National Medical Products Administration: Accelerate the release of standards for medical exoskeleton robots, radioactive isotope imaging equipment, and other related products.
The State Drug Administration issued a notice on measures to optimize the supervision and support the innovation and development of high-end medical devices throughout their lifecycle. It emphasizes the need to strengthen standard leadership for innovation and further improve the standard system for high-end medical devices. Accelerate the release of standards related to medical exoskeleton robots, radiopharmaceutical imaging equipment, etc. Speed up the revision of basic, common standards and method standards in the fields of medical robots, artificial intelligence medical devices, high-end medical imaging equipment, etc., and actively establish standardization technical organizations for medical robots and artificial intelligence medical devices. Strengthen the standardization research of new biological materials such as additive manufacturing medical materials, brain-machine interface flexible electrodes, and genetically engineered synthetic biological materials. Carry out research on standard datasets for artificial intelligence medical devices. According to the needs of industry development and supervision, promote the urgent standardization of high-end medical devices through a fast-track process.
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