Balancing the customization and standardization: exploration and layout surrounding the regulation of the growing field of 3D-printed medical devices in China.

Abstract

Medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment, playing an indispensable role in modern medicine. Nowadays, the increasing demand for personalized medical devices poses a significant challenge to traditional manufacturing methods. The emerging manufacturing technology of three-dimensional (3D) printing as an alternative has shown exciting applications in the medical field and is an ideal method for manufacturing such personalized medical devices with complex structures. However, the application of this new technology has also brought new risks to medical devices, making 3D-printed devices face severe challenges due to insufficient regulation and the lack of standards to provide guidance to the industry. This review aims to summarize the current regulatory landscape and existing research on the standardization of 3D-printed medical devices in China, and provide ideas to address these challenges. We focus on the aspects concerned by the regulatory authorities in 3D-printed medical devices, highlighting the quality system of such devices, and discuss the guidelines that manufacturers should follow, as well as the current limitations and the feasible path of regulation and standardization work based on this perspective. The key points of the whole process quality control, performance evaluation methods and the concept of whole life cycle management of 3D-printed medical devices are emphasized. Furthermore, the significance of regulation and standardization is pointed out. Finally, aspects worthy of attention and future perspectives in this field are discussed.