Prajnex.com

India RegulatoryTimeline Estimator

Get a realistic CDSCO registration timeline estimate based on your device classification, existing approvals, and clinical evidence package. Understand what drives your timeline — and how to compress it.

1. Device Classification
Your CDSCO device class under Medical Devices Rules 2017
Class A
Low risk
Class B
Low-medium risk
Class C
High risk
Class D
Very high risk
Unknown
Need to determine
2. Existing Regulatory Approvals
Select all current approvals your device holds
CE Mark (EU MDR 2017/745) — current certification
CE Mark (EU MDD — legacy, pre-MDR)
FDA PMA (Premarket Approval)
FDA 510(k) clearance
Other major market approval (TGA Australia, Health Canada, PMDA Japan)
No approvals yet — device in development
3. Clinical Evidence
What clinical evidence exists for your device?
Randomised controlled trial published in peer-reviewed journal
Multi-centre prospective study (200+ patients)
Single-centre study or retrospective data (50+ patients)
Indian patient data included in any study
Pre-clinical only — no human clinical data yet
4. Accelerating Factors
These factors can meaningfully compress your timeline
Experienced India regulatory consultant already engaged
Indian KOL champions identified and willing to support CDSCO
Technical dossier already prepared (CE or FDA submission format)
Full India registration budget approved and available