Guo Xiao-Lei, Liu Bin, Lu Zhong
Centre for Medical Device Evolution, Beijing, China.
Orthop Surg. 2019 Feb;11(1):10-14. doi: 10.1111/os.12415.
This report aims to summarize key concerns regarding customized devices and conditional approval during the premarket evaluation of bone implants, and to explore the correlation between them. Based on the experience of approval of the first domestic custom-designed bone implant, we consider the process of gaining conditional approval for urgently-needed medical devices and medical devices for rare diseases, as well as the guidance available for clinical investigation. We also streamlined the scientifically administrative concept of this unique device, from the design and development of premarket technical evaluation to continuous post-market study. The present study found that those two aspects have certain connections, but they are not directly correlated to each other. In contrast to the USA, Canada, Australia and the EU, where regulations and guidelines have been established for the use of customized devices, in this regard, China is still it its infancy. Thus, there is considerable potential for China to develop and perfect the policies relating to customized devices and to develop relevant strategies to ensure their efficacy with the aid of conditional approval. Appropriate scientific conditional approval for mass production of individualized anatomy-matching bone implants could become a valuable approach for precision medicine.
本报告旨在总结骨植入物上市前评估期间有关定制器械和有条件批准的关键问题，并探讨它们之间的相关性。基于国内首个定制设计骨植入物的获批经验，我们考量了急需医疗器械和罕见病医疗器械获得有条件批准的过程以及临床研究可用的指导原则。我们还简化了这种独特器械的科学管理理念，从上市前技术评估的设计与开发到上市后持续研究。本研究发现，这两个方面存在一定联系，但并非直接相关。与美国、加拿大、澳大利亚和欧盟已针对定制器械的使用制定法规和指南不同，在这方面，中国仍处于起步阶段。因此，中国在制定和完善与定制器械相关的政策以及借助有条件批准制定确保其有效性的相关策略方面具有相当大的潜力。对个体化解剖匹配骨植入物进行大规模生产给予适当的科学有条件批准，可能成为精准医疗的一种有价值方法。
