5个欧亚国的政府已发布最终法规，建立一套用于各自管辖范围内的医疗器械和体外诊断医疗器械的协调监管体系。

据报道，俄罗斯、哈萨克斯坦、白俄罗斯、亚美尼亚和吉尔吉斯斯坦政府在2016年的早些时候就签署了欧亚经济联盟条约，但该条约中涉及到医疗器械法规的细节直到现在才得以揭晓。

欧亚经济联盟的成员国发布了有关拟实施的监管体系更多的深入要求：
 ●基于国际医疗器械监管机构论坛（IMDRF） / 全球协调工作组（GHTF）指南而制定的有关医疗器械和体外诊断试剂的安全性、质量、性能和有效性的基本原则
 ●医疗器械和体外诊断试剂的通用标签要求
 ●预申请检测和临床试验指导
  ♢IVD器械只需要进行临床试验，不需要技术检测
  ♢植入性医疗器械需要进行全面的临床试验
 ●建立并维护一个公共的医疗器械信息系统，包括所有五个欧亚经济联盟市场中获批的医疗器械、经认证临床检测中心和实验室以及上市后监测的数据
 ●一个被所有五个成员国认可的欧亚经济联盟医疗器械新“标志”

据报道，相关要求的更多细节即将出台；有些信息诸如人类受试者参与临床试验和外国制造商的授权代表还有待公布。

据预测，更多的法规将会在2016年夏季定稿并发布，但实施的时间表将在取得更多信息后予以公布。

从俄罗斯目前审批医疗器械的监管程序可以很好地得到欧亚经济联盟框架运作的初步信息。

Eurasian Governments Issue New Harmonized Medical Device Regulations

Governments of five Eurasian countries have issued final regulations to establish a harmonized regulatory system for medical devices and IVDs across their respective jurisdictions.

As Emergo reported earlier in 2016, the governments of Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan signed on to a Eurasian Economic Union Agreement, but few additional details of the agreement as it pertained to medical device regulations were available until now.

Emergo consultants in Russia as well as other sources now report that Eurasian Economic Union member states have issued more in-depth requirements for the regulatory system they intend to implement:
 ●Essential principles for safety, quality, performance and effectiveness of medical devices and IVDs based on guidance from the International Medical Device Regulators Forum (IMDRF)/Global Harmonization Task Force (GHTF)
 ●Common labeling requirements for devices and IVDs
 ●Guidelines for pre-submission testing and clinical trials
  ♢IVDs will only require clinical trials, not technical testing
  ♢Implantable devices will require full-scale clinical trials
 ●Setting up and maintaining a common medical device information system containing data on approved devices, accredited clinical testing centers and laboratories, and post-market surveillance data across all five Eurasian Economic Union markets
 ●A new Eurasian Economic Union medical device “mark” recognized by all five member countries

Details on additional requirements are forthcoming, according to our sources; information on human participation in clinical trials and authorized representation for foreign manufacturers, for example, still need to be released.

Emergo anticipates that additional regulations will be published and finalized in summer 2016, but will confirm implementation timelines once we obtain more information.

Russia’s current regulatory process for medical device approval provides good preliminary information on how the final Eurasian Economic Union framework may function. To learn more about the Russian medical device regulatory system, download our whitepaper and regulatory process chart.

【来源】Emergo 

【整理】TACRO