JNM Global

Global Approval Partner

NIDS 3

Korea MFDS, Publishes a casebook of civil counseling for the registration and management of integrated medical device information

On November 22, 2024, the NIDS (National Institute of Medical Device Safety Information) published a casebook on consultation for the registration and management of integrated medical device information, based on the cases received through the helpdesk, email, National petition portal, and training.  Integrated medical device information refers to the information that medical device manufacturer..

Korea MFDS, publishes a casebook of civil counseling for reporting and management of medical device supply details

Based on major complaints received through education and civil service counseling, customized support, and helpdesk to minimize confusion and difficulties in reporting supply details by NIDS, the "Civil Service Counseling Casebook for Reporting and Management of Medical Devices" was published on November 22, 2024. Medical device supply details report shall be submitted to the Minister of Food an..

Korea MFDS, Announcement of revised medical device Adverse Event report guidelines

On May 27, 2024, the Ministry of Food and Drug Safety (MFDS) posted a revised version of the "Medical Device Adverse Event Report Guidelines" reflecting the revision of the standard code for medical device abnormalities and the frequently used standard code case. The medical device safety information management system is briefly as follows.1. If the medical device handler recognizes that death o..