Korean regulatory requirements are administratively and legally complex and they can be difficult to navigate through. Manufacturers of class 2, 3 and 4 devices must receive K-GMP ( Korean Good Manufacturing Practices ) Certification prior to issuance of the device registration, and renew every 3 years, and also require supplementary testing to Korean product standards as part of the registration. With in-depth knowledge of local regulatory services and interaction with health authorities, our regulatory staff is well experienced and has been with the company for more than 15 years on average.