俄罗斯测试认证集团/海关联盟EAC认证中心

Центр сертификации EAC Таможенного союза ​ООО ТЕСТ СЕРТ 

上海经合工业设备检测有限公司    俄语区域产品认证专家

021-36411223      eac@cu-tr.org   WeChat:18621862553
俄罗斯医疗器械认证-俄罗斯输血系统注册-俄罗斯医用耗材认证,- 俄罗斯医疗器械医用缝合线认证,
来源: | 作者:pmt1ac5e9 | 发布时间 :2018-10-10 | 1950 次浏览: | 分享到:
俄罗斯医疗器械分类和欧盟医疗器械分类几乎完全一致,一般可以参照欧盟的分类进行。Medical Device (MDD)(医疗器械指令) 93/42/EEC 1.1.1995~15.6.1998/4/3 In Vitro Diagnostic Device (IVDD) (体外诊断医疗器械指令) 98/79/EC 7.6.2000~12.7.2003 考虑医疗器械之设计及制造对人体可能带来的危险程度,



Issued certificates of compliance for medical equipment are distinguished by the nature of the chosen assessment scheme, quality confirmation (voluntary or mandatory). In connection with the introduction of the adjustments to the Decision No. 982 on March 4, 2013, and specifically in the list of objects that fall under the norms of mandatory certification, medical products are referred in particular to the mandatory declaration. That is, a list of medical equipment required by law is not a certificate of conformity, but a declaration. Medical equipment is subject to the mandatory declaration, for example, nomenclature 9450. These include sterilization, disinfection, denture, dental equipment, as well as specialized tools, furniture, equipment, including electrical components, etc.

It should be noted that certificates of compliance for medical equipment as well as declarations are executed in compliance with all legal aspects. The procedure requires special knowledge, equipped laboratory and qualified personnel to certify the safety of medical equipment and instruments. Our certification center, having impeccable experience in this specialization, offers its customers a comprehensive solution to issues related to the production of medical products, transportation through customs posts outside the country and import into the territory of other countries. Legal import, export, operation and sale of medical equipment in the territorial zone of the Customs Union. You can get a certificate for medical equipment through our network resource, and at the same time receive a fast, reliable, affordable and high quality guaranteed positive result. Highly qualified specialists of our company are waiting for your requests at a convenient time for you and are happy to answer all questions on product certification in detail.

      

      

俄罗斯EAC认证中心

上海经合工业设备检测有限公司

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