Your Authorized Representative in 50+ Markets.
One Partner. One Platform.
NexorX is the independent, conflict-free in-country representative for MedTech companies holding your licences neutrally, monitoring every regulator with AI, and compiling submission ready dossiers so you launch faster everywhere.
Your market access shouldn't live in your distributor's name
In most of the world, your registration or import licence is issued to your in-country representative. Appoint the wrong one, and your entire market is hostage to a single commercial relationship.
✗ Distributor as your representative
The licence sits in their name. Change distributors and you may re-register from scratch losing months of revenue and market presence.
✗ A different consultant in every country
Fragmented files, duplicated fees, no single view of your global compliance status and nobody accountable end to end.
✓ NexorX independent by design
We hold your licences neutrally with zero commercial interest in your sales channel. Appoint, add or replace distributors freely. Leave anytime with a complete, audit-ready file guaranteed.
Independent Licence Holding
Registrations held by a neutral representative, never a sales partner. Your market access stays yours in all 50+ markets.
Clean Transfer Guarantee
Onboard from your current AR without downtime. And if you ever leave us, you get a complete, audit-ready handover. No hostages.
One Dashboard, Every Registration
View and track every registration, renewal, vigilance obligation and regulator query worldwide live, in one place.
AI that drafts. Experts who sign off.
Our regulatory AI works alongside in-country specialists compressing months of documentation into weeks, with every output reviewed by qualified professionals before it reaches a regulator.
⚡ Regulatory Intelligence, Live
AI monitors rule changes, guidance updates and fee revisions across 50+ regulators — and tells you what actually impacts your portfolio.
📝 IEC 62304 & Risk Files, Drafted
Software lifecycle documentation (IEC 62304), ISO 14971 risk management files and usability evidence drafted by AI from your inputs, reviewed by our engineers.
📦 Submission Data, Compiled
eSTAR, EU MDR technical files, CDSCO dossiers and more — AI assembles, cross-checks and gap-flags your submission data before human QC.
nexorx › scan –markets 50 –portfolio “Class B SaMD”
✓ 3 regulatory changes affect your device this week
→ FDA eSTAR update (Jun 2026): 2 new cybersecurity fields
→ CDSCO: SaMD guidance revision — labelling impact
→ EU MDR: harmonized standard refresh for 62304
nexorx › draft –doc “IEC 62304 SDS” –from repo
✓ Draft generated · 47 sections · routed to human review
nexorx › compile –submission MD-14 –market IN
✓ Dossier 94% complete · 2 gaps flagged for your team
One partner. 50+ regulators.
In-country representation, licence holding, regulatory liaison and post-market vigilance everywhere you sell.
From first launch to fifty markets
Launch right the first time
Enter your first export markets without building local entities or regulatory headcount.
- Market prioritization & pathway strategy
- AI-drafted 62304 & risk documentation
- Predictable, startup friendly engagement
Scale without the sprawl
Expand to 10-20 markets in parallel while your dossier does the work once.
- Parallel multi-market submissions
- Reliance pathways from FDA / CE approvals
- Consolidated renewals & vigilance calendar
Consolidate the chaos
Replace dozens of fragmented local reps with one accountable global partner.
- Portfolio wide AR/LR transfer program
- Single dashboard across all registrations
- Audit-ready files, everywhere, always
Four steps to global market access
Map
Free assessment of your device, target markets, classifications and the fastest reliance pathways from your existing approvals.
Appoint
Appoint NexorX as your independent representative in each chosen market. PoAs, regulator accounts and licence structures handled.
Submit
AI compiles and gap checks each dossier; in-country experts localize, submit and manage every regulator query to approval.
Maintain
Vigilance, renewals, change notifications and 24/7 regulatory monitoring one dashboard shows your global compliance status.
Frequently Asked Questions
What is an Authorized Representative for medical devices?
An Authorized Representative (in-country representative, local representative or authorized agent) is a legally registered local entity appointed by a foreign manufacturer to act on its behalf before a national regulator for example EC REP under EU MDR, UK Responsible Person under UKCA, or Indian Authorized Agent under CDSCO. Most regulators won’t accept registrations from foreign manufacturers without one. NexorX provides this in 50+ markets with one accountable partner.
Why choose an independent representative instead of my distributor?
In many markets the registration or import licence is issued in your representative’s name. If your distributor holds it, your market access is tied to that commercial relationship switching distributors can force a full re-registration and months of lost sales. NexorX holds licences neutrally, so you appoint, add or replace distributors freely, and leave anytime with a complete, audit ready file.
Which markets does NexorX cover?
50+ markets across the Americas, Europe, the UK, Asia, the Middle East, Oceania and Africa including US FDA (US Agent), EU MDR/IVDR (EC REP), UKCA (UKRP), India CDSCO (IAA), China NMPA, Japan PMDA, South Korea MFDS, Brazil ANVISA, Mexico COFEPRIS, Saudi SFDA, UAE MOHAP and Australia TGA.
How does NexorX use AI in regulatory work?
Our AI engine monitors regulatory changes across 50+ markets in real time, drafts IEC 62304 software lifecycle documentation and ISO 14971 risk management files, and compiles submission data for dossiers like FDA eSTAR and EU MDR technical files. Every output is reviewed and signed off by qualified regulatory professionals before it goes anywhere near a regulator.
Can we transfer our existing representatives to NexorX?
Yes, We run representative transfers market by market PoA changes, regulator notifications and licence transfers while keeping your products on the market. Our clean transfer guarantee works both ways: join without downtime, and if you ever leave, take a complete audit-ready file with you.
Is NexorX only for startups?
No, NexorX serves MedTech companies at every stage startups entering their first export markets, mid-size manufacturers scaling to 10-20 countries, and large enterprises consolidating dozens of local representatives into one accountable partner.
Ready to make 50+ markets feel like one?
Book a free assessment. We’ll map your fastest pathways, flag the risks in your current representative setup, and show you the platform live.