— Services — Registration of Medical Devices in Russia and the EAEU — Registration within the EAEU

Professional transition to the unified regulations of the Eurasian Economic Union. We provide the most efficient registration process for products sales in five countries: Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan.

Assistance in selecting the reference country and countries of recognition to optimize the timeline and cost of the procedure

Compilation of a registration dossier in accordance with EAEU requirements

Arranging logistics and customs clearance for trial samples

Organizing clinical trials, liaising with expert and regulatory bodies in all selected countries, and monitoring the review process at every stage

Organizing and optimizing the cost and volume of translations for the required documentation

Preparing the manufacturer’s quality management system for an inspection to verify compliance with implementation and maintenance requirements, conducting a production inspection, and providing support throughout all stages of the assessment

Obtain your Registration Certificate in a timely manner.
We help you bring your product to market faster, ensuring a smooth and rapid launch.