Korea MFDS Regulation on Advertising - only to Healthcare professional

[Deeep]

Hi Team,

I'm a little confused about the advertising regulations for medical devices in Korea by MFDS. I understand that medical device advertising cannot display doctors or nurses, but what about medical devices that are only intended for use by doctors and nurses?

If we manufacture a medical device that is only intended for doctors, can we use doctors as models in the advertising? If not, then can we not use non-doctors, as this product is not intended for them? What are the options we have, does anyone have any experience with this?

Thanks

 

[Hyeoncheol Hong]

It sound interesting. Based on my searching, if the devices are intended for experts only, experts may can be appear in advertisements, but the appearance of experts cannot imply or claim that the device is effective or any prohibition by regulations. Experts in advertisements are only shown in simple form of using the device.

It's been a while since you asked this question, but I hope this answer helps.

 

[Deeep]

Thank you so much, Hyeoncheol. If it's not too much trouble, would you please forward a link to your research? I totally agree with you .

 

[Hyeoncheol Hong]

Thank you so much, Hyeoncheol. If it's not too much trouble, would you please forward a link to your research? I totally agree with you .

Dear,

I'm glad to hearing from you that my comment was helpful.
Unfortunately, I can't share the link due to the Spam prevent policy of the Forum.
Also, I can't find an English version of this document too.

For your reference, the applicable regulations for these issues are written in the page 36 of the <Medical Device Advertisement Guide, MFDS>
and I shared the regulation as below. (Since it was written in Korean, I shared it using a translator.)

「If the advertisement displays or implies the face and name of a medical professional or the name of a medical institution, it may cause confusion to consumers as they may mistakenly believe that it guarantees the performance and efficacy/effect of the medical device. Therefore, it cannot be used.」

「However, in advertisements for medical devices used only by medical professionals, such as MRI, CT, and robotic surgical devices, expressions may be used for advertising as long as they do not expose specific medical professionals or medical institutions or imply that it guarantees the performance and efficacy/effect of the medical device.」

「To explain the performance of imaging diagnostic equipment used by medical professionals, it is possible to use images to simply compare whether functions are applied.」

Thanks.