MFDS Registration
Crack the Code of Korean Compliance.
Navigate the MFDS maze with a local partner. From Class I notification to complex Class IV approvals, we execute a **Local Strategy** tailored to Korean reviewers' specific tastes.
The Challenge
Substantive Equivalence
?앹빟泥??ъ궗???듭떖??'湲고뿀媛 ?쒗뭹怨쇱쓽 ?숇벑??鍮꾧탳??瑜??ъ궗愿???덈넂?댁뿉 留욎떠 ?꾨꼍?섍쾶 ?묒꽦?⑸땲??
Testing Coordination
?쒓뎅 ???쒗뿕 寃??KTL, KTC ?? ?쇱젙??吏곸젒 議곗쑉?섍퀬, ?쒗뿕 ?ㅻ쪟瑜?諛⑹??섍린 ?꾪븳 湲곗닠 吏?먯쓣 ?쒓났?⑸땲??
KGMP Alignment
?덇?? ?숈떆???꾩닔?곸씤 KGMP ?ъ궗 ?쇱젙???곌퀎 愿由ы븯?? ?덇?利??섎졊怨??숈떆???먮ℓ媛 媛?ν븯?꾨줉 ?⑸땲??
Frequently Asked Questions
?댁쇅 ?쒗뿕 ?깆쟻?쒕룄 ?몄젙?섎굹??
Generally yes (ILAC certified), but specific tests like Biocompatibility often require re-formatting or local bridging.
?뚯슂 湲곌컙? ?쇰쭏???섎굹??
Class II takes 3-4 months; Class III/IV takes 6-8 months (excluding stop-clock time).
?꾩긽 ?쒗뿕 ?먮즺媛 ?놁쑝硫??덇?媛 ???섎굹??
If a predicate exists, you can likely skip clinicals via "Substantial Equivalence."