Single-Use Devices and Reprocessing

Single-use devices

Single-use devices ​ Must be clearly labelled as single-use (일회용) in Korean on both packaging and device. Manufacturers must provide validation data demonstrating that the device is designed and tested for single use only, with documented performance degradation or safety concerns if reused. IFU must explicitly state: "This device is intended for single use only. Reuse may result in device failure, contamination, or patient harm."

Reprocessing of SUDs

Reprocessing is a regulated activity in Korea. Reprocessors must use MFDS-approved protocols and are treated as manufacturers for regulatory purposes. MFDS guidance specifies which SUD categories may be reprocessed and which are prohibited.

Reprocessor requirements ​ MFDS prohibits reprocessing of certain high-risk SUDs (cardiac catheters, implantables, critical access devices). Reprocessors must: ​ • Register with MFDS as a medical device manufacturer • Obtain approval for each SUD reprocessing protocol • Validate cleaning, sterilisation, and functionality for each reprocessing cycle • Maintain traceability of reprocessed units • Implement post-market surveillance to monitor device performance ​ Reprocessed devices must bear new labelling and UDI-K codes.

Reprocessor approval timeline

Reprocessors must obtain MFDS approval before marketing reprocessed devices. The approval process requires: (1) submission of detailed reprocessing protocols including cleaning procedures, sterilisation methods, and quality control testing; (2) bench-top and performance validation studies demonstrating the device functions as intended after reprocessing; (3) traceability documentation linking original device manufacturer to the reprocessed product; and (4) liability insurance or manufacturer consent. Approval timelines typically range from 3–6 months for standard SUDs to 6–12 months for complex devices. Reprocessors are legally responsible for device safety and must maintain post-market surveillance records.