Complete Market Entry for Medical Devices
From device classification & regulatory approval to distributor onboarding, KOL activation & commercial sales — across 26 global markets.
Most Firms Stop at Approval
Getting a registration certificate is step one. Without distribution, clinical validation, and sales infrastructure — your device sits on a shelf.
The Regulatory Maze
Device classification varies by market. Class II in India may be Class III under MDR in Europe. Wrong classification means rejection, delay, and wasted cost.
We handle classification in all 26 markets — mapping the correct pathway per authority before a single document is submitted.
Nine Services. One Team. Complete Access.
Available individually or as a full end-to-end market entry programme.
Market Intelligence
Regulatory landscape, competitive mapping, pricing intelligence, hospital procurement analysis.
Product Registration
Class A–D registration with CDSCO, TGA, MHRA, SFDA, CE — full dossier preparation.
Legal Representation
In-country Authorised Representative and Statutory Agent for MDR, IVDR, CDSCO, TGA.
Imports & Shipments
Import licence management, customs clearance, demo unit handling, port-to-hospital logistics.
Warehousing & Inventory
In-market storage, real-time inventory, cold-chain handling, capital equipment delivery.
Distributor Identification
Pre-qualified distributors by device category from our network across 26 markets.
End to End Marketing
Brand localisation, KOL engagement, clinical event support, digital marketing.
Sales Support
Hospital sales deployment, demo coordination, tender strategy, procurement engagement.
Six Phases to Market Success
Click any phase to explore. Regulatory and commercial workstreams run in parallel.
Market Intelligence
What We Do
Device category sizing, regulatory pathway mapping, competitive analysis, pricing intelligence, distributor landscape assessment, and go/no-go recommendation.
Before committing a single document, we map the full landscape — so every decision that follows is data-driven.
Built for These Device Manufacturers
International Device Manufacturer
Foreign brand with CE Mark or FDA 510(k), entering India, Southeast Asia, or the Middle East for the first time.
We provide the complete market entry infrastructure — regulatory, distribution, clinical, and commercial — from day one.
Registered But Not Growing
Registered in 1–2 markets but sales are flat. Distributor underperforming. No KOL programme, no tender presence.
We audit, rebuild the distributor, activate KOLs, and launch a structured sales programme.
Going to Market Direct
Manufacturing under OEM contracts, now bringing own-label products directly to market across multiple geographies.
We manage the full journey under a single contract — your external market access team.
Why Device Manufacturers Choose Taevas
Specialist Device Team
Dedicated regulatory, clinical, and commercial specialists. Not generalists.
Pre-Qualified Distributors
Networks mapped, vetted, and qualified by device category across 26 markets.
Active KOL Relationships
Surgeons, cardiologists, radiologists, and clinicians in key markets.
Regulatory + Commercial
Same team handles registration and commercial launch. No handoff.
258+ Brands Launched
Class I–III, IVD, and SaMD platforms across every major market.
Post-Market Support
PMCF, vigilance, renewals, re-registration, and market withdrawal.
What Success Looks Like
German Orthopaedic Implant Manufacturer
Class C orthopaedic implant system with CE Mark
CDSCO registration in 8 months. Distributor onboarded Month 9. First hospital tender Month 11. First commercial order Month 12.
South Korean Imaging Company
Capital imaging equipment
Parallel registrations across 14 months. 6 distributors activated. Regional sales deployed by Month 15.
US SaMD Platform
AI-powered diagnostic imaging analysis (SaMD)
CDSCO SaMD classification completed. 12-hospital partnership in India. Pilot revenue Month 11.