Notification Requirements and Documentation
Required documentation
| Document | Notes |
|---|---|
| Application form | Via eSubmission portal |
| Device description | Product name, intended use, structural characteristics |
| Performance test data | From MFDS-recognised testing laboratory (applicable standards) |
| Korean-language labelling draft | Label and IFU in Korean |
| KGMP / Foreign GMP certificate | Valid and scope-appropriate |
| Business licence copy | 제조업 허가 or 수입업 허가 |
Grade I reduced burden
Grade I devices have the lightest documentation burden. A technical specification summary may suffice instead of full test reports.
Standards compliance (Grade II)
Test reports demonstrating conformance to applicable KS or recognised IEC/ISO standards required. Common standards: IEC 60601-1, ISO 10993, applicable device-specific standards.
Related pages
IVD Grade A and B standards compliance
For IVDs, applicable standards may include ISO 13485, ISO 14644 (cleanroom), ISO 18385 (IVD quality systems), and IVD-specific international standards (ISO 18113 series, ISO 12882). Refer to MFDS guidance documentation for device-specific standard recommendations.