摘要
3D打印技术是一项极具发展潜力的新兴技术,具有个性化定制的特点,使其在医疗器械定制领域发展迅速,3D打印技术也渐渐成为全球研究热点。但是,由于3D打印与传统制造业不同,目前仍然缺乏有关法律法规来规范。各个国家目前都在积极探索制定相关法律法规对3D打印以及其在医疗器械领域应用进行规范。本文针对3D打印医疗器械在中国及其他国家已经公布的法律法规进行总结,展望3D打印技术的未来发展。
3 D printing is an emerging technology with great development potential.With the characteristics of personalized customization,it has developed rapidly in the field of medical device customization.3 D printing technology has gradually become a global research hotspot.Due to the difference between 3 D printing and traditional manufacturing industry,there is still a lack of relevant laws and regulations to regulate it.At present,all countries are actively exploring the development of relevant laws and regulations to standardize 3 D printing and its application in the field of medical devices.This paper summarizes the laws and regulations of 3 D printing medical devices published in China and other countries,and looks forward to the future development of 3 D printing technology.
作者
张文芳
牟洪利
邝晓盈
罗慧妍
杨帆
黄思玉
ZHANG Wenfang;MOU Hongli;KUANG Xiaoying;LUO Huiyan;YANG Fan;HUANG Siyu(New Drug Development Center,Guangdong Pharmaceutical University,Guangzhou 510006,China;Guangdong Provincial Local Precision Drug Delivery Preparation Engineering Technology Research Center;Guangdong Key Laboratory of New Dosage Forms of Drugs,Guangdong Pharmaceutical University,Guangzhou 510006,China;College of Pharmacy,Guangdong Pharmaceutical University,Guangzhou 510006,China;College of Foreign Languages,Guangdong Pharmaceutical University,Guangzhou 510006,China)
出处
《广东药科大学学报》
CAS
2021年第2期157-159,166,共4页
Journal of Guangdong Pharmaceutical University
基金
广州市民生科技攻关计划项目(201903010002)
广州市产学研协同创新重大专项项目(20170402199)。
关键词
3D打印
医疗器械
法律法规
3D printing
medical devices
laws and regulations
