European Authorized Representative EC-REP
Your compliant path to global markets
Under EU MDR 2017/745 and IVDR 2017/746, non-EU manufacturers must appoint a European Authorized Representative. We cover the mandate, EUDAMED registration, label review, incident reporting and post-market surveillance — end to end.
Our Services
Authorized representation for medical devices, covering the EU, the United States and Brazil — all four services are now live.
European Authorized Representative (EC-REP)
Your mandatory EU representative under MDR/IVDR: representation agreement, EUDAMED registration & SRN, label review, incident reporting & FSCA coordination, Certificates of Free Sale.
PPWR Packaging Authorized Representative
Written mandate under the EU Packaging and Packaging Waste Regulation (EU) 2025/40, plus EPR registration support for packaging placed on the EU market.
US Agent
FDA-required US Agent for foreign establishments: establishment registration & device listing, FDA correspondence and inspection support.
Brazilian Registration Holder (BRH)
ANVISA-required Brazilian Registration Holder (BRH) services: registration, import compliance and post-market maintenance.
Why Choose ARZENCE
Regulatory compliance is a long-term commitment. We accompany manufacturers through every stage — transparent, professional and traceable.
EU Representation in Portugal & Estonia
Authorized representation through established EU entities in Portugal and Estonia — real places of business, ready for competent-authority review at any time.
Bilingual Coordination, Zero Time-Zone Friction
Direct communication with our Shenzhen-based team; regulatory files, meetings and correspondence handled in both Chinese and English.
Global Authorized Representative Network
Representation across the EU, US and Brazil under one roof — unified onboarding, unified maintenance.
Our Process
A clear, predictable process — from first consultation to ongoing compliance maintenance.
Needs Assessment
Confirm product classification, regulatory route and service scope; receive a proposal and quote.
Agreement
Sign a bilingual authorized-representative agreement defining both parties' obligations.
Document Review
Review the declaration of conformity, technical documentation and representative labelling.
Registration
Complete registration, obtain identifiers and update labels before market placement.
Ongoing Maintenance
Vigilance reporting, FSCA coordination, Certificates of Free Sale and annual compliance support.
Ready for global markets?
Tell us about your products and receive a proposal within 24 hours.