MFDS(Ministry of Food & Drug Safety) is Korean public institution similar to the US FDA. Most people in Korea refer to MFDS as old name, KFDA(Korea Food & Drug Agency). KFDA classifies medical device into the following class 1 to 4 according to purpose of use and degree of potential risk.

Class 1

Medical device with little potential risk

Class 2

Medical device with low potential risk

Class 3

Medical device with medium potential risk

Class 4

Medical device with high potential risk

MIn order for companies to enter medical device in Korean market, the medical device must be registered with KFDA after evaluation of safety and effectiveness. In addition, an importer must be in Korea, and the importer must obtain KGMP certification.

COSMO21 offers KFDA registration, KGMP certification consulting service at competitive fees. With accumulated experience, we can provide expert advice on all regulatory requirements for medical device.