Custom-Made Devices
A custom-made device is manufactured per written prescription from a qualified professional for a specific named patient.
Exempt from ํ๋ชฉํ๊ฐ / ํ๋ชฉ์ ๊ณ , but NOT exempt from:โ
- GMP requirements (manufacturer must be KGMP-certified)
- Labelling obligations
- Adverse event reporting
Requirementsโ
- Made specifically for a named patient per professional's written prescription
- Cannot be mass-produced
- Records kept for at least 10 years per device
Common examplesโ
Orthopaedic implants (patient-specific) ยท Dental prostheses ยท Custom-moulded hearing aids