As of October 11, 2024, the Ministry of Food and Drug Safety has registered the revised version of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials). The revised contents of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials) are briefly as follows.
1. Reasons for revision: Revision of the procedure for reviewing the adequacy of domestic abnormal cases
2. Revision Contents
가. (Emergency information, etc.) Direct action by the Ministry of Food and Drug Safety
① Distribution status survey [Ministry of Food and Drug Safety]: Investigation of distribution status including production and export, import, and repair performance / Cooperation with the Medical Device Management Division (if necessary)
② Request for surveillance and collection inspection [Ministry of Food and Drug Safety → Regional Office]: Request for surveillance and collection inspection of distributed medical devices from the Ministry of Food and Drug Safety (Regional Office) / Cooperation with regional office (if necessary)
③ Review of surveillance results and collection inspection results [Local office, testing and inspection agency → Ministry of Food and Drug Safety]: Review of surveillance results (Local office) and collection inspection results (test and inspection agency) for the relevant medical device handler
④ Request for inspection of medical devices with frequent occurrence of identical product defects [Ministry of Food and Drug Safety → Regional Office, etc.]: Request for inspection, etc. to confirm appropriateness of quality control, etc. for medical devices with multiple reports of identical product defects
※ Inspection target: Among adverse events that occurred domestically due to medical devices, and among adverse events with a risk level of severe or higher, the target was selected from medical devices in which the same product defect occurred multiple times.
나. (Information of Interest) Action through medical device companies
① Request for submission of data for review of the appropriateness of adverse event reports [Information source → Medical device manufacturer (importer)]: Only in cases where measures are required based on the analysis results of safety information such as adverse events by evaluating the degree of harm, possibility of occurrence, sensitivity, potential factors, expected adverse events, causal relationships, etc. of the reported adverse events
- Request for submission of supporting data for review of appropriateness, such as adverse event reports and cause analysis of adverse events
※ In case of insufficient submission data from manufacturing (import) companies, additional data is requested
② Request for notification of notice or submission of recall plan [Ministry of Food and Drug Safety → Medical device manufacturer (importer)]
* In case it is known that a medical device causes or is at risk of causing harm to the human body due to poor quality, etc.
For more information, please refer to the attached file below.
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