Taevas
PolandMarket Entry & Growth in Poland
Poland is Central Europe's largest life-sciences market, offering a skilled talent base, EU-aligned regulation under URPL, and a rapidly modernising healthcare system. Taevas delivers end-to-end market entry support so your brand moves from registration t
CE Mark
URPL Registration
GMP Certificate
$10B+
Healthcare Market Size
Top 10
EU Pharma Market Rank
38M+
Population
16
Voivodeships Covered
Industries We Support
Four Industries. One Poland Team.
Select an industry to see regulatory pathways, services, and how Taevas supports your Poland market entry.
Medical Devices & Equipment
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
Poland's medical device sector is governed by EU MDR 2017/745 and EU IVDR 2017/746, administered locally by URPL. With a healthcare market valued above $10 billion and significant public hospital procurement through the National Health Fund (NFZ), Poland presents a compelling opportunity for device manufacturers. Taevas manages CE marking strategy, URPL notifications, authorised representative services, and distributor onboarding to accelerate your market entry.
Regulatory Pathways
Mandatory
CE Marking & EU MDR Compliance
All medical devices placed on the Polish market must carry CE marking under EU MDR 2017/745. Taevas coordinates technical documentation, conformity assessment with a Notified Body, and Declaration of Conformity preparation.
Mandatory
URPL Device Notification
Devices must be registered in the Polish URPL database prior to market placement. Taevas handles the full URPL notification submission, including classification review and supporting documentation.
Mandatory
Import & Customs Clearance
Medical devices entering Poland require compliant customs documentation aligned with EU import rules. Taevas coordinates freight, customs brokerage, and import licensing to ensure uninterrupted supply.
Ongoing
Post-Market Surveillance
EU MDR mandates ongoing post-market surveillance, vigilance reporting, and periodic safety update reports. Taevas maintains your PMS system and manages URPL incident reporting on your behalf.
Our Services for Medical Devices in India
Why Taevas Poland
Why Global Brands Choose Taevas for Poland
Taevas combines deep URPL regulatory expertise with established distributor and KOL networks across Poland's 16 voivodeships, giving life-sciences brands a proven path from registration to commercial success.
Regulatory
URPL Regulatory Expertise
Our Poland team has hands-on experience navigating URPL marketing authorisation procedures, EU MDR device notifications, and GIS product registrations across all four life-sciences verticals. We reduce submission errors and accelerate approval timelines.
EU Access
EU Market Gateway
Poland's EU membership means a successful market entry here opens the door to broader European expansion. Taevas leverages Poland as a strategic launchpad, with MRP and DCP regulatory routes that extend your approvals across EU member states.
Speed
Accelerated Time to Market
Our pre-built relationships with URPL contacts, customs brokers, and GDP-certified logistics partners in Poland mean your products move from dossier submission to shelf faster than if you were building these connections from scratch.
Distribution
Established Distributor Network
Taevas maintains active relationships with vetted pharmaceutical, medical device, and health-retail distributors across Poland's key commercial centres including Warsaw, Krakow, Wroclaw, and Gdansk, giving your brand immediate market reach.
KOL Access
KOL and Clinical Networks
We have mapped and engaged Poland's leading clinical opinion leaders across oncology, cardiology, endocrinology, and primary care, enabling credible medical education programmes and evidence-based brand positioning from day one.
Track Record
Proven Market Entry Track Record
Taevas has supported multiple international life-sciences brands in successfully entering the Polish market, delivering compliant registrations, commercial distribution agreements, and measurable revenue growth within defined timelines.
Get Started
Ready to Enter the Poland Market?
Book a free consultation with our Poland life-sciences team and receive a tailored market entry assessment covering regulatory timelines, distributor options, and a clear path to first revenue.
Free Poland assessment
URPL and GIS regulatory specialists
Nationwide distributor coverage across 16 voivodeships
End-to-end to revenue