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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
FDA
United States
Class I, II, III
Health Canada
Canada
Class I, II, III, IV
EUROPE
EMA
European Union
Class I, IIa, IIb, III
MHRA
United Kingdom
Class I, IIa, IIb, III
Swissmedic
Switzerland
Class I, IIa, IIb, III
AEMPS
Spain
EU MDR classes
BfArM
Germany
EU MDR classes
ANSM
France
EU MDR classes
AIFA
Italy
EU MDR classes
AGES
Austria
EU MDR classes
Fimea
Finland
EU MDR classes
DKMA
Denmark
EU MDR classes
ASIA-PACIFIC
NMPA
China
Class I, II, III
PMDA
Japan
Class I, II, III, IV
TGA
Australia
Class I, IIa, IIb, III, AIMD
MFDS
South Korea
Class I, II, III, IV
CDSCO
India
Class A, B, C, D
HSA
Singapore
Class A, B, C, D
Medsafe
New Zealand
Class I, IIa, IIb, III
LATIN AMERICA
ANVISA
Brazil
Class I, II, III, IV
COFEPRIS
Mexico
Class I, II, III
ANMAT
Argentina
Class I, II, III, IV
INVIMA
Colombia
Class I, IIa, IIb, III
ISP
Chile
Class I, II, III, IV
MIDDLE EAST
SFDA
Saudi Arabia
Class A, B, C, D
NHRA
Bahrain
Class A, B, C, D
AFRICA
SAHPRA
South Africa
Class A, B, C, D