Available documents vary by model, manufacturer, equipment condition and destination-market requirements. Documents are normally provided in English and translated where required.
Declaration of conformity where applicable for the model.
Quality management documentation for the supply chain.
Specifications, test reports and IFU summary.
Local-language labels and IFU where required.
Inspection results, function-test logs, hour meter.
Civilian hospital / non-military use declaration.
The local importer leads registration. We provide supporting documents and coordination assistance where available; final requirements are determined by the relevant authority.
EAEU registration requirements vary by model, equipment condition and local regulations. The local importer submits the application; we provide available supporting documents.
EU CE (MDR/IVDR) requirements vary by product classification, manufacturer, equipment condition and applicable law. Market-entry timing must be assessed locally.
Importer License (MD-14 / MD-15) required. A local licensed importer handles the application.
HOKA provides supporting documents and coordination assistance. Final registration, import approval and customs clearance remain the responsibility of the local importer and relevant authorities.
Used and refurbished devices face extra scrutiny at import. Buyers and authorities want proof of origin, condition and conformity. A complete pack shortens clearance, reduces held shipments, and builds trust with hospitals and clinics.