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Government to try fast-track approval for 3D-printed medical instruments

The Ministry of Food and Drug Safety is looking at the possibility of allowing limited use of medical instruments made through 3D printers before final government approval, hoping to change relevant regulations by November, officials said Monday.

The attempt falls in line with the results from an inter-ministerial deregulation meeting last week where 3D-printed medical instruments were specified as a subject of eased restrictions.

The ministry mentioned through public symposiums that it is considering "fast-track approval" for such instruments, which would allow their one-time use in emergencies even before the government approves their medical applications.

Officials said the use would most likely be limited to treating patients who have run out of other available means of treatment or cures. They cite artificial joints and dental prosthesis as possible applications.

Korea drew up a state-supported policy of developing the 3D printing industry in 2014.  Ministry officials say 3D printers guarantee precision, convenience and speed, making them perfect for broad use in the medical field.

"It would greatly help patients who have no other alternative means of treatment because of their physiological or pathological characteristics," Lee Sung-hui, a working-level official at the ministry handling oral and digestive issues, said. "We will be looking into any potential negative side effects for fast-track use in coordination with medical professionals and agencies."

Ministry officials said they plan to complete regulations, revisions and announcements by November, and then expedite the commercialization process. (Yonhap)


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