National Medical Products Administration: Formulate classification guidance principles for medical robots such as surgical robots and rehabilitation robots.
The State Drug Administration announced measures to optimize the supervision of the entire lifecycle to support the innovation and development of high-end medical devices. It will strengthen the classification and naming guidance for related products to support the registration of high-end medical devices. Guidelines for the classification of medical robots such as surgical robots and rehabilitation robots will be established, forming an expert consensus on the naming of medical robots. Research will be conducted on the management attributes and categories of new functions, technologies, and modalities such as medical AI devices, synthetic biomaterials, tissue engineering products, medical imaging pre-processing, and process optimization software, based on the maturity of technological development and dynamically adjusting the product management categories. Requirements for the management of core components of medical robots and high-end medical imaging equipment will also be further studied and refined.
Latest