Dear friends! RITM OKB ZAO now has the KGMP certificate for South Korea!
One major step for companies registering medical devices in South Korea is compliance with the Korea Good Manufacturing Practice (KGMP) quality system regulations. Similar to ISO 13485 quality system standards, KGMP is required by the Korean Ministry of Food and Drug Safety (MFDS) for all Class II, III, and IV medical devices.
MFDS takes great responsibility in verifying medical devices for regulatory compliance. The complete process includes the examination of the manufacturer’s Quality Management System standards, as well as submited product technical documentation. In case of their compliance with all the requirements, the MFDS will proceed with the onsite inspections. We are proud to say that RITM OKB ZAO and our products fully comply with the high requirements of the KGMP standards. We have once again confirmed that RITM OKB ZAO’s products can be freely used and distributed in South Korea.
Earlier we informed that the Department of Neurosurgery, CHA Bundang Medical Center, CHA University, Seongnam, Korea has conducted a research comparing the efficiency of SCENAR and TENS devices(See here:https://scenar.com.ru/en/news/158-scenar-was-recognised-better-than-tens-in-south-korea.html ). This randomized placebo-controlled prospective study was conducted in 60 patients with neck pain following rear-end collision. The results evidenced that SCENAR therapy provided a significant reduction in the intensity of neck pain (VAS) and disability (NDI) compared with TENS group, which makes it possible to state that SCENAR therapy is superior to the TENS therapy in reducing pain and disability for whiplash injury.