Ministry of Food and Drug Safety: Applicant Guide for Preparing for GMP Audits of Patient-Specific Medical Devices Using 3D Printers

The growing number of private or custom industries is increasing rapidly due to the decline and average life expectancy in the United States, Europe, Japan and the average increase in life expectancy, with the growing demand for new technologies and specialized health care systems special to the individual. The era of “corrected medicine” is opening up based on information about personal illness, and it is changing into a future health care paradigm that focuses on predictions, prevention and consumer participation. Consumers are actively engaged in creating the product and service they want, and are undergoing revolutionary changes called the Fourth Industrial Revolution. The change is markedly improved by the rapid production process of medical devices, one of the key technologies of the fourth Industrial Revolution, which is the standard production process for the medical device, which reflects the demand of users and has been dramatically improved in consumer satisfaction and productivity. The manual does not mean that you are approved for food medicine safety, but it is designed to help the manufacturer build and maintain a health care system by providing a consideration for the GSP standard in the manufacture of patient-selected medical devices using 3D printers.

Korean title: 3D프린터를 이용한 환자 맞춤형 의료기기의 GMP심사 준비를 위한 민원인 안내서

Korean author: 식품의약품안전처

Korean publisher: 진한엠앤비

ISBN-13: 9791129002525