Brazil’s Anvisa publishes guide about cyber security in medical devices
Anvisa publishes Guide 38/2020, “Principles and Practices of Cyber Security in Medical Devices”. The document is intended for anyone interested in ensuring the safe use of medical devices and will be useful for users of such equipment, patients, manufacturers, distributors, health services and researchers in the area of safety
Brazil’s Anvisa Announces New Medical Device Regulations
On September 18,2020 Brazil’s Anvisa published the RDC no. 423/2020 which deals with the extinction of the registration and migration of medical devices of risk class II to the notification regime.
ANVISA -RDC 305/2019- Regulation for Custom-Made Medical Devices
On October 2019, Anvisa published its formal regulations for custom-made medical devices “RDC 305/2019. “