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§ REGULATORY INTELLIGENCE

全球27大监管机构

来自全球主要医疗器械监管机构的实时监管情报。

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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