Globaluck receives KGMP certification
Announcement: Cortical Dynamics Ltd’s South Korean exclusive
distributor of their Brain Anaesthetic Response Monitoring system,
Globaluck receives KGMP certification
Cortical Dynamics Ltd are pleased to announce, that after a qualified third
party auditor from South Korea audited our manufacturing facility in
Scoresby, Victoria during the month of July 2019; Globaluck, who are the
exclusive distributor of Cortical’s Brain Anaesthesia Monitoring
System(BARM) medical device product in South Korea, received their
KGMP certificate of approval for BARM (Class II Medical Device) from the
Korea Good Manufacturing Practice (KGMP) on the 25 th September 2019.
KGMP certification is required by the Korean Ministry of Food and Drug
Safety (MFDS) before you can place any Class II, III, and IV medical
devices on the South Korean market. To obtain KGMP certification, you
must submit documentation to an MFDS authorized third party auditor,
demonstrating that your device complies with design, risk, technical, and
related KGMP quality system requirements. Following submission of your
KGMP certification application, your manufacturing site will undergo
inspection by a qualified third-party auditor and/or the MFDS depending on
your device’s classification.