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

JNM Global 제이엔엠글로벌 2024. 11. 28. 10:54

 

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 and Drug Safety by the end of the following month based on the month in which medical device manufacturers, importers, sellers, and renters supply medical devices to medical institutions, medical device sellers, and renters.

 

The medical devices subject to the improved medical device supply details in July 24 include human implantable medical devices (limited to class 3 and class 4 medical devices) and treatment materials eligible for nursing care benefits (when supplied to medical institutions). From the report data in June 24, reporting is required for medical devices that were improved in July 24.

 

In the case of medical device manufacturers and importers, if the number of the manufacturing business license and the in vitro diagnostic business license are different, membership must be registered separately. If a medical device manufacturer or importer supplies other companies' medical devices, membership must be registered as a medical device seller to report the supply details.

 

Please refer to the attached document below.

붙임. 의료기기 공급내역 보고 및 관리를 위한 민원상담 사례집.pdf
10.60MB


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