Jun 16, 2022

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.

Guidelines on pre-consultation process for medical products

The MFDS has released the Pre-consultation Process for Medical Products (Guidelines-0982-02). These guidelines include in their scope devices intended for the treatment of serious or life-threatening diseases for which there is no existing treatment. Although the guidelines are intended to determine the roles, responsibilities and detailed processing procedures of those involved in this pre-consultation service, the guidelines can be used as a reference for applicants, especially with regard to the preliminary review as well as the application review and processing procedures.

MFDS Notice No. 2022-261, Designation status of IVD clinical performance testing institutions

The MFDS issued Notice No. 2022-261 to provide the list of institutions designated for clinical performance testing of in vitro diagnostic medical devices as of May 31, 2022.

MFDS Notice No. 2022-254, Designation status of non-clinical testing institutions for medical devices

The MFDS published Notice No. 2022-254 to specify designated local institutions for the non-clinical testing of medical devices, as of May 30, 2022. For details, the latest list of designated institutions along with their scope of services is provided as an attachment to the notice.

Emergo by UL will post updates to South Korean medical device regulations as they become available.

Learn more about complying with South Korean medical device regulations from Emergo by UL:

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  • Kathryn Burke's picture
    Kathryn Burke

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