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 streamlined documentation requirements. MFDS may accept a technical specification summary or abbreviated test data instead of full performance test reports, provided the device poses minimal risk and conforms to applicable standards.
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 (quality management), ISO 14644 (cleanroom environment controls if applicable), ISO 18385 (IVD quality systems), and IVD-specific international standards (ISO 18113 series for glucose monitoring, ISO 12882 for blood gas analysers, and others as applicable to device type). Test reports demonstrating conformance must be from MFDS-recognised testing laboratories. Refer to MFDS guidance documentation for device-specific standard recommendations.
Korean-language labelling requirements
All labelling must be in Korean and include: • Product name (in both Korean and English acceptable) • Intended use and indications • Safety warnings and precautions • Instructions for use • Manufacturer name and contact information • Storage conditions and shelf life
English can be retained for technical terms if no suitable Korean equivalent exists, provided a Korean translation is provided. Labelling must be clear, legible, and placed on the device or packaging.