The Ministry of Food and Drug Safety (MFDS) said on Monday that it will promote international cooperation for the Korean medical device sector at the Global Harmonization Working Party (GHWP) in Riyadh, Saudi Arabia from Monday to Thursday this week.

The GHWP is a cooperative organization established in 1996 to harmonize international regulations on medical devices. There are currently 32 participating member countries around the world, including the U.S. and Singapore, and South Korea has served as chair from 2015 to 2017.

The MFDS is working as vice chair of the International Medical Device Regulatory Harmonization Conference's technical committee and chair of the working group to help domestic innovative products enter the global market.

However, the Korean regulator plans to seek a second term as chair of the General Medical Device Licensing Working Group of the GHWP to actively promote Korean guidelines internationally.

“If domestic guidelines become common international guidelines, we expect that products licensed in Korea will meet international standards and can be exported more smoothly,” said an MFDS official. “Six of our guidelines established have already been adopted by the GHWP.”

In this regard, the MFDS is promoting a global, partner, supporter (GPS) export strategy which entails being recognized as a global leader by the World Health Organization (WHO), partnering to establish and head the Asia Pacific Food Regulatory Agency Authority Summit (APFRAS) and being a strategic export supporter through different projects so excellent domestic products can spread globally.

The Korean regulator is expected to introduce cases of regulatory innovation in the digital health sector as well as guidelines for digital treatment devices, and artificial intelligence (AI).

In particular, the MFDS will propose to adopt the "Artificial Intelligence-Based Histopathology In vitro Diagnostic Medical Device Software Guidelines" as a common international guideline at the meeting.

“We plan to hold bilateral cooperation meetings with members from the International Medical Device Regulators Forum (IMDRF) member countries such as the United States and Europe as well as GHWP member countries to promote Korea's advanced regulations and seek cooperation in digital health, artificial intelligence, and in vitro diagnostic medical devices,” said an MFDS official.