歐亞國(guó)家政府發(fā)布新的醫(yī)療器械協(xié)調(diào)規(guī)定

4/4歐亞國(guó)家政府發(fā)布新的醫(yī)療器械協(xié)調(diào)規(guī)定5個(gè)歐亞國(guó)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(guó)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(guó)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(qǐng)檢測(cè)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(cè)

???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(chǎng)中獲批的醫(yī)療器械、經(jīng)認(rèn)證臨床檢測(cè)中心和實(shí)驗(yàn)室以及上市后監(jiān)測(cè)的數(shù)據(jù)

?●一個(gè)被所有五個(gè)成員國(guó)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(tái)；有些信息諸如人類受試者參與臨床試驗(yàn)和外國(guó)制造商的授權(quán)代表還有待公布。

據(jù)預(yù)測(cè)，更多的法規(guī)將會(huì)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。英語(yǔ)原文EurasianGovernmentsIssueNewHarmonizedMedicalDeviceRegulationsGovernmentsoffiveEurasiancountrieshaveissuedfinalregulationstoestablishaharmonizedregulatorysystemformedicaldevicesandIVDsacrosstheirrespectivejurisdictions.

AsEmergoreportedearlierin2016,thegovernmentsofRussia,Kazakhstan,Belarus,ArmeniaandKyrgyzstansignedontoaEurasianEconomicUnionAgreement,butfewadditionaldetailsoftheagreementasitpertainedtomedicaldeviceregulationswereavailableuntilnow.

EmergoconsultantsinRussiaaswellasothersourcesnowreportthatEurasianEconomicUnionmemberstateshaveissuedmorein-depthrequirementsfortheregulatorysystemtheyintendtoimplement:

?●Essentialprinciplesforsafety,quality,performanceandeffectivenessofmedicaldevicesandIVDsbasedonguidancefromtheInternationalMedicalDeviceRegulatorsForum(IMDRF)/GlobalHarmonizationTaskForce(GHTF)

?●CommonlabelingrequirementsfordevicesandIVDs

?●Guidelinesforpre-submissiontestingandclinicaltrials

???IVDswillonlyrequireclinicaltrials,nottechnicaltesting

???Implantabledeviceswillrequirefull-scaleclinicaltrials

?●Settingupandmaintainingacommonmedicaldeviceinformationsystemcontainingdataonapproveddevices,accreditedclinicaltestingcentersandlaboratories,andpost-marketsurveillancedataacrossallfiveEurasianEconomicUnionmarkets

?●AnewEurasianEconomicUnionmedicaldevice“mark”recognizedbyallfivemembercountries

Detailsonadditionalrequirementsareforthcoming,accordingtooursources;informationonhumanparticipationinclinicaltrialsandauthorizedrepresentationforforeignmanufacturers,forexample,stillneedtobereleased.

Emergoanticipatesthatadditionalregulationswillbepublishedandfinalizedinsummer2016,butwillconfirmimplementationtimelinesonceweobtainmoreinformation.

Russia’scurrentregulatoryprocessformedicaldeviceapprovalprovidesgoodpreliminaryinformationonhowthefinalEurasianEconomicUnionfra