Medical devices that look like medicines: safety and regulatory concerns for children in Europe

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Medical devices that look like medicines: safety and regulatory concerns for children in Europe

机译：看起来像药物的医疗器械：欧洲儿童的安全和监管问题

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Introduction Medical devices (MedDevs) and medicines are assessed (and monitored) differently before and after launch. There are products for repeated oral ingestion that are marketed in the European Union as MedDevs.

机译：介绍医疗设备（Meddevs）和药物在发射之前和之后评估（和监控）。作为Meddevs的欧洲联盟销售的重复口服摄取有产品。

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《Archives of disease in childhood》 |2020年第2期|共8页
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正文语种 eng
中图分类儿科学;
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1. Medical devices that look like medicines: safety and regulatory concerns for children in Europe [J] . Archives of disease in childhood . 2020,第2期

机译：看起来像药物的医疗器械：欧洲儿童的安全和监管问题
2. The role of the Therapeutic Goods Administration and the Medicine and Medical Devices Safety Authority in evaluating complementary and alternative medicines in Australia and New Zealand. [J] . Ghosh D, Skinner M, Ferguson LR Toxicology: An International Journal Concerned with the Effects of Chemicals on Living Systems . 2006,第1期

机译：在澳大利亚和新西兰，治疗产品管理局和医学与医疗器械安全管理局在评估补充和替代药物方面的作用。
3. Queen's speech: employment, medicines, medical devices and health service safety investigations [J] . Liability, Risk & Insurance . 2020,第353期

机译：女王的讲话：就业，药品，医疗器械和卫生服务安全调查
4. "Brilique /Ticagrelor/ Safety Profile related to threshold of Toxicological concern /TTC/ for impurities Ul127, Ul133,Ul134 and Ul 111 major objections of evaluation documentation for granting MA procedure by Medicines and Medical Devices Agency of Serbia-ALIMS [C] . Stanimirovic V., Nikolic A., Nikolic D., European Congress of Pharmacology . 2012

机译：“与毒理学关注的阈值/ TTC / TTC /杂质/杂质UL127，UL133，UL134和UL 111通过塞尔维亚 - Alims的药物和医疗器械机构授予MA程序的评估文件的主要反对意见
5. Comprehending the Safety Paradox and Privacy Concerns with Medical Device Remote Patient Monitoring [D] . Doyle, Marc . 2019

机译：理解医疗器械远程患者监测的安全悖论和隐私问题
6. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines [O] . Josep Pane, Preciosa M. Coloma, Katia M. C. Verhamme, -1

机译：评价非活性植入式医疗器械与药物的安全性
7. Report drawn up on behalf of the Committee on Economic and Monetary Affairs on proposals from the Commission of the European Communities to the Council on the elimination of technical barriers to trade in particular, proposals for directives on the approximation of laws of theMember States relating to:safety belts and restraint systems and head restraints of seats of motorvehicles (Doe. 464/74);headlights for motor vehicles emitting an asymmetrical passing beam or adriving beam or both, and to incandescent electric lamps for suchheadlights (Doe. 452/74);side lights, rear lights and stop lights for motor vehicles and their trailers(Doe. 457/74);the rear registration-plate illuminating device of motor vehicles and theirtrailers (Doe. 450/74);towing hooks on motor vehicles (Doe. 462/74);the roll-over protection structures of wheeled agricultural or forestrytractors (Doe. 456/74);the type-approval of motorcycles (Doe. 463/74 );alcoholometers and hydrometers for alcohol and alcohol tables(Doe. 406/74);electromedical equipment and medical X-ray equipment operating at 10to 400 kV (Doe. 453/74);common provisions for constructional plant and equipment; themeasurement of the sound level of constructional plant and equipment;the permissible sound level for pneumatic concrete-breakers andjackhammers (Doe. 454/74); 'appliances using gaseous fuels, safety and control devices for theseappliances and methods for inspecting these appliances and appliancesusing gaseous fuels for the instantaneous production of hot water forsanitary purposes (Doe. 459/74). Working Documents 1974-1975, Document 517/74, 10 March 1975 [O] . 1975

机译：代表经济和货币事务委员会就欧洲共同体委员会向理事会提出的关于消除贸易技术壁垒的建议提出的报告，关于近似法律的指示的提案成员国涉及：安全带和约束系统以及电动机座椅的头枕车辆（Doe.464 / 74）;用于发出不对称通过光束或a的机动车辆的前灯驱动光束或两者，以及用于此类的白炽电灯头灯（Doe.452 / 74）;汽车及其拖车的侧灯，尾灯和刹车灯（Doe.457 / 74）;机动车后置板照明装置及其机动车拖车（Doe.450 / 74）;机动车辆上的牵引钩（Doe.462 / 74）;轮式农业或林业的翻车保护结构拖拉机（Doe.456 / 74）;摩托车的型式认可（Doe.463 / 74）;用于酒精和酒精表的酒精计和比重计（Doe.406 / 74）;电子医疗设备和医疗X射线设备运行在10到400 kV（Doe.453 / 74）;建筑工厂和设备的共同规定;该测量建筑工厂和设备的声级;气动混凝土破碎机允许的声级手提钻（Doe.454 / 74）; “使用气体燃料的设备，这些设备的安全和控制装置用于检查这些器具和器具的器具和方法使用气态燃料瞬间生产热水卫生用途（Doe.459 / 74）。工作文件1974-1975，文件517/74，1975年3月10日

Medical devices that look like medicines: safety and regulatory concerns for children in Europe

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