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歐亞國家政府發布新的醫療器械協調規定

2016-07-14 1312

5個歐亞國的政府已發布最終法規,建立一套用于各自管轄范圍內的醫療器械和體外診斷醫療器械的協調監管體系。


據報道,俄羅斯、哈薩克斯坦、白俄羅斯、亞美尼亞和吉爾吉斯斯坦政府在2016年的早些時候就簽署了歐亞經濟聯盟條約,但該條約中涉及到醫療器械法規的細節直到現在才得以揭曉。

歐亞經濟聯盟的成員國發布了有關擬實施的監管體系更多的深入要求:
 ●基于國際醫療器械監管機構論壇(IMDRF) / 全球協調工作組(GHTF)指南而制定的有關醫療器械和體外診斷試劑的安全性、質量、性能和有效性的基本原則
 ●醫療器械和體外診斷試劑的通用標簽要求
 ●預申請檢測和臨床試驗指導
  ?IVD器械只需要進行臨床試驗,不需要技術檢測
  ?植入性醫療器械需要進行全面的臨床試驗
 ●建立并維護一個公共的醫療器械信息系統,包括所有五個歐亞經濟聯盟市場中獲批的醫療器械、經認證臨床檢測中心和實驗室以及上市后監測的數據
 ●一個被所有五個成員國認可的歐亞經濟聯盟醫療器械新“標志”

據報道,相關要求的更多細節即將出臺;有些信息諸如人類受試者參與臨床試驗和外國制造商的授權代表還有待公布。

據預測,更多的法規將會在2016年夏季定稿并發布,但實施的時間表將在取得更多信息后予以公布。

從俄羅斯目前審批醫療器械的監管程序可以很好地得到歐亞經濟聯盟框架運作的初步信息。

英語原文



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.



【來源】Emergo 

【整理】TACRO

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