CUTR Certificate of Conformity (EAC Certificate) certification process for medical devices
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作者:上海经合
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发布时间 :2025-06-06
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43 次浏览:
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The CUTR Certificate of Conformity (EAC Certificate) certification process for medical devices in the Eurasian Economic Union (EAEU) generally involves the following steps: 1. Determine product classification and applicable regulations Product classification: First, it is necessary to determine the specific category and risk level of the medical device. The EAEU has its own classification system for medical devices, which helps to identify the appropriate regulatory requirements. For example, different classes of medical devices (such as Class I, IIa, IIb, III) may have different certification procedures and requirements, similar to the EU's medical device classification. Identify relevant regulations: Identify the specific EAEU technical regulations (TR CU) applicable to the medical device. For medical electrical equipment, TR CU 004/2011 "On Safety of Low - Voltage Equipment" may be relevant; for electromagnetic compatibility, TR CU 020/2011 "On Electromagnetic Compatibility" may apply. In addition, there may be other specific regulations for certain types of medical devices
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海关联盟EAC认证中心 上海经合工业设备检测有限公司 电话:021-36411293 021-36411223 地址:中国上海浦东新区高科东路777号1号楼2017 邮箱: eac@cu-tr.org gost-r@163.com skype: gostchina 手机和微信WeChat:18621862553 www.cu-tr.org www.gost.org.cn
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