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新余ISO13485医疗器械质量认证概况(2)

新(xīn)余ISO13485医(yī)疗器械(xiè)质量(liàng)认证概况(2)

  • 所属(shǔ)分类:新(xīn)余ISO13485

  • 点击次(cì)数:
  • 发布日期:2021/06/17
  • 在线(xiàn)询价
详细介绍

从培训起步助行(háng)业发(fā)展 医疗(liáo)器械(xiè)GMP认证稳步(bù)推进 
   823日~26日,国家食品药品监督管理局(SFDA)与美国商务部将在广州共同举(jǔ)办中美(měi)医疗器(qì)械生产(chǎn)质(zhì)量管理规(guī)范(GMP)培训班(bān)。业内人士认为,这意味着我国的医(yī)疗器械GMP认证(zhèng)已按照时间表(biǎo)逐步推进,医疗器械行业重新洗牌将不可避(bì)免。

据(jù)广东省食品药品监督(dū)管理局相关人士(shì)透露,2004SFDA已经开始(shǐ)讨论和制定(dìng)医(yī)疗(liáo)器械GMP认(rèn)证方案,今年将开始组建和培训医(yī)疗器械GMP认证队伍。目前(qián)SFDA有关医疗器械(xiè)GMP认证方案细则(zé)的意见稿正在(zài)商讨之中。

我国医疗器械企业的GMP认证工作今年开始(shǐ)试点,2006年将全面铺开,争取在3~4年内全部完(wán)成。届时(shí)新开(kāi)办的(de)企业都要通过认证才能领到(dào)生产(chǎn)许可证。SFDA今年(nián)上半年已经完(wán)成无(wú)菌医(yī)疗器械(xiè)和植(zhí)入性(xìng)医疗器械两(liǎng)个GMP分类(lèi)指南的制(zhì)定工作,选择代(dài)表性企业开(kāi)展试点(diǎn)工作,争取今年内完成试点(diǎn)工作(zuò)后予以正式发布。

据悉,SFDA的初步设想是:将GMP认证分(fèn)为3个阶段:生产血(xuè)袋、骨科内固定(dìng)器械(xiè)、生物填充材料等(děng)企业第一批通过GMP认(rèn)证,认证(zhèng)期(qī)限在(zài)1~2年后;第二阶段完成生产B超等产品的(de)企(qǐ)业的(de)认证;一般品种在第三阶(jiē)段,在(zài)3~4年内完(wán)成认证。还有一批产(chǎn)品(pǐn)不需要通(tōng)过GMP认证,比(bǐ)如压(yā)舌板(bǎn)、医用抬架等产品,可以依照医(yī)疗器械(xiè)生产管理条例监管。另外,初步计划要把生产CTMRI等大型医疗器械(xiè)的企业也(yě)放在(zài)第一阶段认证。

我国将于(yú)200611日起开始实(shí)施医疗器(qì)械GMP总则和一次性使用无(wú)菌医疗器械、植入性医疗器械的分类(lèi)实施指南。对新开办(bàn)的和(hé)申请换发《医疗器械生产企业许可证》的生产上述两(liǎng)类产品的医疗器械生产企(qǐ)业(yè),在(zài)通过医疗器械(xiè)GMP检查后(hòu),方可核发《医疗器(qì)械生产企业许可证》。

据了解,目前市场上(shàng)的一次(cì)性(xìng)注射器、骨科(kē)内固定器械、生物填充材料(liào)等医疗器械由于产品技(jì)术结构简单,对企业装(zhuāng)备、场地和人员的(de)要求不高,这类(lèi)产品出现问题较多(duō),一旦(dàn)出现问(wèn)题(tí),不仅影响面较广,对人体(tǐ)生理的伤害也较大,甚(shèn)至危及生(shēng)命。

据(jù)悉,欧洲(zhōu)GMP执(zhí)行的是ISO13485标准,我国打算在ISO13485的基础上借(jiè)鉴(jiàn)美国GMP的经验。在(zài)即(jí)将推行GMP认证(zhèng)的同时,SFDA也将加大(dà)对医疗器械的安全监管力度。但医疗器械和药品的GMP认证存在(zài)很大(dà)区别,医疗器械的生产材料(liào)有塑料(liào)、金属(shǔ)等许多种,因(yīn)此,认证的细节也将分为多种标准。

据(jù)广东省(shěng)食品药品监督管理局有关(guān)负责人介(jiè)绍,我国自1998年起至(zhì)今,在医疗(liáo)器械生产企业中一直(zhí)推行的是(shì)ISO9000产品(pǐn)认(rèn)证(zhèng),目前国际上已经出现(xiàn)比ISO9000更严格且专门适应医疗器械的ISO13485认证(zhèng)体系,估计SFDA在制定医疗器械GMP规范(fàn)时将结合ISO13485认(rèn)证体系(xì)中(zhōng)的一些要求。另外(wài),对医疗器(qì)械(xiè)临床试验(yàn)的监管,SFDA拟(nǐ)出台两(liǎng)个法(fǎ)规――“医疗器械临床试验管(guǎn)理办法医疗器械(xiè)临床试验机构资格认可(kě)管理办法。目(mù)前,这两个法(fǎ)规已基本拟定。另外,SFDA还将(jiāng)着(zhe)手建(jiàn)立(lì)医疗器械不良事件报告制度

SFDA近日已发(fā)出《关于执行〈医疗器械(xiè)生产监督管理办法〉有关问题的通知》(以下简称《通知》),对医疗器械GMP认证的实(shí)施框(kuàng)架进(jìn)行了说明。《通知》指出,医疗器械(xiè)GMP总则、不同(tóng)类别医疗(liáo)器械的分类实施指南以及重(chóng)点产品的生(shēng)产(chǎn)实施细则组成。

据统计(jì),目前我国总共有(yǒu)10446家(jiā)医疗器械生产企业,但(dàn)是(shì)产业规模(mó)相(xiàng)对比(bǐ)较小,产(chǎn)业技术也比较落后(hòu),所(suǒ)以国内企业医疗器械产品(pǐn)的(de)技术和质量都有待提(tí)高。而随着医(yī)疗器械企业GMP认证的深入进行,本土医疗器械(xiè)产品(pǐn)的安全(quán)性必将得以提高,同时医疗器(qì)械行业也将重新洗牌。

另外,今(jīn)年(nián)SFDA还要在全国建立多个(gè)医疗(liáo)器械技术审评中心,并(bìng)开展国内医(yī)疗(liáo)器(qì)械生产企业换发生产许可证的工作,以借此机会(huì)推行(háng)新行业标准和准备实施GMP认证,淘汰(tài)一些生产力低下的相(xiàng)关企业。


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关(guān)键词:南康市ISO13485认证,南(nán)康市ISO13485质量管(guǎn)理体系认证,南康市ISO13485管理培训

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