Analysis of Technical Evaluation for Current Regulation of 3D Printed Customized Medical Device.
10.3969/j.issn.1671-7104.2018.04.014
- Author:
Zhijin FAN
1
;
Neng XIE
1
Author Information
1. Center for Certification & Evaluation, Shanghai Food and Drug Administration, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
3D print;
3D printed customized medical devices;
European Union;
FDA;
regulations
- MeSH:
Equipment and Supplies;
European Union;
Printing, Three-Dimensional;
United States
- From:
Chinese Journal of Medical Instrumentation
2018;42(4):279-281
- CountryChina
- Language:Chinese
-
Abstract:
This paper summarizes the current research status of 3D printed customized medical devices regulations in US and EU. Based on the discussion of 3D printed customized medical devices in the US and the European Union, some thoughts are put forward from design, manufacturing, testing and other aspects.
