Entering Greece market offers tremendous opportunities by medical device companies, but it is not without challenges. A professional partner with experience and expertise in Greece is a cornerstone for your success, which could be the difference between approval and failure. Here is the ultimate guide for Medical Device Registration in Greece with more details on device classification and approval process for Greece.
希腊以其众多岛屿而闻名，遍布爱琴海和爱奥尼亚海，是欧洲东南部的一个国家。希腊医疗保健市场，包括医疗设备，诊断，用品和药品，广泛依赖进口，当地产量主要积极于仿制药和所谓的“品牌泛型”。
让希腊成为欧洲的门户可以提供规模优势的国家经济。但是，金融危机，结合目前难民局势带来的不安，导致不稳定。政府正在最终确定某些医院单位的合并，并在所有公立医院内尝试二十四小时的运营标准，在医院金融交易和医院采购中具有更大水平的透明度。
医疗保健支出目前占希腊国内生产总值减少的5.4％（GDP）。该支出传统上包括约60％的政府提供的护理和40％的私人护理。偏好接受私人医疗保健的偏好传统上在希腊中较高，因为几乎任何程序都可以执行，私人医院的等待时间要低得多。
此外，如果一个程序需要一夜之间停留，公立医院的大幅拥挤和崩溃的外观是人们希望在有选择时避免的东西。尽管偏好，但较少的希腊公民可以负担不到口袋的私人护理或继续支付私人健康保险政策。
Medical devices in Greece are regulated by The国家药物组织(EOF), a public entity of the Ministry of Health. Greece, as a member of the European Union, classifies medical devices according to their risk into four classes: I, IIb, IIb, and III.
Class I medical devices are associated with the lowest risk, while Class III devices are associated with the highest risk. In order to market their medical devices throughout the European Union, manufacturers must make sure that all the products they intend to distribute in Greece are CE-marked.188bet金搏宝滚球作为当前欧盟法规内的符合性证明。
CE标记允许设备在所有欧盟成员国内销售。一旦医疗设备被CE标记授予，它可以在任何欧盟国家分发。188bet金搏宝滚球它不必在将要销售的国家/地区注册 - 在希腊注册给定医疗设备允许它分发在德国，法国，英国或任何其他欧盟成员国。
注册过程的时间框架可以根据设备的类型和类别而变化。该过程通常是I类设备最快的过程。同样重要的是要注意，欧盟的所有注册，以及希腊，有效期为5年。制造商也有义务有一个质量管理体系（QMS）。这方面最受欢迎的选择是ISO 13485认证，有效期为三年。
未在欧盟注册的国外制造商必须指定一项授权代表（AR），该代表将协助注册过程和市场后监督活动。
市场监测和警惕
In both the EU and the US, all medical devices are subject to further monitoring in order to assess their safety and performance efficiency. In the US one of the most important amendments in this regard is the Safe Medical Device Act that came into effect in 1990.
在欧盟，直到2017年，这个问题受到了监管医疗设备指令（MDD）。但是，这些指令最近被替换为EU MDR and IVDR regulations。
The Safe Medical Device Act in the United States brought lots of tension to the adverse event reporting process. Medical devices directives and the EU MDR/IVDR regulations have also created a uniformed regulatory situation in the EU. However, there are bigger variances in applicable regulations in the EU from country-to-country than in the US from state-to-state.
One example is that essentially all countries within the EU also have their own databases for monitoring medical devices and adverse reporting (EOF database) apart from Eudamed. Many countries also require extra information to provide, for example, Germany uses their ownDIMDI系统registrations processing.
188金宝搏网站靠谱吗沃林战略家在全球成功的医疗设备注册经验中享有很高的声誉和广泛赞誉。我们提供高质量，高效率和可靠的服务medical device regulatory consulting并向各国注册客户。作为医疗器械行业的监管事务专家，我们对所有类型的医疗设备或IVD都具有巨大的成功注册经验。188金宝搏网站靠谱吗佛罗典策略家是希腊医疗器械批准的绝对前导者，并使您的产品更快地进入希腊市场。