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Custom-Made Devices

A custom-made device is manufactured per written prescription from a qualified professional for a specific named patient.

Exempt from 품목허가 / 품목신고, but NOT exempt from:​

  • GMP requirements (manufacturer must be KGMP-certified)
  • Labelling obligations
  • Adverse event reporting

Requirements​

  • Made specifically for a named patient per professional's written prescription
  • Cannot be mass-produced
  • Records kept for at least 5 years per device from date of manufacture, or longer if required by applicable standards or the device's expected lifespan

Common examples​

Orthopaedic implants (patient-specific) · Dental prostheses · Custom-moulded hearing aids

Definition of 'qualified professional'

For the purposes of custom-made device exemption, a qualified professional is: • A licensed physician, dentist, or other healthcare practitioner registered with relevant Korean health authorities • The professional must write the prescription in their official capacity for direct patient care • The prescription must be documented and retained as part of the device record for at least 5 years

The prescribing professional bears responsibility for confirming the prescription is appropriate for the specific named patient.