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...
Brazil
The article provides an overview of the regulatory requirements for software as a medical device in Brazil. The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory...
Australia and Oceania
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
RegDesk News/Info
RIMS is a growing category of regulatory software solutions designed to help RA teams achieve faster submissions with fewer rejections. However, despite their novel nature, most platforms are already behind the times, technologically speaking. This article discusses...
EU MDR/IVDR
The European Commission (EC), the European authority in the sphere of medical devices, has proposed a new framework for the use of Artificial Intelligence technology in medical devices. The document is intended to introduce harmonized rules for AI-based medical...
