South Korea – South Korea updates regulations on medical device codes and classification

The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, issued a draft revision to Regulations on Medical Device Codes and Classification. The MFDS also published guidelines on Pre-consultation for Medical Products, as well as updated lists of IVD clinical performance testing institutions and medical device non-clinical testing institutions. All links below are in Korean.

Draft revision to regulations on medical device codes and classification

The MFDS released the draft revision to the Regulations on Medical Device Codes and Classification (MFDS Notice No. 2022-20), dated March 14, 2022) for consultation until June 2, 2022. Notably, this revision proposes the establishment of new medical device items, specifically five new medical device subcategories, and changes to some medical device item names (including English names) and definitions. The changes were made in order to enhance the efficiency of medical device safety management by correcting classification problems that may be uncovered in the establishment of a new medical device item that is managed in another sub-classification or that requires a clear classification system for safety management, medical device authorization-examination or complaint processing…