The Ministry of Food and Drug Safety and the U.S. Food and Drug Administration concluded a memorandum of cooperation (MOC) on medical products based on artificial intelligence last Thursday (local time).
According to the Korean regulator on Tuesday, Minister Oh Yu-kyoung and Commissioner Robert M. Califf signed the MOC and discussed ways to cooperate in digital health between the two organizations.
The MOC was part of the strengthening cooperation between Korea-U.S. in high-technology areas, backing up cooperation in core and new technology as the South Korean and U.S. leaders agreed on. It was also a follow-up to the talks between Minister Oh and Commissioner Califf in March.
More specifically, the MOC aims to share experiences of using AI to develop medical products, promote innovative technology to develop effective and safe medical products and harmonize regulations on medical products using AI under the joint initiatives of the Korean and U.S. food and drug regulators.
The ministry explained that in the borderless digital era based on cloud computing, regulatory agencies in major countries agreed on the need for internationally harmonizing regulatory systems to hasten the development of medical products using AI and using them in medical fields quickly.
Against this backdrop, the ministry also evaluated that the MOC signing was significant in that the two organizations recognized the importance of international regulatory harmonization in the digital health area and took their first joint step to discuss and worry about such issues so that they could reinvigorate the development of AI-based medical products.
The Korean ministry plans to conduct a joint workshop to share AI-using experiences with various foreign regulatory agencies and support the development of safer and more effective medical products more quickly using innovative digital technology.
Last Wednesday (local time), Minister Oh also visited WellDoc. This U.S. company won approval for digital treatment devices for the first time worldwide, sharing opinions on the recent global trend in digital healthcare and the direction of its future development.
“The government will continue and develop in-depth discussion with the FDA based on the joint workshop and try to make it used as a global standard,” the ministry said. “It also will streamline related systems based on it and work out guidelines in a preemptive manner, strengthening regulatory support for developing and exporting AI-based medical products.”