Brazil
The new article addresses aspects related to the way eligibility for registration should be determined. Table of Contents The Brazilian regulating authority in the sphere of medical devices (ANVISA) has published a guidance document dedicated to the importation of...
Brazil
The article provides an overview of the applicable regulatory requirements in the sphere of importation of medical devices the parties involved should comply with to be allowed to undertake such activities. Table of Contents The Brazilian regulating authority on...
Brazil
The new article addresses the aspects related to the regulatory requirements to be applied with respect to the software products intended to be used for various purposes, including diagnosing and interaction with laboratory equipment. Table of Contents The Brazilian...
Brazil
The new article describes in detail the aspects related to the products intended to process medical records, as well as the ones based on the use of non-medical hardware platforms (smartphones). Table of Contents The Brazilian regulating authority in the sphere of...
Brazil
The new article highlights the points related to the regulatory approach to be applied in the case of various products intended to collect and process electrocardiography data. Table of Contents The Brazilian regulating authority in the sphere of healthcare products...
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...
