The Ministry of Food and Drug Safety of Korea ("MFDS") announced recently on November 14, 2022 that it has strengthened its regulations and enforcement on product advertising/marketing of medical devices using un-approved/authorized clinical trial results.  

Please note that the Medical Device Act ("MDA") of Korea already prohibits advertisement/marketing of unapproved medical devices or functions of medical devices under Article 24 and Article 45 of Enforcement Decree of the MDA.  However, as the market for medical devices has grown rapidly as of late, marketing/advertisements using results of clinical trials have increased in the Korean market.  The MFDS announced that it has implemented these recent regulations in order to prevent the misunderstanding and mis-use of medical devices by consumers/customers.  

If medical device companies violate the new regulations, it can lead to administrative sanctions or even criminal referral.  Please feel free to reach out to MDREX at (pro@mdrex.co.kr) if you have any questions or inquiries regarding this new regulation by the MFDS or if you have any inquires on medical device regulations in the Korean market in general.