CDSCO Review Timelines & Fees
Review timelines (indicative)
CDSCO does not publish binding performance targets comparable to US MDUFA timelines. The following are indicative based on industry experience:
| Application type | Indicative timeline |
|---|---|
| Class A (Form MD-15) | 15–30 working days |
| Class B (Form MD-14) | 30–45 working days |
| Class C (Form MD-14) | 45–75 working days |
| Class D / new device (Form MD-14) | 90–180 working days |
| Renewal (all classes) | 30–45 working days |
| Amendment | 20–45 working days |
Query cycles (deficiency letters) can add significantly to overall timelines.
Fees
Fees are specified in the First Schedule to the Medical Devices Rules 2017 and may be updated by gazette notification. Fees are paid via the SUGAM payment gateway. Always confirm the current fee at CDSCO fee schedule or on the SUGAM portal before submitting.
Expedited pathways
Devices already approved by reference authorities (US FDA, EU, TGA, Health Canada, PMDA Japan) may be eligible for faster review under CDSCO's policy for already-approved devices. See New Device vs Already-Approved Device Routes.
Factors affecting timelines: CDSCO processing capacity, completeness of initial submission, complexity of the device, requirement for additional testing, and state of public health priorities. To estimate your likely timeline, consider: (1) whether your device is new to the Indian market; (2) the availability of clinical data from reference jurisdictions; (3) whether CDSCO may require local testing. Query cycles typically add 30–90 days per round.