Regulatory Claim Screening
We evaluate each promotional material against the Korean Medical Devices Act and MFDS advertising guidelines to identify claims that require formal pre-approval before distribution.
Promotional Review
Every Marketing Claim Your Korean Partners Make Is Your Regulatory Responsibility.
Unlicensed promotional claims by your distributor can result in your product being delisted.
Official Pre-Approval Submission
We prepare and submit promotional materials to the designated MFDS review body, manage the approval process, and obtain the official approval certificate required for lawful distribution.
Compliant Messaging Guidance
Where materials do not meet approval requirements, we provide specific revision guidance to your distributors and marketing teams, reducing rework cycles and accelerating time-to-market.
Service specification
Korea Promotional Review
Leanabl delivers a structured, audit-ready promotional review record that protects the license holder from enforcement actions related to advertising violations.
Request assessmentKorea requires pre-approval for medical device promotional materials with clinical or performance claims. Distributor sales decks, social posts, and websites all count — and violations sanction the product license itself.
Regulatory Review Checklist for each submitted material
Official MFDS Pre-Approval Certificate for approved promotional materials
Revision Guidance Memo for materials requiring modification
Promotional Material Archive with approval status tracking
Korean Advertising Compliance Guide for your distributor network
Frequently Asked Questions
Common questions about Korean medical device advertising regulations and Leanabl's promotional review service.