China's NMPA released the 2025 Medical Device Standards Plan, detailing 6 mandatory and 79 recommended standards covering AI, nanotechnology, biomaterials, and robotics. Some standards align with international benchmarks to enhance global competitiveness. The plan promotes high-quality development through collaboration among regulatory bodies, ensuring safety, innovation, and compliance.
China's NMPA released the 2025 Medical Device Standards Plan, detailing 6 mandatory and 79 recommended standards covering AI, nanotechnology, biomaterials, and robotics. Some standards align with international benchmarks to enhance global competitiveness. The plan promotes high-quality development through collaboration among regulatory bodies, ensuring safety, innovation, and compliance.
The National Medical Products Administration (NMPA) of China has announced 10 new medical device industry standards. These standards cover various medical devices including hemodialysis systems, surgical implants, high-frequency ventilators, and in vitro diagnostic reagents. The standards will be implemented between March 2026 and March 2028, aiming to enhance medical device safety and quality control.