|Tao Li, Dezhi Lu, Ya Ren, Tianchang Wang, Yuanjing Xu, Zhenjiang Ma, Xin Sun, Lei Qiang, Xue Yang, Guohong Shi, Tao Xu, Neng Xie, Ming Guo, Qingfeng Zeng, Jian Sun, Xiaodong Cao, Bo Zhang, Yong He, Maling Gou, Baolin Li, Miao Zhou, Weijie Peng, Lei Hou, Keqin Zhang, Xin Jiang, Xi Yang, Chungkuang Chen, Jinwu Wang, Kerong Dai
Digit Med 2022, 8:6 (21 April 2022)
Bioprinting is expected to be a revolutionary technology for application in medicine, bringing hope to countless patients. For a long time, many patients have been experiencing a lack of suitable organs for transplantation, which eventually lead to loss of lives. Bioprinting technology can integrate cells, proteins, cytokines, and other supporting materials, such as biomaterials and hydrogels, to produce biomedical devices with biological functions. However, no bioprinting medical devices have been approved by the National Medical Products Administration, with specific registration and regulatory requirements for bioprinting medical devices still needing to be explored. To standardize the Bioprinting Medical Devices Special Requirements for Quality Management System, Chinese experts in relevant fields were organized to formulate this expert consensus.