Tag: Brazilian Regulations

Healthcare, Industry News, Medical Devices, Regulatory Affairs

ANVISA have introduced new clinical requirements for all novel medical device registrations and certain high-risk device

According to ANVISA’s recent announcement, the new clinical data requirements apply to qualifying devices submitted for review in both cadastro and registro registration routes. The key points from the technical notefor manufacturers are: Clinical data is now required for all novel devices. Some high-risk devices for which ANVISA determines safety and effectiveness may only be demonstrated via clinical […]

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