In Korea, New Self-Regulatory Review System for Medical Device Ads Begins to Take Shape

Two months after Korea announced a new system that puts private review boards in charge of ensuring that advertisements for medical devices in Korea adhere to government standards, the scope of the reviews and details of the application process is beginning to become clear.


Under the new system, all advertisements for medical devices that impact the human body are subject to review. Applications for approval of advertisements must be submitted online through a self-regulatory review body, then followed by online or in-person reviews. Approvals will be valid for three years.


The private review board system is the result of a ruling by Korea’s highest court in 2020 that it is unconstitutional for the government to require preliminary approval of advertisements for medical devices. As a workaround, the Ministry of Food and Drug Safety (MFDS) announced that private review boards will review ads going forward and report their findings to the Ministry. To date, the only organization that has registered to conduct the private reviews is the Korea Medical Devices Industry Association (KMDIA).


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 the 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.