A comparative analysis of bioprinting regulation in Europe, the USA and Australia

Nielsen J, Kaldor J, Irwin A, Stewart C and Nicol D | Journal of 3D Printing in Medicine, 5(3) (ePub ahead of print) (2021) Keywords: 3D bioprinting • biologics • governance • medical devices • medicines • regenerative medicine • regulation • tissue engineering Like most health technology innovators, bioprinters are required to traverse a complex landscape featuring varied forms of regulation. This article focuses on one of the most complex aspects: the requirement imposed by regulatory authorities to satisfy them of the safety, efficacy and clinical utility of resultant healthcare products. Satisfaction of such requirements can result in a significant lag...