Core Insights - The IVD (in vitro diagnostics) industry is experiencing a wave of product deregistration, indicating a significant shift in the market dynamics from a "license dividend" era to a "refined cultivation" era [1][4][5] Group 1: Industry Trends - The Zhejiang Provincial Drug Administration announced the cancellation of five medical device registration certificates for Zhejiang Jukang Biological Engineering Co., marking the second mass deregistration in the IVD sector this year [1] - Other provinces, including Anhui, Jiangxi, Guangdong, and Hunan, have also initiated similar deregistration processes, with a total of 99 products deregistered in Hunan alone [2][3] - The number of IVD registration certificates in Hunan surged from 3,066 to 8,889 between 2020 and 2023, reflecting a compound annual growth rate of 30.49% [2] Group 2: Financial Implications - The average price of fluorescent immunoassay products dropped by 25% in the first half of 2023 compared to the previous year, leading to a significant reduction in profit margins from 60%-70% to 30%-40% [4] - The average price reduction for tumor markers and thyroid function tests exceeded 50% in a recent procurement round, severely impacting profit margins for companies [5] - The annual maintenance cost for a single IVD registration certificate ranges from 80,000 to 120,000 yuan, with companies like Derong Biological facing over 6.6 million yuan in maintenance fees for 83 certificates, which is 3.9% of their projected 2024 revenue of 170 million yuan [5] Group 3: Strategic Shifts - Companies are increasingly opting to deregister less competitive products to concentrate resources on core products with greater market potential and technological barriers [5][6] - The industry is urged to enhance technological innovation and focus on core products for sustainable long-term development [6]

21世纪经济报道记者唐唯珂报道 IVD(体外诊断)的退市潮悄然来袭。 近日，浙江省药监局发布一纸公告，宣布注销浙江聚康生物工程有限公司(以下简称"聚康生物")5个荧 光免疫检测产品的医疗器械注册证。这是继7月浙江省一次性清理82张生化试剂证照后，年内该省IVD 领域第二次"批量退市"。 短短三个月，同一省份两度"挥刀"，且注销数量从"两位数"跃升到"三位数"在即，信号意义远超事件本 身。集采压价、监管趋严、创新门槛抬高等因素正加速改写行业格局——中国体外诊断产业从"证照红 利"时代迈入"精耕细作"时代。 6月13日，湖南省药监局发布公告，8家企业申请注销99个产品的医疗器械注册证。其中德荣生物注销了 83个IVD注册证，自此已将其持有的全部IVD产品注册证"清空"。 7月22日，浙江省发布公告，一次性注销浙江凯成生物科技有限公司共82个试剂产品的医疗器械注册 证。 9月28日，安徽省药监局发布公告，应企业申请同意注销复星诊断科技(合肥)有限公司医疗器械注册 证。 把时间轴拉回到"注销潮"之前，行业其实经历过一轮轰轰烈烈的"拿证竞赛"。湖南药监局数据显示， 2020—2023年短短四年，全省二类IVD注册证存量 ...