Xavi&Rea Solutions


  • Home
  • Assessors of Technical Documentation
  • Our Tasks
  • Notified Body
  • Our Scope
    • Medical Devices
    • In Vitro Diagnostic Medical Devices
    • Food Supplements
    • Cosmetics (including Make-up)
    • Fragrances and Essential Oils
    • Candles
    • Detergents
    • Chemical Mixtures
  • EU Representative
  • Import & Export Agents

Import & Export Agents for Out-of-EU Countries


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4. Import & Export Agents for Out-of-EU Countries



Definition:
s Import & Export Agents, we facilitate the movement of regulated products between the EU and non-EU countries, ensuring compliance with EU import/export regulations and customs requirements. This includes handling documentation, certifications, and logistics for our product scope.





Scope and Relevance:

  • For Medical Devices and IVDs, we ensure compliance with MDR/IVDR requirements for CE-marked products during import/export, including verification of certificates and labeling.
  • For Cosmetics, we manage CPNP notifications and import documentation per Regulation (EC) No 1223/2009. For Food Supplements, we verify compliance with Directive 2002/46/EC and customs labeling rules.
  • For Aromas and Fragrances, Candles, Detergents, and Chemical Mixtures, we handle REACH (Regulation (EC) No 1907/2006) and CLP (Regulation (EC) No 1272/2008) requirements, including SDS and hazard labeling for customs clearance.
  • Our Role: We provide end-to-end support, including regulatory checks, customs documentation, and coordination with authorities, to streamline the import and export process for out-of-EU manufacturers and distributors.


Xavi&Rea Solutions



Company Registration Number: C 112273
SOHO St. Julians Punchbowl Centre, Elia Zammit Street
ST. JULIANS STJ 3154 MALTA