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...
Read More
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...
Read More
Nov 3, 2022
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...
Read More
Oct 27, 2022
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...
Read More
Oct 2, 2020
Brazil
The Agência Nacional de Vigilância Sanitária – National Health Surveillance Agency (Anvisa), a Brazilian regulating authority, has published guidance on cybersecurity issues related to medical devices. The document is dedicated to cybersecurity principles and...
Read More
Sep 23, 2020
Brazil
The National Health Surveillance Agency (ANVISA) of Brazil has announced changes in the regulations on Class II medical devices. The devices are allowed to be placed on the market under simplified (notification) procedure providing that it is sufficient for the...
Read More