Advertising and Promotional Claims — MFDS Rules
Medical device advertising in Korea is regulated by the Medical Devices Act and MFDS advertising standards notifications.
General principles
- Claims must be consistent with the approved intended use (품목허가 / 품목신고 scope)
- Claims must not be false, misleading, or exaggerated
- Clinical claims must be supported by evidence in the approved technical documentation
Grade III/IV — MFDS pre-approval of ads
For Grade III and IV devices, general public advertising must be reviewed and approved by MFDS before publication. Advertising to healthcare professionals has lighter requirements.
Prohibited claims
- Efficacy claims beyond the approved intended use
- Superlatives ("best", "most effective") without substantiation
- Comparative claims without approved clinical data
- Claims linking the device to unapproved indications
Relevant legislation
- Medical Devices Act, Article 24 · MFDS Notification — Advertising Standards