Literatura e Folhetos de Processos do Grupo Emergo

Informativos grátis explicam o processo de aprovação regulatória de produtos médicos nos EUA, Europa, Japão. China, Coreia, México, Canadá, Rússia, Brasil, e Austrália. Formato PDF (em Inglês).

Regulatory Charts and Timeline Charts

AUSTRALIA - How to obtain regulatory approval for a medical device from TGA
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BRAZIL - How to obtain regulatory approval for a medical device from ANVISA
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CANADA - How to obtain regulatory approval for a medical device from Health Canada
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CHINA - How to obtain regulatory approval for a medical device from the Chinese SFDA
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EUROPE - How to obtain the CE Marking to sell a medical device in Europe
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INDIA - How to obtain regulatory approval for a medical device from the Medical Devices Division of the CDSCO
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JAPAN - How to obtain regulatory approval for a medical device from the Japanese PMDA
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MEXICO - How to obtain regulatory approval for a medical device from Mexico COFEPRIS
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RUSSIA - How to obtain regulatory approval for a medical device in the Russian Federation
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KOREA - How to obtain regulatory approval for a medical device from the KFDA
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UNITED STATES - How to obtain regulatory approval for a medical device from the US FDA
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Timeline Charts