A European manufacturer entering Central Asia, the Caucasus or Eastern Europe faces two sets of rules: the EU regulation its device was built under, and the registration regime of the market it is going to. This page describes how we handle both — and what we do not claim.
We supply only CE-marked devices that comply with the Medical Device Regulation or, for in-vitro diagnostics, the IVDR. Conformity is the manufacturer's responsibility; checking that the documentation is complete and current before a device ships is ours.
Import, storage and transport follow GDP guidelines — including cold chain for temperature-sensitive goods, with freezers down to −86 °C, and handling of fragile instruments such as analysers and autoclaves.
KombiMED's quality management is aligned with ISO 9001. For clean-room projects, the ISO 14644 classifications apply in addition.
Exports are checked against the German Foreign Trade Act (AWG) and the EU dual-use regulation, and cleared under the Union Customs Code.
A CE mark does not open the Eurasian Economic Union. Each target market has its own registration, and without it a device cannot be sold, installed or serviced there. This is the part manufacturers most often underestimate — and the part we take over.
Preparation of the registration dossier from the manufacturer's technical documentation, adapted to the requirements of the target market.
Submission to the authority and follow-up through the procedure — EAEU registration and country-specific certification, including metrological approval where required.
Keeping registrations valid as devices, software versions and regulations change — CE marking, ISO 13485 evidence, EAEU and EU MDR documentation handled as one lifecycle.
The markets we register for: Central Asia, Eastern Europe, the Caucasus, the Baltics, the Middle East and North Africa — 18 markets in total.
Once a device is in use, safety does not stop at the border. We monitor and pass on device-related incidents, manage field safety corrective actions together with the manufacturer, and cooperate with the competent authorities — in Germany, the BfArM.
To report a safety concern about a device we supplied, write to sales@kombi-med.com.
Compliance also means respecting the agreements a manufacturer already has. We work within existing distribution structures and exclusivity arrangements — not around them.