Hot on the heels of US FDA’s new guidances on 3D printing, the Korea MFDS has indicated its intention to allow fast track regulatory approvals for 3D printed devices for humanitarian cases and to introduce new more comprehensive regulations for 3D printed devices by November 2016.
In an inter-ministerial meeting on deregulation in Seoul in May, 3D printed devices were identified as a priority for deregulation. This is in line with a national strategy developed in 2014 to support the development of 3D printing as a strategic technology.
There is no written announcement as yet. The MFDS pronouncements have been via statements at symposiums and in the press in Korea. MFDS statements have indicated
However, commercial priorities notwithstanding, the MFDS is taking a cautious approach. Speaking to the Korea Times, MFDS official Lee Sung Hui noted that MFDS would “…be looking into any potential negative side effects for fast-track use in coordination with medical professionals and agencies.”
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