We offer professional, reliable and overwhelming assistance in state registration of medical devices in Ukraine. We have a great knowledge of all aspects of state registration, we can offer the best regulatory solution for your products, we can save you from all problems and risks and guarantee obtaining the marketing authorization in shortest terms.

1. General information on regulatory system of medical devices in Ukraine

State requirements to legalization of medical devices, taxation system and other aspects of import, manufacture and marketing of medical devices, stages and general information on marketing authorization procedure.

2. New registration (first marketing authorization) of medical device

All necessary information on procedure of marketing authorization of medical devices, flow-chart of the procedure, list of necessary documents for filling the Application, prices and terms.  

3. List of documents (structure of registration dossier) required for marketing authorization of medical device.  

List of documents with requirements to legislation that should be submitted for marketing authorization (state registration) of medical device in Ukraine.

4. Renewal of registration and implementing variations to registration documents

Description of the process of renewal of registration and re-registration due to variations (changes) to approved documents, list of necessary documents, prices and terms.

5. Local legal acts and international guidelines in the field of marketing authorization of medical devices

List of valid legal acts that regulate procedure of state marketing authorization of medical devices in Ukraine. Directives of European Union and other international legal acts.

6. State registry of medical devices of Ukraine

State registry of medical devices contains information regarding devices that obtained marketing authorization, it’s manufacturers, applicants, custom commodity codes and other information related to marketing authorization.