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§ REGULATORY INTELLIGENCE

全球27大監管機構

來自全球主要醫療器材監管機構的即時監管情報。

NORTH AMERICA

FDAUnited StatesClass I, II, IIIHealth CanadaCanadaClass I, II, III, IV

EUROPE

EMAEuropean UnionClass I, IIa, IIb, IIIMHRAUnited KingdomClass I, IIa, IIb, IIISwissmedicSwitzerlandClass I, IIa, IIb, IIIAEMPSSpainEU MDR classesBfArMGermanyEU MDR classesANSMFranceEU MDR classesAIFAItalyEU MDR classesAGESAustriaEU MDR classesFimeaFinlandEU MDR classesDKMADenmarkEU MDR classes

ASIA-PACIFIC

NMPAChinaClass I, II, IIIPMDAJapanClass I, II, III, IVTGAAustraliaClass I, IIa, IIb, III, AIMDMFDSSouth KoreaClass I, II, III, IVCDSCOIndiaClass A, B, C, DHSASingaporeClass A, B, C, DMedsafeNew ZealandClass I, IIa, IIb, III

LATIN AMERICA

ANVISABrazilClass I, II, III, IVCOFEPRISMexicoClass I, II, IIIANMATArgentinaClass I, II, III, IVINVIMAColombiaClass I, IIa, IIb, IIIISPChileClass I, II, III, IV

MIDDLE EAST

SFDASaudi ArabiaClass A, B, C, DNHRABahrainClass A, B, C, D

AFRICA

SAHPRASouth AfricaClass A, B, C, D
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