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...
Source LinkIVD（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...
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