MEDTECH NEWS
China Releases Revised Guidelines for Registration Review of Mobile Medical Devices
09 05 2025China’s National Medical Products Administration released revised guidelines for mobile medical device registration (2025). The new document clarifies technical requirements, risk management, and cybersecurity standards for handheld, wearable, and software devices, aiming to ensure safety and regulatory consistency as mobile healthcare technologies advance. The rules take effect immediately.
Guidelines for the Performance Evaluation of Pathological Image AI Analysis Software: Ensuring Accuracy and Compliance in Medical Diagnostics
22 02 2024The "Key Points for the Performance Evaluation Review of Pathological Image AI Analysis Software" provides essential guidelines for the evaluation of AI software in pathology, covering data collection, algorithm performance, and safety standards to ensure the reliability and effectiveness of AI diagnostics tools.