KFDA, the Korea Food and Drug Administration regulates all medical devices under Korea’s Medical Device Act. All medical devices require pre-market registration from KFDA and must meet Korean Good Manufacturing Practice (KGMP) before they can be imported or manufactured in Korea.
 
Medical devices are classified as class I, II, III or IV while there are separate regulations for IVDs. Foreign manufacturers without an office in Korea may apply for registration with the KFDA only through their importer or an independent third party. Medical device registered in South Korea requires the following: a device business license, a product license and a certificate of Korean Good Manufacturing Practice (KGMP). Our country specific (*) regulatory services in South Korea include:
 
Medical Device specific regulation strategy reports, Medical Device Registration with KFDA, KFDA Technical documents Preparation, license holder and local Authorize Representative, Compliance with KGMP requirements and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.
 
GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill the following form, submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in South Korea!

(*) South Korean Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.