Product Database โ Submitting and Updating Records
Initial submissionโ
After obtaining ํ๋ชฉํ๊ฐ or ํ๋ชฉ์ ๊ณ , register the device in KIMS via the MFDS eSubmission portal before placing it on the market.
Required data elements:
- Product name and description
- ํ๋ชฉํ๊ฐ / ํ๋ชฉ์ ๊ณ number and date
- Device grade and classification code
- Manufacturer details
- UDI-K Device Identifier (DI) โ once assigned
- Key device attributes (sterility, implantable status, reuse, etc.)
When to update recordsโ
KIMS records must be updated when:
- Product name or description changes
- New models or variants added
- Manufacturing site changes (following ๋ณ๊ฒฝํ๊ฐ/์ ๊ณ )
- Product is discontinued (record must be closed/archived)
- ํ๋ชฉํ๊ฐ is modified