IVD Classification
What is an IVD?
An in vitro diagnostic (IVD) medical device is any device — including reagents, kits, instruments, and software — intended to examine specimens derived from the human body, such as blood, urine, tissue, or swabs, to provide information for diagnosis, monitoring, or prognosis.
IVDs notified under Schedule II of MDR 2017 are subject to CDSCO licensing.
IVD risk classification
IVDs follow a distinct classification track based on two axes:
- Risk to the individual patient (personal health consequence of incorrect result);
- Risk to public health (impact of widespread incorrect results, e.g., for communicable disease screening).
| Class | Risk profile | Examples |
|---|---|---|
| Class A | Low individual / low public health | General chemistry reagents, blood cell counters |
| Class B | Moderate individual / low public health | Pregnancy tests, fertility hormones, PSA kits |
| Class C | High individual / moderate public health | Blood glucose meters, blood gas analysers, HbA1c |
| Class D | High individual / high public health | HIV, Hepatitis B/C, blood group typing, COVID-19 |
Regulatory pathway for IVDs
Class A IVDs: Form MD-15 (self-declaration / registration, no CDSCO pre-market approval required; notification to CDSCO may be required post-market). Class B IVDs: Form MD-14 (import license application via CDSCO / SUGAM, with CDSCO approval). Class C, D IVDs: Form MD-14 (import license application via CDSCO / SUGAM, with mandatory CDSCO technical review and approval).
Analytical and clinical performance data from CDSCO-notified or internationally accredited laboratories is required for Class C and D IVDs. Clinical data requirements may be waived if substantial equivalence to a legally marketed device can be demonstrated.
Laboratory Accreditation for IVD Performance Testing
For Class C and D IVDs, analytical and clinical performance data must be generated by:
- CDSCO-notified laboratories (list available on CDSCO website)
- Laboratories accredited by internationally recognized bodies (NABL, CAP, ISO 15189)
- Manufacturer's own facilities, provided they meet CDSCO-prescribed quality standards and have demonstrated technical competency in IVD testing
Manufacturers should verify laboratory status before commissioning tests to avoid delays in product submission and registration.