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CONSENSUS
Year : 2022  |  Volume : 8  |  Issue : 1  |  Page : 6

Expert consensus on quality management system of bioprinting medical devices special requirements


1 Department of Orthopaedic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; Department of Orthopaedics, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
2 School of Medicine, Shanghai University, Shanghai, China
3 School of Medicine, Southwest Jiaotong University College of Medicine, Chengdu, Sichuan Province, China
4 Department of Orthopaedic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
5 School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China
6 Department of Mechanical Engineering, Tsinghua University, Beijing, China
7 Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, China
8 Department of Thoracic and Cardiovascular Surgery, Affiliated Hospital of Xiamen University, Xiamen, Fujian Province, China
9 International Center for Materials Discovery, School of Materials Science and Engineering, Northwestern Polytechnical University, Xi'an, Shaanxi Province, China
10 Department of Surgical, Nanjing Children's Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu Province, China
11 Material Science and Engineering School, South China University of Technology, Guangzhou, Guangdong Province, China
12 Department of Dermatology, Tangdu Hospital of Air Force Medical University, Xi'an, Shaanxi Province, China
13 State Key Laboratory of Fluid Power and Mechatronic Systems, School of Mechanical Engineering, Zhejiang University, Hangzhou, Zhejiang Province, China
14 Department of Biotherapy, Cancer Center, Sichuan University, Chengdu, Sichuan Province, China
15 Shenzhen Pingle Orthopedics Hospital, Shenzhen, Guangdong Province, China
16 Department of Stomatology, Guangdong Provincial People's Hospital, Guandong Academy of Medical Science, Guangzhou, Guangdong Province, China
17 Gannan Medical University, Guangzhou, Guangdong Province, China
18 Department of Cardiology, Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
19 College of Textile and Clothing Engineering, Soochow University, Suzhou, Jiangsu Province, China
20 Novaprint Therapeutics Suzhou Co., Ltd, Suzhou, Jiangsu Province, China
21 Tongguang (Kunshan) Biological Technology Co., Ltd., Shanghai, China

Correspondence Address:
Jinwu Wang
Department of Orthopaedic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Room 701, No. 3 Building, 639 Zhizaoju Road, Shanghai 200011
China
Kerong Dai
Department of Orthopaedic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Room 701, No. 3 Building, 639 Zhizaoju Road, Shanghai 200011
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/digm.digm_37_21

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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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