May 23, 2016 | By Alec

It looks like the South Korean government firmly believes in the power of 3D printing. Over the past few months, the South Korean military has already adopted metal 3D printing for airplane parts, while the government recently unveiled plans for a $20 million 3D printed ship project. But even the country’s medical sector is set to benefit from 3D printing, as the South Korean government revealed that they are looking into fast-track approval options for 3D printed medical instruments and devices.

This announcement has just been made by officials from the South Korean Ministry of Food and Drug Safety. In particular, they are looking to change regulations to enable 3D printed medical instruments to be used in hospitals as quickly as possible, even before final government approval has been granted. These plans have grown out of a recent inter-ministerial deregulation meeting, which specified that 3D printed medical instruments should not be subjected to the same restrictions as conventional instruments.

The officials explained that custom 3D printed instruments, from artificial joints and dentures to prosthetics, are developed to be used in very specific cases. Such instruments should be usable in the (life-threatening) emergencies they are intended for, even if they are not officially approved for use yet. Especially when no other treatment methods or cures are available, a fast-track approval system should make one-time uses possible.

While such measures could make insurance processes far more complicated, it would certainly enable surgeons and specialists to use 3D printers to their full potential. Qualifying 3D printed parts is, due to their uniqueness, still one of the biggest obstacles preventing large-scale adoption of 3D printing.

But the technology is, the officials argued, perfect for broad use in the medical field thanks to its production speed, precision and customizability. “It would greatly help patients who have no other alternative means of treatment because of their physiological or pathological characteristics,” said Lee Sung-hui, a ministry official. “We will be looking into any potential negative side effects for fast-track use in coordination with medical professionals and agencies.” The officials further said that they expect to complete their regulation revisions by November of this year.



Posted in 3D Printing Application



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