21世纪经济报道记者 唐唯珂 报道 第六批耗材国采拉开帷幕。 11月7日，北京市医保局发布《关于开展药物涂层球囊类、泌尿介入类医用耗材采购需求填报工作的通 知》，标志着第六批国家组织高值医用耗材集中采购正式进入采购需求量填报阶段。作为继人工关节、 冠脉支架等品类之后的又一重要集采动作，此次聚焦两大临床刚需领域，叠加创新采购规则的落地，将 对百亿级市场版图重构、国产替代进程及行业高质量发展产生深远影响。 对于企业而言，需求填报的启动意味着集采竞争进入倒计时。"近期的工作集中在结合各省份的临床需 求数据、过往集采中标情况，测算合理的报价区间。" 国内某头部医疗器械企业销售负责人向21世纪经 济报道记者表示，"目前业内开始认可，逐渐集采不是'价格战'，而是'性价比战'，企业端需要在保证利 润空间的前提下，报出有竞争力的价格，同时通过规模效应降低生产成本。" "稳临床、保创新" 本次集采明确锁定药物涂层球囊与泌尿介入两大类高值医用耗材，覆盖范围与筛选逻辑充分贴合临床实 际需求。 其中，药物涂层球囊细分为冠状动脉及外周血管用等多个细分品种，全面覆盖心血管疾病介入治疗核心 场景；泌尿介入类则从前期规划的25类精简至输尿管 ...

Core Viewpoint - The sixth batch of high-value medical consumables national procurement is shifting towards a focus on quality and stability rather than just price competition, as indicated by the draft proposal that emphasizes "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [1][10]. Group 1: Procurement Framework - The draft proposal highlights the selection of consumables that are "clinically essential," particularly focusing on drug-coated balloon catheters and urological intervention products, which cover over 90% of mainstream clinical usage [3]. - The proposal introduces a "price ceiling" for bids, with drug-coated balloon catheters' maximum bid based on previous provincial procurement prices, averaging around 6,300 yuan in Jiangsu and 6,000 yuan in the Beijing-Tianjin-Hebei region [4]. - A "price anchor" mechanism is established to prevent low-price bidding, requiring companies to justify costs if their bids fall below a certain threshold, addressing previous issues of unsustainable low pricing [5]. Group 2: Market Dynamics - The adjustments in procurement rules are seen as a means to facilitate industry restructuring rather than merely a price war, with a shift from price competition to value competition [7]. - The domestic market for drug-coated balloon catheters is expected to strengthen, with local brands increasing their market share from 20% to over 70% due to competitive pricing and improved technology [7][8]. - The proposal allows for a 20% market reserve to support innovative products, ensuring that the procurement process does not hinder innovation while maintaining quality standards [10]. Group 3: Quality Control Measures - Stringent quality control measures are included, with all selected companies subject to on-site inspections, and low-priced products will be prioritized for quality checks [9]. - Companies found to have quality issues or supply violations will face disqualification from future procurement opportunities for 1 to 3 years, reinforcing the importance of maintaining product standards [9].