IVD Classification — Grades A · B · C · D
IVD devices follow a separate 4-grade system (A, B, C, D) under the IVD Act.
| Grade | Risk | Examples | Pathway |
|---|---|---|---|
| A | Lowest | General lab instruments, specimen collection containers | 품목신고 |
| B | Low–medium | Blood glucose meters, general chemistry analysers | 품목신고 |
| C | Medium–high | Blood typing reagents, HbA1c kits, HIV confirmatory tests | 품목허가 |
| D | Highest | HIV screening tests, blood donor screening, NAT tests | 품목허가 |
Classification factors for IVDs
- Risk of an erroneous result — what is the clinical consequence of a false positive or false negative?
- Use in donor screening — always high risk (Grade C or D)
- Intended use population — high-risk/vulnerable groups elevate grade
- Public health surveillance implications
Companion diagnostics
Classified at Grade C or D — see Companion diagnostics.
Relevant legislation
- IVD Act, Articles 2 and 6
- MFDS Notification — IVD Device Classification and Grade Assignment