§ REGULATORY INTELLIGENCE

27 Global Regulators

Real-time regulatory intelligence from every major medical device authority worldwide.

NORTH AMERICA

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

EUROPE

EMAEuropean UnionClass I, IIa, IIb, III MHRAUnited KingdomClass I, IIa, IIb, III SwissmedicSwitzerlandClass I, IIa, IIb, III AEMPSSpainEU MDR classes BfArMGermanyEU MDR classes ANSMFranceEU MDR classes AIFAItalyEU MDR classes AGESAustriaEU MDR classes FimeaFinlandEU MDR classes DKMADenmarkEU MDR classes

ASIA-PACIFIC

NMPAChinaClass I, II, III PMDAJapanClass I, II, III, IV TGAAustraliaClass I, IIa, IIb, III, AIMD MFDSSouth KoreaClass I, II, III, IV CDSCOIndiaClass A, B, C, D HSASingaporeClass A, B, C, D MedsafeNew ZealandClass I, IIa, IIb, III

LATIN AMERICA

ANVISABrazilClass I, II, III, IV COFEPRISMexicoClass I, II, III ANMATArgentinaClass I, II, III, IV INVIMAColombiaClass I, IIa, IIb, III ISPChileClass I, II, III, IV

MIDDLE EAST

SFDASaudi ArabiaClass A, B, C, D NHRABahrainClass A, B, C, D

AFRICA

SAHPRASouth AfricaClass A, B, C, D