聚福彩票
FDA驗廠概況

FDA-QSR820驗廠

美國的醫療器械法規體系

       美國食品藥品監督管理局(FDA)是負責醫療器械管理的政府機構。其根據各相關法律授權而制定的各類法規性的文件編號為21CFRxxxx(xxxx為阿拉伯數字)。其中21CFR820是FDA根據《聯邦食品,藥品和化妝品法案》第501,502,510,513,514,515,518,519,520,522,701,704,801,803條款的授權而制定的規范醫療器械企業質量體系要求的法規,即Quality System Regulation,簡稱QSR或QSR820.

QSR820

       --又稱21CFR820,是美國醫療器械質量管理體系法規的英文縮寫,因其位于美國聯邦法規(Code of Federal Regulations)第21卷第820部分,故名;

       --QSR820是美國(人用)醫療器械制造商以及擬將產品銷往美國的外國(人用)醫療器械制造商必須遵守的質量管理體系法規,是多數醫療器械在美國上市之前必須遵守、上市之后隨時可能抽查的基本要求,這種抽查即通常所說的FDA醫療器械QSR820驗廠

       --符合性檢查:無論誰(FDA,或第三方機構)對工廠實施檢查,都只是一個(針對相關法規的)符合性檢查,不頒發任何證書,不屬于認證活動。

誰應該遵守QSR820?

       21QSR820.1規定:所有在美國和波多黎哥境內的,或有產品出口到美國和波多黎哥境內的醫療器械企業,必須按QSR820的要求建立質量體系,企業可根據實際情況,滿足QSR中與本企業制造活動相關的條款。

QSR820不適用

       --不適用于醫療器械零件生產商,但鼓勵這類企業以QSR820中適用的條款為指導;

       --不適用于人血和血制品生產商,這類企業應遵循21CFR606的規定。

誰負責驗廠

       FDA下屬的CDRH(器械與放射健康中心)是專職負責醫療器械企業管理的政府機構,其根據FDA的授權,安排檢查員到各企業進行工廠檢查。

驗廠抽查原則

       --根據法律規定,對未豁免QSR 820的產品的生產企業,進行例行檢查;(大多數情況)

       --II類器械或有510(K)注冊的器械的企業,容易被抽到;

       --為國外大公司做OEM的企業;

       --產品在美國市場發生質量事故的企業。

檢查頻率及費用

       美國境內企業:一般每兩年檢查一次;

       美國境外企業:不定期檢查;

       所有檢查費用由FDA承擔。

第三方機構代為審查

       在歐洲和美國本土(不適用于中國及港澳臺企業),FDA也授權第三方機構進行工廠檢查,委托企業需支付相應費用。這種委托第三方的檢查只是個別的,僅適于FDA檢查過并且無問題的企業,FDA對企業的首次工廠檢查不委托任何第三方進行。

驗廠指南

       QSIT(質量體系檢查技術)是FDA檢查員的必修課程,也是FDA Quality Systems Inspection Reengineering Team專門編制的檢查員手冊,詳細說明FDA審核員的檢查方法、關注點。

聚福彩票

<thead id="ltdfx"><listing id="ltdfx"><menuitem id="ltdfx"></menuitem></listing></thead>

<form id="ltdfx"><nobr id="ltdfx"><meter id="ltdfx"></meter></nobr></form>
<address id="ltdfx"></address>
<form id="ltdfx"></form>

