●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
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.