Medical Device Supply Reporting Requirements Exempted for Grade 1 and Grade 2 Devices in Korea

Korea: The Korean Ministry of Food and Drug Safety recently convened the 6th Active Administrative Committee to discuss the necessary improvements related to the medical device supply reporting system. The primary objective of these enhancements is to ensure the smooth progress and operation of the Medical Device Regulatory Innovation 2.0 project.

Starting from July 13, 2023, the medical device industry will witness the exemption of supply reporting for Grade 1 and Grade 2 medical devices. This exemption is limited to medical devices excluding reimbursement-covered therapeutic materials and used medical devices.

Rationale for the Changes

The medical device industry has continually requested improvements in the reporting system since the implementation of Grade 2 medical device supply reporting last year. In response, the Ministry of Food and Drug Safety actively engaged with relevant industry associations and academia to identify improvement measures, culminating in the Medical Device Regulatory Innovation 2.0 project.

To support the transition and enhance the reporting system, the Ministry of Food and Drug Safety plans to implement various measures. These include operation during the transition period until December 2024, on-site education and technical support by region, and improving the user-friendliness of the medical device integrated information system. Furthermore, administrative disposal criteria for non-reporting companies will be enhanced, with penalties eased to a warning for first violations.

Transition Period 

Grade 1 medical devices are granted a reporting exemption, with their first reporting due in August 2023, to be submitted by the end of September. This means that only “reimbursement-covered therapeutic materials” requiring financial management for health insurance purposes and “used medical devices” requiring enhanced distribution management will continue to be reported. All other Grade 1 and Grade 2 medical devices will be exempt from reporting.

For Grade 2 medical devices, they can report supplies for June 2023 until July 31, 2023, taking advantage of the improvements made in the system.

An exemption has also been introduced concerning the obligation to reissue medical device standard codes when there are changes to the product or model names of permitted, certified, or reported medical devices. This improvement aims to streamline product identification, aiding in the rapid and accurate identification and tracking of devices with potential adverse effects.

Reduction in Annual Burden

The industry foresees a reduction in the annual burden of reissuing around 2,600 medical device standard codes and related cost savings for new standard codes’ packaging and printing. The Korea Medical Device Industry Association welcomes these supply reporting system improvements, expressing their commitment to actively promote the stable establishment of the improved system and cooperate closely with the Ministry of Food and Drug Safety by providing education and support to sales companies.

The Korea Medical Device Industry Association also anticipates a significant reduction in economic burdens for manufacturers and importers, thanks to the improved issuance criteria for medical device standard codes.

To facilitate the stable establishment of the reporting system, a transition period will be implemented until December 31, 2024. During this time, the focus will be on improving the reporting system, expanding on-site education, and promoting compliance.