2338tz.com | www.ty662.com | www.1754y.com | www.398244.com | 22753.com | www.84898v.com | www.96386b.com | sha9922.com | www.383050.com | www.7714a.com | 16630.com | www.56520y.com | www.6678566.com | kk3336.com | www.6491r.com | www.8582vv.com | 3616g.com | www.js888200.com | www.81455.com | 8294y.com | www.5y.cc | www.55885l.com | 1669s.com | www.055838.com | www.673266.com | 73657s.com | www.89677t.com | 55984v.com | j1503.com | www.6889797.com | 4066a.com | www.9846d.com | www.fh6116.com | 35222q.com | www.9906488.com | pcdd.net | www.yh6099.com | www.50732p.com | 30688a.com | www.808888e.com | 3066hhh.com | www.2846n.com | www.805462.com | 6363t.com | www.21202f.com | 28288u.com | www.997263.com | 8590.vip | www.4102z.com | qiangui001.com | www.6663ylg.com | 0805z.com | www.58665m.com | kk4255.com | www.5966lll.com | 5622r.com | www.183008.com | 0193355.com | www.808777.com | bjqxgs.com | www.59044.com | 911520.com | www.408409.com | so.com | www.xb0020.com | www.91233e.com | www.3170004.com | 16690088.com | www.993456.com | qq3189.com | www.ylg7777.com | 00oo8331.com | www.998948.com | 56987ff.com | www.88862.com | www.939884.com | www.agg066.com | www.627012.com | 1343.com | www.dfyk3.com | 1434f.com | www.0088wd.com | 83138m.com | www.789ww.com | feicai0312.com | www.63iii.com | 5003ll.com | www.81789.com | 26444w.com | www.k2678.com | 5003o.com | www.777888yh.com | www.398518.com | 15856g.com | www.535hc.com | 7276776.com | www.xj7009.com | bet577v.com | www.b32031.com | 8890aa.com | www.86339j.com | am556.cc | www.349229.com | 5099kk.com | www.5360uu.com | 33009193.com | www.109015.com | 67877p.com | www.88xxcp.com | i4389.com | www.f12189.com | b33668.com | www.vn888567.cc | 9694f.com | www.pjc66.vip | 4647099.com | www.9997018.com | 4018dd.com | www.42070013.com | 70118f.com | www.32czj.com | www.1347-03.com | www.022173.com | www.19yh6.com | hd4242.com | www.684344.com | www.0077jj.com | 0419y.com | www.vns22.me | 3435n.com | www.76520m.com | www.bjd333.com | www.51515e.com | www.lxyl360.com | 55899t.com | www.6613622.com | 8557a.com | www.00840b.com | www.108083.com | www.870013.com | www.242222.com | 12742n.com | www.55717.com | m0083.com | www.230966.com | www.203477.com | 2096r.com | www.960620.com | www.856458.com | www.936699.com | bo9.vip | www.bwinyz11.com | 44uu8332.com | www.388945.com | www.055755.com | 138.am | www.pujing95.com | hg0088.com | 2373c.com | www.wns123b.com | cc1331.com | 86811j.com | www.55070k.com | 40033rrr.com | www.912193.com | www.55268ww.com | dd4675.com | www.68568k.com | www.7893w50.com | p61653.com | www.hg77720.com | 3844ii.com | 80850y.com | www.5099aa.com | 8290z.com | 53166o.com | www.1764u.com | www.vns6266.com | 1624bb.com | www.cc00668.com | www.8520g.com | 2008oo.com | www.68682g.com | www.yz889.com | 3467y.com | www.711893.com | www.799666e.com | 9646c.com | www.846689.com | www.25468.com | 55818x.com | 1331ww.com | www.790964.com | www.284444.me | 1679abc.com | www.5856883.com | www.pj9799.com | 22098z.com | www.112070.com | www.70669a.com | www.33569900.com | 6363j.com | www.77114y.com | www.am185.com | 3640i.com | www.39500u.com | www.qiji333.com | www.65471188.com | m0007.com | www.500770.com | www.532159.com | 668cp77.com | 33599ee.com | www.bxcp4.com | www.cn365k.com | www.bet36365.com | 5554136.com | www.047788.com | www.36788p.com | www.06386699.com | www.www727939.com | 0033r.cc | 3957e.com | www.254499.com | www.166490.com | www.xpj20888.com | jsh600.com | jsjlb9.com | www.377192.com | www.7920t.com | www.179999.com | xpj5004.com | 9912304.com | www.c5638.com | www.758567a.com | www.333133b.com | sha152.com | pu65.com | www.7434b.com | www.2945g.com | www.cr689.com | 35222gg.com | 1669y.com | www.3479q.com | www.9737kk.me | www.vns78999.com | i47479.com | zjgcfc.com | www.081305.com | www.976917.com | www.68689g.com | www.tj58qp.com | www.hyi9.com | www.sb5202.com | 49964.com | 33382ww.com | www.330872.com | www.26299n.com | www.hg31118.com | www.wl6666.cc | 40400.com | 15a21.net | vdisk.cn | www.899485.com | www.wd088.com | www.759027.com | sss8827.com | 3552n.com | 8547rr.com | 1331d.com | www.877802.com | www.065825.com | www.pj88d.com | www.9992558.com | 6137.com | 4809q.com | tz1555.com | www.898134.com | www.71399g.com | www.12136v.com | www.hga66600.com | www.095889.com | www.28758p.com | 4488lll.com | 1777ca.com | 52599p.com | 6hcc99.com | www.52072p.com | www.357076.com | www.36008.com | www.428585.com | www.xpj70065.com | www.733665.com | 500000744.com | 4955f.com | 28288g.com | 68228j.com | www.090040.com | www.396.cc | www.87480.com | www.hgbet3.com | www.2021m.com | www.5220666.com | www.770405.com | www.pj88222.com | www.pjgansu.com | 8294l.com | zhcp25.com | 69111a.com | pj88ss.com | 9007893.com | 61320099.com | 1389kk.com | 78112211.com | h151515.com | www.106235.com | www.560721.com | www.732779.com | www.910336.com | www.3668p.com | www.26163c.com | www.84577.com | www.6364q.com | www.08588s.com | www.764169.com | www.ya2019k.com | www.hc779.com | www.96386k.com | www.334777.com | www.095928.com | www.588vip.cc | www.99677n.com | www.65707l.com | www.97365.com | www.621233.com | www.350c5.com | www.585167.com | www.7239w.com | www.323535.com | www.89777m.com | www.75600y.com | www.6939w.com | www.4323h.com | www.5647d.com | www.91233j.com | www.52072j.com | www.2109g.com | www.903117.com | www.c5823.com | www.638477.com | www.187516.com | 808988w.com | tt888v.com | www.26299o.com | 11449980.com | 6220ss.com | y4389.com | 9068x.com | 06388383.com | 1077jj.com | www.862365.com | www.88c07.com | www.333423.net | www.66930011.com | www.xn229.com | www.hg8hh.com | www.bwinyz04.com | www.4102b.com | www.26878m.com | www.820155.com | www.567306.com | 2546w.com | qy688.vip | 3807t.com | hwcp22.com | www.a8a8890.com | www.333133w.com | www.2289msc.com | www.u4042.com | www.68277555.com | www.2544g5.com | www.80065g.com | www.901376.com | www.178723.com | 3435i.com | 53262ss.com | 28758x.com | www.long6668.com | www.872879.com | www.8080999a.com | www.83033t.com | www.aa0090.com |