South Korea Seeks To Lead Global Regulation On Medical AI

The Ministry of Food and Drug Safety has set about to become an advanced regulatory agency for artificial intelligence-based medical devices.

The ministry said it hosted the regular meeting of the Artificial Intelligence Working Group within the International Medical Device Regulators’ Forum (IMDRF) from Thursday to Saturday.

Read more: AI In Medical Regulations 2022: Intensifying Need To Handle Complex Datasets

IMDRF is a consultative body of regulatory authorities formed to harmonize and unify international regulations on medical devices throughout the entire cycle before and after their development and commercialization. Eleven countries, including the US and EU, are participating in it. Korea served as a chair country last year.

According to the ministry, the participants in last week’s meeting examined mid- to long-term plans of the working group and proposals for working out new guidelines while discussing ways for cooperation with the working group for software medical devices within the IMDRF.

The working group’s mid- to long-term plans contained its future roadmap, including the explanation of key terms in 2022, regulatory designs, including those to be changed and managed, in 2023, manufacturing and quality control in 2025, things to consider before market launches in 2027, and the monitoring of actual use after marketing in 2027.