SaMD in Mexico — Overview
How COFEPRIS regulates Software as a Medical Device (SaMD) in Mexico — regulatory status, classification approach, and the evolving framework.
AI/ML Devices
Regulatory considerations for artificial intelligence and machine learning-based medical devices in Mexico under the evolving COFEPRIS framework.
IVD Digital & Point-of-Care Software
Regulatory considerations for digital IVD systems, point-of-care software, and laboratory information systems in Mexico.