medical devices registration in the Federal Service for Surveillance in Healthcare register-医疗器械的概念涵盖范围广泛的产品——从设备、耗材到医用家具。 医用产品根据风险程度和功能分类——能量来源、与人体相互作用的方式等。为了在俄罗斯联邦和关税同盟的医疗机构中合法使用，所有医疗 设备必须通过联邦医疗保健监督服务登记处的医疗器械注册。
Federal Service for Surveillance in Healthcare conducts a documentation expertise, as well as sample testing and toxicological, biomedical and sanitary-hygienic tests. After these tests, in case of a positive result, the Federal Service for Surveillance in Healthcare enters the medical device into the State Register and issues a medical registration certificate. For successful further sale of medical devices, it is not enough just to register them. Next, you need to issue an EAC declaration, which confirms that the product meets the standards specified in the technical regulations, has the necessary qualities and characteristics for effective use in relation to its purpose. For some groups of goods, you will have to issue a certificate of conformity in the GOST-R (Russian National Standard) system. We will advise on these issues and show you what type of certification you need to complete for a specific type of medical equipment.
Pass all the procedures for the use of medical devices in Russia quickly and without unnecessary hassle
Our company has been providing comprehensive certification services for more than 9 years and helps to pass all tests for the successful import, sale and use of various products in the territory of the Eurasian Customs Union. The accredited body has all the resources to quickly resolve the issue with minimal worries for the client. Contact us.
