The National Health Surveillance Agency (ANVISA), the Brazilian medical device regulating authority, announced the implementation of the special regulatory framework related to additional measures to be introduced to address issues related to the outbreak of the...
Asia
Philippines Food and Drug Administration (FDA), the national authority responsible for medical devices market regulation, has announced the implementation of a new regulatory framework for medical devices. New Medical Device Regulation: General Principles and...
North America
The last AI/ML blog described the basics, regulation, and premarket submission / modification. This blog will be discussing the risk categorization and TPLC (Total Product Life Cycle) of AI/ML-based SaMD. Artificial intelligence and machine learning is a new and...
