International Sponsor Program
U.S. Agent, official correspondent, IDE Sponsor of Record, and FDA submission support for South Korean device manufacturers entering the U.S. market.
South Korea's Ministry of Food and Drug Safety (MFDS) regulates medical devices domestically, and MFDS approval or KGMP (Korea Good Manufacturing Practice) certification is often the first regulatory milestone a Korean manufacturer reaches. MFDS clearance informs a U.S. FDA strategy — shared test data and clinical experience can shorten the U.S. gap analysis — but it does not substitute for FDA's own review; a device cleared by MFDS still needs its own FDA pathway determination, predicate analysis, and submission.
The questions that come up most often from Korean manufacturers center on how much of their existing clinical and bench data from a Korean or regional study can carry into a U.S. submission, whether an Early Feasibility Study is the right entry point for a genuinely novel implantable device, and whether a device qualifies for Breakthrough Device Designation given the clinical problem it addresses. Each of these is a Pre-Submission-stage conversation with FDA, not a question with a universal answer — the right path depends on the specific device and data package.
A Korean manufacturer distributing devices commercially in the U.S. needs a U.S. Agent under 21 CFR 807.40 before FDA establishment registration can complete, and a reachable official correspondent for ongoing FDA correspondence. ADB serves both roles, with all FDA correspondence logged and handled by the practice director of record.
Korea Standard Time runs roughly 13-14 hours ahead of U.S. Eastern Time, which puts a Korean team's evening into a U.S. Eastern morning — a natural overlap window for scheduled calls. Outside that window, written correspondence through the client portal keeps the program moving without requiring every update to happen live.
Korean manufacturers most often bring ADB cardiovascular and structural heart devices, aesthetic and energy-based devices, dental devices, and digital health software — these are areas ADB has supported or is equipped to support, not an exhaustive or exclusive list.
Common Questions
MFDS approval and supporting data can inform the U.S. gap analysis and may reduce incremental testing needs, but FDA conducts its own independent review — MFDS clearance is not a substitute for an FDA predicate analysis, submission, and decision.
FDA requires a U.S.-based sponsor contact for a U.S. IDE study. A Korean manufacturer typically engages a U.S. Sponsor of Record under 21 CFR Part 812 to take on that role rather than acting as its own U.S. sponsor directly.
Establishment details for FURLS registration, device listing information including product code, and a signed U.S. Agent designation. ADB handles the FURLS submission and ongoing FDA correspondence from there.
It can be, if the device treats or diagnoses a life-threatening or irreversibly debilitating condition and meets one of the second-criterion pathways (no approved alternative, breakthrough technology, significant advantage, or patient-availability interest). The request is evaluated on the device’s own merits regardless of where it was developed.
Get Started
30 minutes to assess your U.S. Agent, submission, or IDE sponsor needs.