Advertising and Promotional Claims โ MFDS Rules
Medical device advertising in Korea is regulated by the Medical Devices Act and MFDS advertising standards notifications.
General principlesโ
- Claims must be consistent with the approved intended use (ํ๋ชฉํ๊ฐ / ํ๋ชฉ์ ๊ณ scope)
- Claims must not be false, misleading, or exaggerated
- Clinical claims must be supported by evidence in the approved technical documentation
Grade III/IV โ MFDS pre-approval of adsโ
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 claimsโ
- 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 legislationโ
- Medical Devices Act, Article 24 ยท MFDS Notification โ Advertising Standards