Every Marketing Claim Your Korean Partners Make Is Your Regulatory Responsibility.
Unlicensed promotional claims by your distributor can result in your product being delisted.
Korea requires pre-approval from MFDS-designated bodies for all medical device promotional materials that make specific clinical or performance claims. Many foreign manufacturers are unaware that their distributors' sales decks, social media posts, or website content may require this approval. A violation doesn't just penalize the distributor — it can result in sanctions against the product license itself.
A Structured Promotional Review and Submission Service.
Leanabl reviews every promotional material against MFDS advertising guidelines, identifies claims requiring pre-approval, and manages the official submission process on your behalf. We also advise your Korean partners on compliant messaging to minimize future review cycles.
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.
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.
What You Receive
Leanabl delivers a structured, audit-ready promotional review record that protects the license holder from enforcement actions related to advertising violations.
- 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
Protect Your License — Not Just Your Brand.
Promotional non-compliance in Korea is not a marketing issue — it's a regulatory one. A single unapproved claim, if flagged by MFDS or a competitor complaint, can trigger a formal investigation of your product license. Leanabl's promotional review service converts advertising compliance from a reactive legal risk into a proactive, managed process.
Submit Your Promotional Materials for ReviewFrequently Asked Questions
Common questions about Korean medical device advertising regulations and Leanabl's promotional review service.