Abstract
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.
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