CDSCO current fee schedule, reviewed for 2026, in USD.
21 fee lines100% exact amountscurrency USDFX rates 2026-09-07reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Import licence - Class A manufacturing site | USD 1,000 | $1,000 | Per site | Verified |
| Import licence - Class A device | USD 50 | $50.00 | Per distinct device | Verified |
| Import licence - Class B manufacturing site | USD 2,000 | $2,000 | Per site | Verified |
| Import licence - Class B device | USD 1,000 | $1,000 | Per distinct device | Verified |
| Import licence - Class C/D manufacturing site | USD 3,000 | $3,000 | Per site | Verified |
| Import licence - Class C/D device | USD 1,500 | $1,500 | Per distinct device | Verified |
| Import licence - IVD Class A/B manufacturing site | USD 1,000 | $1,000 | Per site | Verified |
| Import licence - IVD Class A/B device | USD 10 | $10.00 | Per distinct device | Verified |
| Import licence - IVD Class C/D manufacturing site | USD 3,000 | $3,000 | Per site | Verified |
| Import licence - IVD Class C/D device | USD 500 | $500 | Per distinct device | Verified |
| Manufacture licence - Class A/B site | INR 5,000 | $52.88 | Per site; retention fee is the same | Verified |
| Manufacture licence - Class A/B device | INR 500 | $5.29 | Per distinct device | Verified |
| Manufacture licence - Class C/D site | INR 50,000 | $529 | Per site; retention fee is the same | Verified |
| Manufacture licence - Class C/D device | INR 1,000 | $10.58 | Per distinct device | Verified |
| Inspection of an overseas manufacturing site | USD 6,000 | $6,000 | Per inspection | Verified |
| Permission to conduct a pilot clinical investigation | INR 100,000 | $1,058 | Per permission | Verified |
| Permission to conduct a pivotal clinical investigation | INR 100,000 | $1,058 | Per permission | Verified |
| Permission for clinical performance evaluation | INR 25,000 | $264 | Per permission | Verified |
| Permission to investigate a new device with no predicate | INR 50,000 | $529 | Per permission | Verified |
| Permission for a new in-vitro diagnostic device | INR 25,000 | $264 | Per permission | Verified |
| Export certificate for a medical device | INR 1,000 | $10.58 | Per certificate | Verified |
Government fees only — service and testing costs are separate- Import-licence fees are denominated in USD under the Medical Devices Rules; domestic-manufacture, investigation, and certificate fees are in INR.
- Site and per-device fees are cumulative; IVD import fees are lower than the non-IVD schedule (e.g. USD 10 per Class A/B IVD device).
- Test/evaluation/demonstration imports cost USD 100 per device; government-hospital patient-treatment imports cost INR 500 per device.
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Exact amounts verified against the CDSCO fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:india:import-licence-class-a-site