Sun Jiayi, Wu Jing, Qian Hong, Liu Bin, Zhang Shiqing
Center for Medical Device Evaluation, CFDA, Beijing, 100081.
Center for Certification & Evaluation, SHFDA, Shanghai, 200020.
Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Nov 30;41(6):432-435. doi: 10.3969/j.issn.1671-7104.2017.06.011.
Customized medical devices differentiate in product design, manufacturing, usage, and a few other aspects in the product's life cycle. Customized medical devices should have special regulatory requirements. Through introducing the relevant regulations, policy and control measures for customized medical devices in different countries, this article intends to summarize the common characteristics of customized devices. Also, considering the development of fixed denture and medical device regulations in China, we aim to provide reference for investigators by discussing regulatory categorization in the definition and management, quality system, clinical evaluation and the post-marketing use of customized medical devices in our country.
定制化医疗器械在产品设计、制造、使用以及产品生命周期的其他一些方面存在差异。定制化医疗器械应有特殊的监管要求。通过介绍不同国家定制化医疗器械的相关法规、政策及管控措施，本文旨在总结定制化器械的共同特征。此外，结合我国固定义齿及医疗器械法规的发展情况，我们旨在通过讨论我国定制化医疗器械在定义与管理、质量体系、临床评价及上市后使用方面的监管分类，为研究者提供参考。
