Overview of Medical Device Anvisa Regulations in Brazil
The most important regulation for Medical Devices in Brazil is RDC 751/2022, which provides for the risk classification, notification and registration regimes, labeling requirements, and instructions for use of medical devices.
Australia’s TGA Medical Device Reform to reclassify certain medical devices
TGA has decided to reform their medical device classification due to safety issues identified and to further harmonize to the European Union.
Face Mask Regulations by Australia’s TGA
Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods).
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.