US FDA and Korean Ministry of Food and Drug Safety (MFDS) Agree to Work Together on Medical AI Products

Last month, officials from Korea and the US issued a Memorandum of Cooperation (MoC) on AI used in medical and healthcare products. According to the MoC, the two countries will try and harmonize regulations on AI medical products. The Korean government also plans to reach out to other advanced countries to discuss how to harmonize and register more efficiently other digital technologies including cloud computing. Hopefully, such convergence will help get these new medical technologies approved more quickly in the Asian markets for the benefit of each country’s local population.

In a similar effort, Korea’s MoHW is now wanting to make telemedicine permanent. In 2020 with the onset of the COVID pandemic, Korea allowed telemedicine for the first time on a temporary basis. During this trial period, elderly people and people with chronic illnesses and COVID were dramatically helped in Korea. The telemedicine program was very successful, which has strongly influenced Korea’s MoHW.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.