The South Korean Ministry of Food and Drug Safety released improved guidelines for 3-D printed medical devices Friday, with aims to spur the growth of the emerging business segment.
The ministry’s new guidelines establish more concrete and detailed regulatory standards for conducting product efficacy, safety and biocompatibility testing for 3-D printed implants for bone fixtures and dental surgery.
The Ministry of Food and Drug Safety (Yonhap)
In improving its guidelines, the ministry aims to encourage more companies to develop and commercialize more safe and efficient 3-D printed medical devices, it said.
Currently, only 18 3-D printed medical products from 10 companies — including surgical implants and markers used during bone fixture surgeries — have been approved here, according to the ministry.
Next month, the ministry plans to newly introduce guidelines for creating artificial cartilage, blood vessels and skin using 3-D printing technology.
The information can be viewed by visiting the Korean website of www.mfds.go.kr and clicking on the “Regulations & Information” tab and the “guidelines” category.
By Sohn Ji-young (jys@heraldcorp.com)
