Registration for Foreign Manufacturer
The official name of Korean Competent Authority is MFDS (Ministry of Food & Drug Safety), but most people are calling it with old name, KFDA (Korea Food & Drug Agency), because it is more easy to understand.
The registration procedure differs according to class of the device. KFDA is running 4 step classification system (class 1 to 4), and each product has its predesignated class, like that of US FDA. Every application document shall be prepared in Korean Language and be submitted by registered importer.
In addition to product registration, you need designate registered importer in Korea and have to get KGMP certification.
In Korea, registration holder is importer, not foreign manufacturer. For the foreign manufacturer who want to be registration holder, our company supplies contract registration holder service. For the more information, see the chapter [Registration Holder Service]
Following table shows summary of the procedure.
|Class 1||Class 2
(3rd party review)
|Class 2·3·4 (Approval)||Class 2·3·4 (Approval with Safety & Efficacy Evaluation)|
|TCF Review||Reviewing Agent||N/A||NB (Authorized by KFDA)||National Institute of Safety Evaluation|
|Reviewing Term (Working Days)||N/A||25||55||70|
|Necessity of Testing & Validation Report||X||O||O||O|
|Product Declaration & Approval||Reviewing Agent||Medical Device Data Supporting Center||MFDS|
|Reviewing Term (Working Days)||10||10||10||10|
|Necessity of GMP certificate||X||O||O||O|