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...
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...
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...
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...
Brazil
The new article described in detail the aspects related to the evidence required for software products based on novel technologies, as well as to the determination of the regulatory status of the products depending on their functions and features. The Brazilian...
