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全生命周期监管
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“向前一步”、“向深一尺” 智能网联汽车驶向监管深水区
日前,《市场监管总局工业和信息化部关于加强智能网联新能源汽车产品召回、生产一致性监督管 理与规范宣传的通知(征求意见稿)》(以下简称《征求意见稿》)向社会公开征求意见已告截止。 《征求意见稿》一经公布就在行业内引发高度关注。它延续了《关于进一步加强智能网联汽车产品准 入、召回及软件在线升级管理的通知》(以下简称《通知》)的要求,强化并提出了汽车智能化、网联 化趋势下,尤其是组合驾驶辅助系统加速推广、智能座舱领域创新应用不断涌现、OTA方式愈发普遍的 阶段,政府监管的导向与要点。 行业人士指出,《征求意见稿》的出台,意味着不仅监管方向更加明确、周期更加完整,针对的行业问 题更加精准,而且监管手段与措施也愈发具象化。 问题导向与全生命周期监管 上海机动车检测认证技术研究中心有限公司(上海汽检)前瞻技术部总工程师张帆认为,《征求意见 稿》有两个特点:一是问题导向,明确列举了当前优先要解决的4类不同产品安全问题,包括安全提示 和使用说明不完善,存在网络攻击、网络威胁和漏洞等数据安全风险,市场宣传乱象误导消费者,组合 驾驶辅助系统使用期间安全事件和碰撞等事故频发,从而抓住了行业一些具有普遍性的问题;二是全生 命周期、全 ...
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]