SEOUL, Jan. 10 (Korea Bizwire) – The South Korean Ministry of Food and Drug Safety (MFDS) has announced that clinical trials for low-risk medical devices, including medical artificial intelligence (AI), can now be conducted without the need for clinical plan approval from the MFDS. This change will also allow trials to be conducted outside of designated [...]
SEOUL, Sept. 18 (Korea Bizwire) – The recent series of court rulings recognizing the use of ultrasound and electroencephalogram (EEG) diagnostic devices by Doctors of Korean Medicine (or Korean Medicine Doctor (KMD)) has reignited the ongoing dispute between KMDs and conventional medical doctors. This conflict has escalated to a critical point, exacerbated by the issue of [...]
SEOUL, July 10 (Korea Bizwire) — The government has announced plans to significantly strengthen the safety management of medical devices that are implanted into human bodies. A new system will be set up to track medical implants from factory release until the surgical implant procedure. The Ministry of Food and Drug Safety announced on Thursday [...]
GWANGJU, July 8 (Korea Bizwire) — A new technology has been developed in South Korea to supply power to implanted healthcare devices via a light-emitting diode (LED) patch that uses light as a medium for power supply. A research team led by Lee Jong-ho, professor of mechanical engineering at the Gwangju Institute of Science and [...]
SEOUL, Feb. 27 (Korea Bizwire) – By October at the latest, the Ministry of Food and Drug Safety plans to revise the Medical Devices Act so that medical devices purchasable by consumers are henceforth required to be sold with prices on display. The reason necessitating the price display scheme is the continual harm suffered by [...]
SEOUL, Apr. 3 (Korea Bizwire) — South Korea’s science ministry said Sunday that it will spend 41.2 billion won (US$37 million) this year to develop core 3D printing expertise to nurture the fledging industry. The 2017 budget will be spent on various 3D printing businesses to spur demand and strengthen national competitiveness, the Ministry of [...]
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 [...]