Formally, entering the Ukrainian medical market is a multi-layered regulatory undertaking governed by mandatory national technical regulations, complex conformity assessment routes, mandatory technical file verification, quality management system compliance, and rigorous post-market surveillance integration.

In short, it is a demanding compliance lifecycle. However, we offer you 6 straightforward steps that simplify the entire procedure, provide absolute clarity on your involvement, give you a clear predictive timeline, and make market entry transparent and manageable.

At your service is our end-to-end support for medical device registration in Ukraine, which includes:

• Preparation and audit of the Technical File in accordance with Ukrainian requirements.

• Authorized Representative (AR Service) representation for foreign manufacturers.

• Support during audits by conformity assessment bodies and obtaining Conformity Certificate.

• Registration in the State Service of Ukraine on Medicines and Drugs Control database and placing class 1 / in vitro medical products on the market.

• Quality Management System support (ISO 13485) and consulting on post-market surveillance (Vigilance).

With our support, you will minimize regulatory risks, avoid customs delays, and gain legal access to Ukraine’s healthcare market quickly and stress-free.