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5個(gè)歐亞國的政府已發(fā)布最終法規(guī)，建立一套用于各自管轄范圍內(nèi)的醫(yī)療器械和體外診斷醫(yī)療器械的協(xié)調(diào)監(jiān)管體系。

據(jù)報(bào)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(shí)候就簽署了歐亞經(jīng)濟(jì)聯(lián)盟條約，但該條約中涉及到醫(yī)療器械法規(guī)的細(xì)節(jié)直到現(xiàn)在才得以揭曉。

歐亞經(jīng)濟(jì)聯(lián)盟的成員國發(fā)布了有關(guān)擬實(shí)施的監(jiān)管體系更多的深入要求：
 ●基于國際醫(yī)療器械監(jiān)管機(jī)構(gòu)論壇（IMDRF） / 全球協(xié)調(diào)工作組（GHTF）指南而制定的有關(guān)醫(yī)療器械和體外診斷試劑的安全性、質(zhì)量、性能和有效性的基本原則
 ●醫(yī)療器械和體外診斷試劑的通用標(biāo)簽要求
 ●預(yù)申請檢測和臨床試驗(yàn)指導(dǎo)
  ?IVD器械只需要進(jìn)行臨床試驗(yàn)，不需要技術(shù)檢測
  ?植入性醫(yī)療器械需要進(jìn)行全面的臨床試驗(yàn)
 ●建立并維護(hù)一個(gè)公共的醫(yī)療器械信息系統(tǒng)，包括所有五個(gè)歐亞經(jīng)濟(jì)聯(lián)盟市場中獲批的醫(yī)療器械、經(jīng)認(rèn)證臨床檢測中心和實(shí)驗(yàn)室以及上市后監(jiān)測的數(shù)據(jù)
 ●一個(gè)被所有五個(gè)成員國認(rèn)可的歐亞經(jīng)濟(jì)聯(lián)盟醫(yī)療器械新“標(biāo)志”

據(jù)報(bào)道，相關(guān)要求的更多細(xì)節(jié)即將出臺；有些信息諸如人類受試者參與臨床試驗(yàn)和外國制造商的授權(quán)代表還有待公布。

據(jù)預(yù)測，更多的法規(guī)將會在2016年夏季定稿并發(fā)布，但實(shí)施的時(shí)間表將在取得更多信息后予以公布。

從俄羅斯目前審批醫(yī)療器械的監(jiān)管程序可以很好地得到歐亞經(jīng)濟(jì)聯(lián)盟框架運(yùn)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.

【來源】Emergo 

【整理】TACRO