Brazil eliminates a premarket approval pathway, instead allowing for premarket notification.
Previously, Brazil has had a “Cadastro” pathway to register Class II medical devices and IVDs. This pathway required more extensive documentation (like a technical dossier) for Class II and higher-risk Class I devices. However, on September 18, 2020, the Brazilian regulatory agency, National Health Surveillance Agency (ANVISA), eliminated the Cadastro pathway.
This change means that Class I and Class II devices will now solely fall under the “Notificação” pathway. The Notificação pathway is a pure notification process; it does not entail ANVISA approval in order to market a device. Device manufacturers should still have documentation available for review by ANVISA in the case of an audit, but the documentation does not have to be submitted prior to marketing. ANVISA’s intent in de-regulating lower-risk devices is to have more agency resources available to focus on higher-risk devices.
You can view the Resolution from ANVISA at this link (text in Portuguese): https://pesquisa.in.gov
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