Single-Use Devices and Reprocessing
Single-use devicesâ
Must be clearly labelled as single-use in Korean. Designed and validated for single use only.
Reprocessing of SUDsâ
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.