After Court decision, Korea Dismantles System for Regulating Medical Device Advertisements – Puts Onus for Compliance on Private Industry Review Boards

Almost a year after Korea’s highest court ruled it unconstitutional for the government to require preliminary approval of advertisements for medical devices, the Ministry of Food and Drug Safety (MFDS) has announced that private review boards will review ads going forward and report their findings to the Ministry.

The new system makes the private review boards responsible for monitoring compliance with government standards, and for reporting violations to the MFDS. The review bodies may be established by private medical device-related organizations registered with the Korea Fair Trade Commission. To date, the only organization that has registered to conduct the private reviews is the Korea Medical Devices Industry Association (KMDIA).

The workaround is designed to ensure that advertisements for medical devices adhere to government standards while still complying with the letter of the August 2020 decision by Korea’s Constitutional Court. The court ruled that requiring prior approval by the government of advertisements is unconstitutional. Previous to the court’s ruling, prior government approval was required of advertisements in mass media such as daily newspapers distributed in print and on the Internet, television or radio. Under the new private review system, the scope of review will also include ads displayed on electronic signboards, billboards, posters, flyers, and over a wide swath of the Internet, including homepages of broadcasting companies and on social media platforms.