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依据产品批文,眼健康衍生品大致有以下几种分类:械字号即医疗器械。据《医疗器械监督管理条例》(国务院令第650号),共分3类:一类医疗器械,通过常规管理足以保证其安全性、有效性的医疗器械;二类医疗器械,对其安全性、有效性应当加以控制的医疗器械;三类医疗器械,植入人体,用于支持、维持生命,对人体具有潜在危险,对其安全性、有效性必须严格控制的医疗器械。境外的医疗器械需到北京国家食品药品监督局办理,境内的一、二类医疗器械在当地的省或市食品药品监督局办理,三类需到
According to product approval, eye health derivatives generally have the following categories: Weapon Name is the medical device. According to “Regulations on the Supervision and Administration of Medical Devices” (State Council Decree No. 650), there are three types of medical devices: a class of medical devices that are routinely managed to ensure their safety and effectiveness; medical devices of type II whose safety , The effectiveness of which should be controlled medical devices; three types of medical devices, implanted in the body, used to support and maintain life, is potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Foreign medical equipment to the Beijing State Food and Drug Administration, the territory of one or two types of medical equipment in the local provincial or city food and Drug Administration for the three categories to be