IVD Blueprint

Regulatory & Compliance Checklist for IVD Startups in India

131
Checklist Items
6
Sections
3
Scenarios

Scenario Filtering

Kit-only, Kit+Device, or Kit+App — see only what applies to your product

Progress Tracking

Track every item with statuses, priorities, and real-time completion stats

Export & Import

Save progress as JSON and restore it anytime across sessions

Reference Tables

Risk classes, CDSCO forms, fees, performance thresholds — all inline

CDSCO · MDR 2017 · ICMR-CDSCO 2025 Protocols · Built by Neodocs

IVD Diagnostic Startup — Regulatory & Compliance Checklist

India (CDSCO / MDR 2017) · Post-prototype regulatory roadmap · 131 items across 10 sections

Select Your Product Scenario

Scenario 1: Standalone IVD Kit

Rapid test kits, ELISA kits, PCR reagent kits — no electronic hardware, no software

Simplest · 1 license · 12–18 months · ₹15–40 lakh

Scenario 2: IVD Kit + Device/Reader

Kit + electronic reader/analyzer (PCR machine, ELISA reader, lateral flow reader)

Moderate · 2 licenses · 15–24 months · ₹40–65 lakh

Scenario 3: IVD Kit + Smartphone App

Kit + mobile app that reads/interprets results (SaMD); may include simple reader

Most Complex · 2–3 licenses · 18–24 months · ₹40–80 lakh

0
Applicable Items
0
Done
0
In Progress
0
Not Started
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Critical Pending

Import Progress

Load a previously exported JSON file to restore your checklist progress.

📂
Click to browse or drag & drop a file
Accepts .json files exported from this tool
Exported on—
Scenario—
Items tracked—
Done—
In Progress—
Applies (Kit/All)
Device-specific
App/SaMD-specific
Conditional
Not applicable