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Issues confronted with biomaterials research and development and market access in craniomaxillofacial field

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Author:: No author available

Journal Title:: Chinese Journal of Stomatology

Issue:: 11

DOI:: 10.3760/cma.j.issn.1002-0098.2016.11.001

Key Word:: 生物相容性材料;临床试验;质量控制;Biocompatible materials;Clinical trial;Quality control

Abstract： There are a variety of biomedical materials applied in craniomaxillofacial and dental clinical practice,plastic surgery,otorhinolaryngology and neurosurgery.With the increasing investment for the biomedical materials study,considerable progress has been obtained in biomaterials research.But overall,the field of biomaterials in China is still in a backward state.The development of advanced manufacturing technology has put forward new demands for the research of biological materials and has expanded the application,but at present,there are few biomaterials that meet the requirements.The further development of three-dimensional printing technology is beneficial to the preparation of the craniofacial personalized prosthesis,but biomaterials and instruments for clinical use must be accorded with corresponding regulation.To carry out clinical trials,the application must be submited to the Food and Drug Administration Department of the State Council for registration.

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