全生命周期监管
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动力和储能电池行业,为能源行业高质量发展打个样
中国能源报· 2026-01-11 23:34
在行业面临价格内卷、产能过剩风险及安全隐患的当下," 进一步规范产业竞争秩序 "这一政策信号 为储能乃至能源其他产业未来发 展提供了路径参考。 ▲ 天合储能助力埃及首个公用事业级太阳能与储能一体化设施并网。 1月7日,工信部、国家发改委、市场监管总局、国家能源局联合召开动力和储能电池行业座谈会,16家龙头企业,包括13家电芯企业 和3家系统集成商参会,研究部署进一步规范产业竞争秩序。会议明确提出要强化市场监管、优化产能管理、支持行业自律及加强区域 协同。 此次会议不仅是对储能行业的实时规范,更被业内视为一份"高质量发展指南",标志着我国新能源产业管理思路从单纯的"鼓励做大"转 向"防范做烂",从"要素驱动"转向"创新与质量驱动"。在行业面临价格内卷、产能过剩风险及安全隐患的当下,这一政策信号为储能乃 至能源其他产业未来发展提供了路径参考。 从"价格战"转向"价值战" 近年来,我国储能产业迅猛发展,新型储能规模已跃居世界第一,拥有全球最完整、规模最大的产业链。然而,在繁荣之下,行业正经 历着剧烈的"阵痛期"。受多种因素影响,行业内盲目建设情况突出,低价竞争等非理性行为扰乱了正常市场秩序,不仅削弱了行业的盈 利能 ...
多地全链条护航 医疗器械创新加速 企业如何借势抢机遇?
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-02 23:10
2024年底,国务院办公厅发布《关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意 见》,提出到2027年,建成与医药创新和产业发展相适应的监管体系;到2035年,基本实现监管现代 化。 随后,各地陆续发布相关具体执行措施。北京近日发布的《若干措施》,从临床研发和注册上市、成果 落地和推广应用、生态集聚和链群发展、数字赋能和智慧升级、开放合作和出海远航五大维度提出具体 措施,促进行业发展。 多项举措备受关注。比如,在注册上市方面,对临床急需的创新医疗器械即收即检,无源医疗器械和诊 断试剂检验时限缩减至平均60个工作日,有源医疗器械检验时限缩减至平均90个工作日。在数字赋能方 面,支持医疗器械企业联合大模型企业开发部署行业大模型,鼓励医疗机构参考已有人工智能医疗服务 价格项目将新型人工智能辅助诊疗技术纳入使用。 近日,北京市经济和信息化局等六部门联合印发《北京市促进医疗器械产业高质量发展若干措施》(简 称《若干措施》),从五大维度推出15条具体措施,以推进医疗器械产业创新发展和提质升级,打造具 有国际影响力的高端创新医疗器械产业高地。 无独有偶,上海市人民政府办公厅也在同一时间印发《上海市全面深化药品医 ...
“向前一步”、“向深一尺” 智能网联汽车驶向监管深水区
Zhong Guo Qi Che Bao Wang· 2025-10-10 03:19
Core Viewpoint - The release of the draft notice for strengthening the recall and supervision of intelligent connected new energy vehicles signifies a more precise and comprehensive regulatory approach in the industry, particularly in the context of the rapid promotion of advanced driver-assistance systems and innovations in smart cockpit applications [2][3][4]. Group 1: Regulatory Focus - The draft notice emphasizes a problem-oriented approach, identifying four priority safety issues that need to be addressed, including inadequate safety prompts, data security risks, misleading market promotions, and frequent safety incidents during the use of driver-assistance systems [3][4]. - It establishes a full lifecycle and process safety management framework, providing legal basis and implementation norms for the supervision of intelligent connected vehicles [3][4]. - The document clarifies corporate responsibilities regarding product consistency, recall management, and promotional activities, including prohibiting misleading advertising [3][4][5]. Group 2: Enforcement Mechanisms - The draft notice provides specific enforcement mechanisms for regulatory authorities, allowing for targeted checks on technical parameters, OTA records, and accident reports [4][5]. - It introduces a three-dimensional approach to supervision, including routine compliance checks, targeted investigations, and special audits to ensure comprehensive coverage of regulatory requirements [5][6]. - The emphasis on actionable, verifiable, and accountable measures indicates a shift from theoretical regulations to practical enforcement [4][5]. Group 3: Industry Adaptation - The new regulatory framework is expected to prompt a reevaluation of the development logic for driver-assistance functions, prioritizing safety, stability, reliability, and prudence in product development [7][11]. - Companies are encouraged to adopt a proactive approach to safety risk management throughout the entire lifecycle of intelligent connected vehicles, from research and development to production and post-market activities [6][7]. - The draft notice is likely to accelerate the development and application of driver monitoring systems and enhance the overall safety culture within the industry [10][11]. Group 4: Testing and Compliance - Testing institutions are expected to enhance their capabilities to support both corporate R&D and regulatory compliance, transitioning from surface-level compliance to in-depth code-level verification [9][10]. - The draft notice necessitates the establishment of a comprehensive testing framework that includes functional safety, cybersecurity, and data compliance assessments [9][10]. - There is a call for the creation of a national testing scenario database and evaluation standards to support the evolving regulatory landscape [11].
国家药监局:加快制定医用手术机器人、重组胶原蛋白等高端产品的质量管理体系检查要点
news flash· 2025-07-03 10:13
Core Viewpoint - The National Medical Products Administration (NMPA) is accelerating the establishment of quality management system inspection points for high-end medical products, including surgical robots and recombinant collagen, to support the innovation and development of high-end medical devices [1] Group 1: Regulatory Measures - The NMPA has announced measures to optimize the lifecycle supervision of high-end medical devices, focusing on innovative products [1] - Regulatory discussions will be held for representative innovative medical devices, guiding local supervision in provinces with concentrated innovation [1] - The NMPA aims to analyze innovation points and risk points, and develop targeted regulatory measures [1] Group 2: Quality Management System - The NMPA is expediting the formulation of inspection points for quality management systems for various innovative products, including carbon ion/proton therapy systems and animal-derived artificial heart valves [1] - High-end products such as surgical robots, AI medical devices, and recombinant collagen will also have specific quality management system inspection points established [1] Group 3: Capacity Building - The NMPA plans to strengthen the selection and training of national-level inspectors for high-end medical devices [1] - There will be efforts to validate the quality management systems of provincial inspection agencies and enhance their capabilities [1] - The goal is to improve the quality and efficiency of inspections conducted by provincial agencies [1]