巴西医疗器械法规

《巴西医疗器械法规》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、ᐤ㾯५⯇ಘỠ⌅㿴ᆉ≨ڕTÜVSÜDGreaterChina15-11-29Mr.YongjianSUNRoadmapTÜVSÜDGreaterChinaMr.YongjianSUN䐟മ╄⽪⺞ᇊӗ૱࠶㊫ClassIClassIIClassIIIClassIV䘹ᤙањᐤ㾯ԓ㺘˄BrazilRegistrationHolder˅ӗ૱㧧ᗇINMETRO䇱Җ᧕ਇᐤ㾯ছ⭏ⴁⶓተ˄ANVISA˅ⲴGMPᇑṨ߶༷ᢰᵟ᮷Ԧ˄TechnicalFile˅/㓿⍾ؑ᚟ᣕ੺˄EconomicInformationReport˅BRHੁANVISAᨀӔ⌘޼⭣䈧AN

2、VISAᢩ߶⭣䈧ˈᒦޜ੺TÜVSÜDGreaterChinaMr.YongjianSUNTÜVSÜDGreaterChinaӰѸᱟANVISA•NationalHealthSurveillanceAgency(Anvisa˅ANVISAḷᘇᐤ㾯ഭᇦছ⭏ⴁⶓተDŽᡰᴹࠪਓᡆ䬰୞ࡠᐤ㾯ຳ޵५⯇ಘỠˈᗵ享俆൘ഭᇦছ⭏ⴁⶓተ˄ANVISA˅䘋㹼⌘޼TÜVSÜDGreaterChinaMr.YongjianSUNӰѸᱟINMETROINMETROḷᘇ•ᐤ㾯INMETROᱟᐤ㾯ഭᇦ䇑䟿ǃḷ߶ॆ઼ᐕъ䍘䟿ॿՊⲴᙫ〠㕙߉ˈ኎Ҿᐤ㾯ഭᇦ䇔ਟᵪᶴ઼ḷ߶ࡦᇊ㓴

3、㓷•ᐤ㾯Ⲵ䇔䇱ࡦᓖ࠶Ѫᕪࡦᙗ઼㠚ᝯᙗ䇔䇱ˈᖃᕪࡦᙗ䇔䇱Ⲵӗ૱ˈ䇔䇱ਸṬਾᗵ享䱴ᴹINMETROḷᘇ৺࣐䍤㓿INMETRO䇔ਟⲴㅜйᯩᵪᶴḷᘇˈᯩਟ䘋ޕᐤ㾯ᐲ൪•INMETROՊ䇔ਟаӋOCP-OrganismodeCertificaçãodeProduto(ProductCertificationBodywithnumber)䘋㹼INMETROӗ૱䇔䇱Ⲵᐕ֌.TÜVSÜDGreaterChinaMr.YongjianSUNᐤ㾯⌅ᖻ㌫㔏FederalConstitution㚄䛖ᇚ⌅FederalLaw㚄䛖⌅ᖻ(No.X.XXX)Resol

4、utionsߣ䇞(RDCNo.XX)NormativeInstructionsᤷই(INNo.X)Ordinances⌅Ԕ(No.XXX)TÜVSÜDGreaterChinaMr.YongjianSUNTÜVSÜDGreaterChinaᐤ㾯⌅㿴⌅㿴䈝䀰ᇑলࡦᓖGMP޵ᇩᤱ䇱Ӫࡦᓖ㖾ഭ⅗ⴏᰕᵜᐤ㾯ᐤ㾯⌅㿴⌅㿴⌅㿴⤜ᴹ⌅㿴࠶㊫㿴ࡉTÜVSÜDGreaterChinaMr.YongjianSUNClassificationMedicalDevice࠶㊫᮷Ԧ:RDCNo.185/2001˄ᐤ㾯Ⲵ93/42/EEC˅•઼⅗ⴏ࠶㊫㿴ࡉॱ࠶⴨լˈᙫ

