Regulatory Readiness — EquiTrak Pro
67/100
Overall Readiness Score: 67/100
CONDITIONAL GO — 3 critical blockers must be resolved before launch
🇮🇳
India
CDSCO
In Progress
2 blockers | 4 ready items65%
🇦🇪
UAE
MOHAP
Pending
3 blockers | 3 ready items55%
🇹🇭
Thailand
Thai FDA
Not Started
5 blockers | 2 ready items20%
🇸🇬
Singapore
HSA
Almost Done
1 blockers | 5 ready items80%
Blockers
- 🔴 CDSCO India: Hindi IFU translation missing (blocking India submission)
- 🔴 CDSCO India: Sterilization validation document missing
- 🔴 UAE: Arabic IFU 60% complete — submission blocked
- 🔴 CE Mark: Expiry Mar 2026 — renewal critical path (affects all markets)
- 🔴 Free Sale Certificate: Expired Dec 2025, needed for India + UAE
Ready Items
- ✅ CE Certificate (core) — accepted in Singapore, UAE, Thailand
- ✅ ISO 13485 Certificate — valid until Dec 2027
- ✅ Clinical Evaluation Report v5.0
- ✅ AIIMS Delhi pilot study — CDSCO-relevant
- ✅ FDA 510(k) clearance
- ✅ Technical File complete
AI Action Plan
- Hindi IFU — engage translation vendor this week (2 week turnaround) → unblocks India
- Arabic IFU — accelerate completion from 60% to 100% (1 week) → unblocks UAE
- Sterilization Validation — request from manufacturer (4 weeks)
- CE Mark renewal — confirm renewal application with TÜV Rheinland; if delayed, affects all markets
- FSC renewal — contact manufacturer urgently