India's Specialist Interventional Device Advisory

Your strategic pathway
into India's medical
device market.

Prajnex helps interventional and implantable medical device companies navigate India's regulatory landscape, enter the market with clinical confidence, and build the relationships that drive adoption.

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6
Device verticals
we serve
15+
Years interventional
device expertise
₹50B
India market size
by 2030
3
Live device programs
led to market
🗺️
India's regulatory landscape is uniquely complex
CDSCO's Medical Devices Rules 2017 require Class C and D devices to navigate a multi-stage approval process — with local clinical investigation requirements that can add 12–18 months if not managed correctly from day one.
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Most global medtech companies enter India with generic market entry consultants who lack the clinical and technical depth to have meaningful conversations with Indian interventionalists and neurosurgeons.
KOL relationships are everything — and most companies don't have them
⏱️
Time lost is market share lost
Companies that start India market entry without a structured regulatory and clinical strategy spend 30–40% longer than necessary in the registration process — and arrive in market after competitors who moved faster.
What We Do

Six services.
One clear pathway.

From first regulatory enquiry to successful India launch — and from investment evaluation to acquisition due diligence — Prajnex provides the clinical intelligence, regulatory expertise, and commercial strategy that device companies and investors need at every stage.

Entry Point
India Regulatory Pathway Assessment
Before committing budget to India, understand exactly what CDSCO requires for your specific device — classification, documentation, clinical investigation obligations, timeline, and cost. A 15-page definitive assessment delivered in 3 weeks.
Typically delivered in 2–4 weeks →
Core Service
CDSCO Registration Support
End-to-end MD-15 application management for Class C and D devices. Technical dossier review, CDSCO liaison, query response management, and amendment handling. We navigate the process so you focus on your device.
Engagement scoped to your device and timeline →
Premium
India Market Entry Strategy
KOL mapping and engagement, competitive landscape, pricing and reimbursement strategy, distributor identification, hospital market access planning — the complete commercial blueprint for India launch.
Delivered as a complete commercial blueprint →
Advanced
Clinical Study Design & Management
Protocol design, ethics committee submissions, investigator site identification, patient recruitment modelling, and data management oversight for India-based device clinical investigations.
Scoped to study design and indication →
Due Diligence
Medtech Investment & Acquisition Due Diligence
For private equity firms, family offices, and strategic acquirers evaluating interventional or implantable device assets with an India dimension. We provide rigorous clinical, regulatory, and commercial due diligence that financial advisors cannot — assessing CDSCO regulatory risk, clinical evidence credibility, KOL relationship quality, market sizing accuracy, and commercial viability against India's pricing and reimbursement reality. A single missed regulatory risk can swing valuation by 30–40%. We find it before the deal closes.
Engagement scoped to transaction complexity →
Get in touch →
Medical Education
Clinical Adoption & Medical Education Programmes
Regulatory approval is step one. Getting Indian interventionalists to adopt your device is a completely different challenge. Prajnex designs and delivers the clinical adoption programmes that bridge the gap — therapy awareness webinars, KOL engagement and training, CME content development, physician proctoring protocols, and investigator-initiated study support. We turn regulatory approval into market penetration.
Programme scoped to device category and launch timeline →
Get in touch →
Our Specialties

Six device verticals.
One firm. Full depth.

Prajnex brings genuine clinical and regulatory depth across six interventional and implantable device specialties — built from hands-on program leadership spanning device R&D, regulatory strategy, clinical development, and commercial market access.

Neurovascular
Flow diverters, stent retrievers, intracranial stents, coils, aneurysm devices
Structural Heart
TAVR, MitraClip, LAA closure, septal occluders, transcatheter valves
Peripheral Vascular
Peripheral stents, balloons, DVT thrombectomy, PAD intervention systems
Spine & Neuromodulation
Spinal cord stimulation, intrathecal delivery, vertebral augmentation
Interventional Oncology
Embolization systems, ablation devices, biopsy and access tools
Orthopedic Implants
Joint reconstruction, trauma fixation systems, bone substitutes
Free Resources

Start with our free tools.

Four interactive tools to help you understand your India regulatory position — no form, no sales call required. Use them, share them, and reach out when you're ready to go deeper.

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India Market Entry Readiness Assessment
12 questions across 5 dimensions. Get a scored readiness report with priority recommendations for your India market entry strategy.
Take Assessment →
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CDSCO Device Classification Checker
3-step classification checker. Understand your device class under Medical Devices Rules 2017 and the documentation requirements it triggers.
Check Classification →
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Regulatory Timeline Estimator
Input your device class, existing approvals, and clinical evidence. Get a realistic best-case, probable, and conservative CDSCO registration timeline.
Estimate Timeline →
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Clinical Study Feasibility Screener
10 questions across 5 dimensions. Determine whether a local clinical investigation is required — and assess India's feasibility as a study location.
Screen Feasibility →
Who We Help

Three client segments.
One shared challenge.

Navigating India's medical device regulatory and commercial landscape without the right local partner is the challenge. We are that partner.

01
Primary Segment
Foreign Device Companies
Mid-size European and US interventional device companies entering India. Regulatory-heavy, KOL-dependent, need a partner who understands their device technically and India's market commercially.
CE MDR FDA Cleared Market Entry CDSCO Registration
02
Growing Segment
Indian Medtech Startups
BIRAC-funded and incubator-backed companies with innovative interventional device ideas that need regulatory strategy, clinical study design, and commercial planning to reach market.
BIRAC Funded Class C/D Clinical Strategy Market Access
03
Specialist Segment
Investors & Acquirers
PE funds, family offices, and strategic acquirers evaluating Indian or foreign interventional device assets who need rigorous clinical, regulatory, and commercial due diligence.
Due Diligence Clinical Assessment Regulatory Risk Market Sizing
Why Prajnex

The depth no
generalist has.

01
Bench-level device expertise
Our team brings genuine bench-to-market device development experience across interventional specialties. We can have the technical conversation your KOLs need before they will endorse anything.
02
CDSCO regulatory depth
Deep knowledge of Medical Devices Rules 2017, Class C/D registration pathways, clinical investigation design, ISO 14971 and ISO 13485 compliance, and CDSCO query management — built from leading three live device programs through Indian regulatory processes.
03
Warm KOL relationships
Years of KOL engagement and clinical publication management across interventional specialties. We don't cold-call Indian physicians — we have existing conversations.
04
Commercial and clinical in one firm
Most regulatory consultancies are pure compliance shops. Most commercial advisors don't understand the device. Prajnex bridges both — from CDSCO submission to distributor selection to hospital market access strategy.
What Sets Us Apart
Technical Depth
Hands-on device development experience — from bench to regulatory submission. We speak the language of your engineers and your physicians equally.
Regulatory Precision
Deep CDSCO expertise built from leading multiple Class C and D device programs through Indian regulatory processes — not theoretical knowledge.
Clinical Network
Established relationships with interventional specialists and KOLs across India's leading tertiary care centres — built over years of clinical program management.
Our Founding Team
Senior leadership with 15+ years of hands-on medical device program experience spanning R&D, Regulatory Affairs, Clinical Development, Commercial Strategy, and Quality Assurance — across multiple live interventional device programs.
Get Started

Ready to map your
India pathway?

A 30-minute strategy call. No sales pitch. No boilerplate advice. Just a direct conversation about your device, your timeline, and what India entry realistically looks like for your organisation.

We respond to all enquiries within one business day. Your details are never shared with third parties.
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