Global Representation & Importer Services
Your Official Regulatory Bridge to Korea, US, and EU.
The 'Distributor Trap'
The biggest mistake foreign manufacturers make is letting their sales distributor hold their regulatory license, especially in restricted markets like Korea. This creates commercial lock-in and serious compliance risks.
Loss of Control (Lock-in)
If you change distributors, they may refuse to transfer the license for your device, forcing a costly and time-consuming re-registration process.
Conflict of Interest
Distributors are focused on sales. They may hide or downplay customer complaints and adverse events to protect their numbers, putting you at risk.
Audit Panic
When regulators show up for an inspection (e.g., KGMP audit), a sales-focused distributor is rarely equipped to manage the process effectively.
The Leanabl Insight
Regulatory independence is strategic freedom. Separating the roles of 'Sales' and 'Compliance' allows you to switch distributors at any time without disrupting your market access, giving you ultimate commercial flexibility.
Tailored Roles for Each Market
We provide the specific legal entity required by law in each region, acting as your independent regulatory partner and ensuring your interests are always protected.
Korea: License Holder & Importer
We act as your In-Country Caretaker (ICC), managing KGMP compliance, importation, mandatory QC testing, and serving as your official regulatory liaison.
USA: US Agent
As your official point of contact for the FDA, we handle all formal communications and provide crucial support during any potential agency inspections.
Europe: EU Authorized Representative
We serve as your legal representative within the EU, interfacing with Competent Authorities, managing EUDAMED registrations, and handling vigilance reporting.
More Than Just a Name on a Label
Appointment & Agreement
We execute the legal agreements to formally establish Leanabl as your representative in your target markets.
Registration & Labeling
Our team handles all necessary device registrations and ensures your product labeling correctly reflects our local address and role.
Ongoing Vigilance
We provide 24/7 adverse event reporting and management, ensuring timely and compliant communication with regulatory bodies.
Your Complete Service Package
Local Address & License
Customs Clearance (Korea)
Management of customs (CCSC) and lot release testing.
Vigilance Reporting
24/7 adverse event handling and reporting.
Why Choose Independent Representation?
Korea Specialist
We are direct experts in Korea's unique MFDS regulations, handling the heavy lifting of importation, KGMP compliance, and QC testing that generalist firms can't.
Commercial Neutrality
We do not sell devices. This eliminates any conflict of interest, ensuring our actions are always aligned with your compliance needs and long-term business strategy.
One Partner, Three Markets
Simplify your vendor management by using Leanabl as your single, trusted representative across Korea, the United States, and the European Union.
Protect Your License. Expand Freely.
Don't lock your business into a single distributor. Choose independent, professional representation to secure your market access.
Appoint Leanabl as My Rep