of scientific and technological innovation and industrial innovation. Key areas have been targeted for research tasks. In response to industry needs and future directions, the focus is on vertical large-scale industry models, aviation power, advanced nuclear energy, and more.23 key research directions, laying out 74 key tasks such as brain-computer interface, high-speed laser manufacturing, gene and cell therapy, and focusing on the development of landmark innovative products like X-ray Flash radiotherapy equipment and high-resolution photoresist.

Recently, the Beijing Municipal Medical Insurance Bureau and the Beijing Municipal Human Resources and Social Security Bureau jointly issued a notice, clarifying the adjustment of four medical service price items, including percutaneous venous catheterization, and including two chargeable surgical consumables—central venous catheters and chemotherapy pumps/implantable drug delivery devices—in the reimbursement scope of basic medical insurance and work-related injury insurance. The notice will take effect on December 28. According to the notice, the four adjusted medical service price items include percutaneous venous catheterization, venous catheter removal, implantable drug delivery device insertion, and implantable drug delivery device removal. The two chargeable surgical consumables included in the medical insurance and work-related injury reimbursement are central venous catheters and chemotherapy pumps/implantable drug delivery devices. Two existing related medical service price items—percutaneous femoral vein catheterization and percutaneous subclavian vein catheterization—will be simultaneously abolished.

Recently, the Optics Valley Medical Device Innovation Service Center was officially inaugurated. The Optics Valley Liaison Office of the Hubei Service Station for Medical Device Innovation of the Center for Medical Device Evaluation, National Medical Products Administration was also granted its plaque at the same time. It is reported that the Optics Valley Medical Device Innovation Service Center will link, gather, and integrate various elements at all stages of the medical device innovation chain and industry chain, providing full-chain services to medical device companies including research and design, registration testing, clinical research, registration application, and mass production services. The aim is to achieve "concentrating advantageous resources, assembling advanced forces, and gathering professional services" to promote rapid industry development. The center will adopt an "online + offline" service model. The online portal is scheduled to go live in the first quarter of 2025, enabling service applications, demand handling, project tracking, and effect evaluation, allowing companies to have a clear understanding of service content and progress.

Recently, the Hebei Provincial Medical Products Administration formulated the "Hebei Province Second-Class Medical Device Emergency Approval Procedure." This procedure applies to second-class medical devices that are urgently needed for public health emergencies and have no similar products available on the market in Hebei Province, or although there are similar products already on the market in our province, the supply cannot meet the emergency needs of a public health event. Such cases must be confirmed by the Provincial Medical Products Administration for review and approval. Applicants for emergency medical device approval should inform the local city Market Supervision Administration about the emergency need for the product and its development status. Each city's Market Supervision Administration should promptly understand the development of such medical devices, and if necessary, adopt early intervention to evaluate the proposed product and provide timely guidance to the registration applicant regarding relevant application procedures.

Recently, the Zhejiang Provincial Drug Administration introduced a series of relevant policies in the pharmaceutical supervision field to the media. In the emerging industry sector, as one of the dual leading units of the "415X" biomedicine and medical device industry cluster, the Zhejiang Drug Administration actively promotes the biomedicine industry—a national strategic emerging industry cluster—towards becoming a world-class cluster. Two comprehensive reform documents have been successively issued: the "Four Key Areas" Value-Added Service Management Measures (Trial) for the Biomedicine and Medical Device Industry Cluster and the Implementation Plan for Promoting Value-Added Reform of Government Services in Zhejiang’s Pharmaceutical Regulation Field. Additionally, specialized field documents in the "two products and one device" category have been gradually released, including the Pilot Program for Multi-Warehouse Integrated Management Reform of Pharmaceutical Wholesale Enterprise Groups in Zhejiang Province, the Guidance on the Administration of Record-Filing Materials for Domestic General Cosmetics in the Yangtze River Delta Region, and the 2024 Implementation Plan for Dual Improvement in Filing Capability and Quality of General Cosmetics in Zhejiang Province.

Recently, in order to advance the intelligent upgrade and digital transformation of the medical device industry, and to promote the deep integration of intelligent manufacturing and smart regulation of medical devices in Jiangsu Province, the Jiangsu Provincial Drug Administration held an exchange and discussion seminar in Nanjing on the integrated development of intelligent manufacturing and smart regulation of medical devices. At the meeting, the Medical Device Production Supervision Department introduced the current status, existing problems, and challenges of intelligent manufacturing of medical devices in Jiangsu Province, as well as the progress and future plans for the integration of intelligent manufacturing and smart regulation. Members of the research group on the integrated development of intelligent manufacturing and smart regulation of medical devices in Jiangsu Province, including the Provincial Institute of Quality and Standardization, Yuwell Group, Nanwei Medicine, Suhao Holdings, and Honghui Information, delivered presentations on topics such as the "Guidelines for Electronic Record-keeping in Medical Device Production Inspection" and the "Guidelines for Confirmation and Implementation of Electronic Record-keeping in Medical Device Production Inspection," service systems for production enterprises, and experience in building intelligent factories.