A European manufacturer entering Central Asia, the Caucasus or Eastern Europe faces two sets of rules: the EU regulation its device was built under (MDR 2017/745 or IVDR 2017/746) and the registration regime of each target market. KombiMED GmbH checks the EU side before shipment and takes over registration in 18 markets, from dossier to lifecycle. Its quality management is aligned with ISO 9001; it does not claim a certification it does not hold.
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. KombiMED takes over this part in 3 steps (dossier, submission and lifecycle), including EAEU registration, country-specific certification and metrological approval where required, for 18 markets in 6 regions.
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. KombiMED monitors and passes on device-related incidents under MDR 2017/745 and IVDR 2017/746, manages field safety corrective actions together with the manufacturer, and cooperates with the competent authorities (in Germany, the BfArM) for devices supplied to any of the 18 markets it serves.
To report a safety concern about a device we supplied, write to sales@kombi-med.com.
Yes. Compliance also means respecting the agreements a manufacturer already has. KombiMED GmbH works within existing distribution structures and exclusivity arrangements, not around them. It adds sales in the 18 markets it serves without replacing a partner the manufacturer already has. Since 2017 it has completed 125+ projects in 18+ project countries on this basis.
Market entry, registration and distribution in 18 markets.
Which markets, which registrations, which timeline.