GLGlossary
UDI (Unique Device Identification).
A unique identification code assigned to each medical device so that it can be traced through distribution.
It consists of a device identifier (UDI-DI) and production information such as lot number and expiry date (UDI-PI), which must be shown on the container or packaging and also registered in Korea's integrated medical device information system. Because it is linked to supply reporting after sale, the obligation does not end with approval — it carries through into distribution. How the code is applied and what has to be registered can differ by product type, such as software or kit configurations.
Related work & timing
This comes up once approval is granted and you are preparing to sell, and is handled together with label design and registration in the integrated information system.
Basis
- Medical Device Act (Korea) — Article 20 (Particulars to be stated on containers, etc.)
- Regulation on Labeling and Management of Medical Device Unique Device Identification (MFDS notification)
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.
Other terms
← Back to glossary- Regulatory approval
- Classification (device class)
- Technical documentation
- KGMP (manufacturing and quality management standard)
- Test report
- Clinical evaluation
- Import and manufacturing business
- Post-market management
- Certification body / review body
- Labeling and advertising
- ISO 13485
- Manufacturer and manufacturing site
- Identical, equivalent, and improved devices
- CB test report
- Validation
- Risk management