Solution — Medical Devices & Biotech

Your International Distributors
Need to Be Screened. Every Time.

Medical devices and biotech equipment are dual-use by nature. EAR and OFAC obligations apply to every international sale. TradeLasso automates restricted party screening so your compliance team is always audit-ready.

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OFAC SDN & Treasury Lists BIS Entity & Denied Persons BIS Unverified List State AECA Debarred List Daily Database Updates

The Compliance Risk Is Built Into Your Product Category

Medical devices and biotech equipment aren't dangerous products. But their capabilities — imaging, sensing, culturing, analyzing — give them export control classifications that create real compliance obligations on every international transaction.

Medical and biotech equipment is frequently dual-use

Imaging systems, centrifuges, fermenters, mass spectrometers, and diagnostic equipment all have civilian and potential military or WMD applications. BIS classifies many under ECCNs that require license review for certain destinations and end users.

Research partnerships create deemed export obligations

Sharing controlled technology with a foreign national — even inside the U.S. — is a deemed export requiring compliance review. International collaborations with universities and research institutes amplify this risk significantly.

Distributors in emerging markets are high-risk by default

Medical device demand is growing fastest in Southeast Asia, the Middle East, and Latin America. Regional distributors and local agents in these markets must be screened at onboarding and regularly thereafter.

Reputational risk compounds financial penalties

For medical and biotech companies, an export violation isn't just a financial penalty — it can jeopardize FDA relationships, clinical trial approvals, government contracts, and institutional partnerships that took years to build.

A violation in medtech carries consequences beyond the fine

For companies in regulated industries, an export violation can affect FDA relationships, government contract eligibility, and institutional research partnerships. The compliance program you build today protects more than your trade privileges.

What TradeLasso Does for Your Compliance Team

From new distributor onboarding to research partnership due diligence — TradeLasso handles the screening so your team can focus on the analysis.

Screen new international distributors in seconds

Before signing a distribution agreement in any new market, search the distributor name and key principals in TradeLasso. All 13 U.S. government lists, simultaneously, in under 5 seconds. Your legal team gets a clean screening record before contracts are finalized.

Catch name variations in complex institutional names

Research institutions, hospital networks, and biotech companies often operate under long formal names, acronyms, and translated versions. TradeLasso's fuzzy matching catches partial matches, transliterations, and known aliases — and scores every result so your team can prioritize review.

Batch-screen your entire distributor network

Upload your existing distributor or customer list as a CSV. TradeLasso processes every name in one job — hit, clean, or error — with match scores and matched entity names. Export the full results for your compliance program file.

Audit-ready documentation for every transaction

Every screening generates a timestamped PDF report — entity name, database version, date, all results. Attach it to the distribution agreement, purchase order, or export file. When a BIS or FDA audit comes, the records are already organized.

Re-screen at renewal and major order milestones

Save distributors and research partners to Saved Profiles. Re-screen them before annual contract renewals, territory expansions, or large equipment orders. The sanctions list changes frequently — your screening cadence should match your commercial activity.

Cover every party in the transaction

In medtech and biotech, the invoice counterparty is often not the only party that matters — end users, procurement agents, hospital purchasing groups, and research institution PI offices may all require screening. TradeLasso makes it fast to screen all of them.

Before TradeLasso vs. After

What changes for your compliance team from day one.

Task	Manual Process	With TradeLasso
New distributor onboarding screen	30–45 min across multiple government portals	Under 60 seconds in TradeLasso
Annual distributor re-screen (100 names)	3–5 days of manual work	1 batch job, results in minutes
Research partner due diligence	Ad hoc, inconsistently documented	Structured search + PDF report per partner
Audit documentation	Reconstructed from emails and memory	Automatic timestamped history + reports
Database currency	Stale government site downloads	Daily sync with official U.S. CSL

The Regulatory Framework for Medtech & Biotech Exports

TradeLasso covers the lists published by every U.S. agency relevant to medical device and biotech exports.

EAR

Export Administration Regulations · Commerce Dept. — BIS

Controls dual-use goods including a wide range of medical and scientific equipment. Many devices have ECCNs that trigger license requirements or enhanced due diligence for certain country groups and end users.

OFAC

Office of Foreign Assets Control · Treasury Dept.

Economic sanctions apply to all exports, including medical devices. While OFAC maintains humanitarian exceptions, these are narrow — sales to sanctioned parties generally remain prohibited.

BIS Lists

Entity, Denied Persons & Unverified Lists · Commerce Dept. — BIS

The Entity List, Denied Persons List, and Unverified List identify parties subject to enhanced license requirements. Research institutions and government-affiliated labs appear on these lists with increasing frequency.

ITAR

International Traffic in Arms Regulations · State Dept. — DDTC

Applies to medical or biotech equipment with defense applications — including some imaging, sensing, and diagnostic technologies on the U.S. Munitions List. Defense-adjacent products require ITAR screening in addition to EAR.

TradeLasso screens against all 13 lists in the U.S. Consolidated Screening List simultaneously. See the full list breakdown →

How It Fits Your Sales & Compliance Process

TradeLasso fits into your existing workflow — no integration, no new systems required.

New distributor, partner, or customer identified

Business development or sales team identifies a new international distributor, hospital network, or research institution.

Compliance runs the screening

Search the entity name, key officers, and procurement contacts. Review any matches with scores. Document the analysis.

Generate the compliance report

One click creates a timestamped PDF. Attach it to the distribution agreement, RFP response, or purchase order file.

Proceed or escalate

Clean result? Proceed to contract. Hit? Review carefully, document your determination, and escalate to legal if needed.

Build a Compliance Program That Grows With Your International Business

The more markets you enter, the more parties you need to screen. TradeLasso scales with your business — from 10 distributors to 1,000 — without adding headcount or complexity to your compliance team.

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Your International Distributors Need to Be Screened. Every Time.