SEOUL, May 23 (Korea Bizwire) – The Ministry of Food and Drug Safety is hoping to change regulations by November to allow the limited use of medical instruments manufactured from 3D printers before they receive final government approval, officials said on Monday.
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, citing the benefits of 3D printers such as guaranteed precision, convenience, and speed.
Officials said the use would most likely be limited to treating patients who have run out of other available means of treatment or cures, citing artificial joints and dental prosthesis as possible applications. South Korea drew up a state-supported policy to develop the 3D printing industry in 2014.
“It would greatly help patients who have no other alternative means of treatment because of their physiological or pathological characteristics,” said Sung Hui Lee, a working-level official at the ministry who handles oral and digestive issues. “We will be looking into any potential negative side effects for fast-track use in coordination with medical professionals and agencies,” he added.
Ministry officials said they plan to complete regulations, revisions and announcements by November and then expedite the commercialization process.
By M. H. Lee (firstname.lastname@example.org)