The National Medical Products Administration: Accelerate the release of relevant standards for medical exoskeleton robots, radioactive nuclide imaging equipment, and more

The National Medical Products Administration has issued a notice to optimize the regulatory support for the entire lifecycle of high-end medical device innovation, which points out the need to strengthen standard-led innovation and further improve the standard system for high-end medical devices. It aims to accelerate the release of relevant standards for medical exoskeleton robots, radioactive nuclide imaging equipment, and more. The work on the formulation and revision of basic, general standards, and method standards in the fields of medical robots, artificial intelligence medical devices, and high-end medical imaging equipment will be expedited, and efforts will be made to actively establish standardization technical organizations for medical robots and artificial intelligence medical devices. There will be an emphasis on the standardization research of new biomaterials such as medical materials for additive manufacturing, flexible electrodes for brain-machine interfaces, and genetically engineered synthetic biomaterials. Research on standard data sets for artificial intelligence medical devices will be conducted. According to industrial development and regulatory needs, the rapid procedures will be used to promote the project establishment of urgently needed standards for high-end medical devices