5、ޡ18њ㿴ࡉDŽ–Rule1̚4Invasive–Rule5̚8Non-invasive–Rule9̚12Activedevice–Rule13̚18SpecialTÜVSÜDGreaterChinaMr.YongjianSUNClassification•Rule10•Rule11亴ᵏ⭘Ҿ䇺ᯝ઼ⴁᣔⲴ䇮༷኎ҾClassII˖ᡰᴹ⭘Ҿ㇑⨶㦟⢙ˈփ⏢䘋ࠪӪփⲴA)ྲ᷌䇮༷⭘Ҿ㇑⨶㻛Ӫփ੨᭦Ⲵ㜭ᴹⓀಘỠ䜭ᱟClassIIˈնᱟˈྲ᷌㘳䟿ˈ㘼䘉⿽㜭䟿৸нᱟ⭘ᶕ➗Ӟᛓ㘵㲁ࡠ⢙䍘Ⲵᙗ䍘ˈ⎹৺ࡠⲴ䓛փ䜘սˈⲴਟ㿱઼ᓄ⭘ᯩᔿㅹ▌൘Ⲵড䲙ˈӗ૱ࡉ኎B)ྲ

6、᷌䇮༷ᱟ⭘Ҿ᧒⍻᭮ሴᙗ㦟⢙࠶ҾClassIIIᐳⲴᡀۿ䇮༷C)⭘Ҿ䇺ᯝ઼ⴁᣔ䟽㾱Ⲵ⭏⨶䗷〻ˈնᱟˈྲ᷌㻛ⴁᣔⲴ৲ᮠՊሬ㠤⯵ӪⲴড䲙ˈ∄ྲᗳ㜿ˈબ੨ˈѝཞⴁᣔ㌫㔏ˈࡉᱟClassIII䇮༷DŽ亴ᵏਁሴ⭥⿫䗀ሴⲴ䇺ᯝ䇮༷ˈवᤜ᧗ࡦ䘉а䗷〻ˈᡆ㘵ᱟᖡ૽䘉а䗷〻Ⲵӗ૱ˈ䜭ᱟClassIIIDŽTÜVSÜDGreaterChinaMr.YongjianSUNTÜVSÜDGreaterChinaClassificationIn-vitroDevice࠶㊫᮷Ԧ:RDCNo.61/2011(ᐤ㾯Ⲵ98/79/EC)•ӗ૱࠶ѪClassIˈIIˈIIIˈIV

7、DŽ•Rule1toRule9TÜVSÜDGreaterChinaMr.YongjianSUNBrazilRegistrationHolderBrazilRegistrationHolder(BRH)ᐤ㾯ԓ㺘•ᖃࡦ䙐୶൘ᐤ㾯⋑ᴹᖃൠ⋑ᴹᆀޜਨᰦˈᗵ享ᤷᇊᐤ㾯⌘޼ԓ㺘Ӫ•䍏䍓൘ӗ૱⌘޼䗷〻ѝ઼ANVISA⋏䙊㚄㔌•ᐤ㾯Ⲵӗ૱⌘޼䇱ሶਚਁ㔉BRHˈ5ᒤ޵н㜭ᴤ᭩•INMETRO䇱Җሶਚਁ㔉BRH(newINMETROregulation,Portaria350/2010)•B-GMP䇱Җҏਁ㔉BRH•ਟԕᱟᐤ㾯Ⲵԓ⨶୶ˈҏਟԕᱟㅜйᯩˈ∄ྲ૘

8、䈒ޜਨ•᢯ᣵӗ૱Ⲵޘ䜘⌅ᖻ䍓ԫ˄઼EURepн਼˅•ㆮᆇⲴᇈᯩᦸᵳؑTÜVSÜDGreaterChinaMr.YongjianSUNINMETRO䇔䇱•ElectricalMedicaldevicesᕪࡦ䘋