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 manufacturers and importers are required to register in Integrated Medical Device Information System under Article 31-3 of Medical Device Act, Article 54-3 (4) of the Enforcement Decree of the same Act, and Appendix 7-2. This information (hereinafter referred to as ‘medical device information, etc.’) is necessary for the systemic and efficient recording and management of medical devices. The information that must be registered in the Integrated Medical Device Information System includes the following:
1) Information regarding medical device standard codes
2) Information about medical device products (including information on approval, certification, and reporting)
3) Information about medical device manufacturers and importers (including foreign manufacturers)
Integrated Medical Device Information must be registered after the medical device has been approved, certified, or reported, and before the device is shipped. If the registered medical device information is changed, it must be updated within 10 days from the date of the change. Additionally, if the head of the Integrated Medical Device Information Center determines that the medical device information is inaccurate or does not meet the requirements, the information must be corrected or modified and registered within 20 days from the date of the request.
The casebook provides practical examples to assist professionals in smoothly performing their tasks, covering various cases that may arise when using the system account for integrated information registration and management, medical device standard codes, barcord labeling, and the medical device supply report system, as well as the ‘Medical Device UDI Tracking and Management System.’
Please refer to the attached document below.
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