Accessories and Parts

Accessories are classified independently from the parent device based on the accessory's own risk profile and intended use with the parent device. An accessory may carry a different grade to its parent.

Each accessory requires its own 품목허가 or 품목신고 — it cannot be included in the parent device's authorisation unless MFDS explicitly accepts it.

Spare parts used to repair approved devices are generally not subject to pre-market requirements, but must be sourced from MFDS-recognised repair services.