Nov 23, 2022
Brazil
The new article provides additional clarifications regarding the regulatory status of software products with different types of supply, including software to be installed, cloud solutions, and complex products composed of multiple elements. Table of Contents The...
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Nov 23, 2022
Brazil
The new article describes in detail the aspects related to various software products, including the ones intended for remote diagnostics or facilitating administrative procedures. Table of Contents The Brazilian regulating authority in the sphere of healthcare...
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Nov 17, 2022
Brazil
The article addresses the aspects related to the products used for the provision of telemedicine services. Table of Contents The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published a guidance document dedicated to the regulatory...
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Nov 10, 2022
Brazil
The new article provides details regarding the regulatory matters related to the responsibilities of the parties involved, telemedicine, accessories, and languages in the context of software as a medical device. Table of Contents The Brazilian regulating authority in...
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Mar 14, 2019
RegDesk News/Info
Changes to Class I Medical Device Requirements in Brazil Agência Nacional de Vigilância Sanitária (ANVISA) is the regulatory body responsible for the regulation and approval of pharmaceuticals and medical devices in Brazil. On March 3, 2019, ANVISA published a...
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