01AR
EU Authorized Representative
EU representation for medical devices and IVDs, including authority communication, document holding and ongoing regulatory support.
EU & SINGAPORE REGULATORY GATEWAY
Your European Authorized Representative — built for Asian SMEs.
European compliance, Asian service speed. We help global manufacturers establish the representation, documentation and regulatory pathways needed to enter Europe with confidence.
● Bilingual regulatory support● Europe + Singapore presence● Practical preliminary triage
MARKET-ENTRY CAPABILITIES
One practical partner across the compliance pathway.
From legal representation to documentation readiness and product registration, Elpisia connects Asian manufacturers with the requirements of European markets.
02RP
Cosmetics · PPE · GPSR
Responsible Person and economic-operator pathways for cosmetics, personal protective equipment and general consumer products.
03TF
Technical file readiness
Pre-assessment, gap identification, labeling support and practical coordination before formal market entry.
04DB
EU registration & databases
Support for EUDAMED, CPNP, national EU databases and other relevant European Union registration pathways.
05SG
Singapore HSA pathway
Singapore-led regulatory consultancy for manufacturers pursuing European and ASEAN market access.
06BD
Market-entry support
Optional partner research, distributor introductions and structured business-development support for credible projects.
CE✓
ASIA
EUROPE
THE ELPISIA DIFFERENCE
Not a mailbox. A regulatory partner who understands both sides.
Many representatives provide an address and a contract. Elpisia combines an EU presence with Singapore-led coordination and real experience working with Asian manufacturing teams.
- ✓Clear English–Chinese communication
- ✓Pre-assessment before formal onboarding
- ✓Support for authority queries and ongoing compliance
- ✓A practical bridge between manufacturer, representative and market
FROM INQUIRY TO APPOINTMENT
A clear route from first question to market entry.
01Readiness assessment→
02Preliminary compliance screen→
03Scope and quotation→
04Agreement and onboarding→
05Ongoing representation
REGULATORY ANSWERS
Frequently asked questions
Do I need an EU Authorized Representative?+
A manufacturer established outside the EU generally needs an EU Authorized Representative before placing relevant regulated products on the EU market. The exact role depends on the product and legislation.
Can Elpisia review our documents first?+
Yes. We use a preliminary compliance screen to identify obvious gaps, confirm service fit and determine whether a deeper technical-file review is required.
Which products do you support?+
Our pathways cover medical devices, IVDs, cosmetics, PPE and general consumer products. Acceptance depends on product risk, documentation quality and the applicable regulation.
Does a successful quiz guarantee acceptance?+
No. The assessment is an initial guide, not legal advice, certification or acceptance. Elpisia retains the right to decline products or documentation that present unacceptable compliance risk.