Describe your device and within 24 hours we will assign the risk class under Government Decree No. 1684, define the regulatory pathway, and estimate timelines and cost. We accept inquiries by phone, e-mail, Telegram, and via the form below.
GMP inspections, documentation audits, and localization of the registration dossier for the Russian Federation and the EAEU across six jurisdictions.
Head office: liaison with the regulator, test coordination, expert review support.
The main manufacturing region for electronics and IVD devices destined for the Russian market.
We adapt European MDR dossiers to Russian and EAEU requirements.
We also work with small manufacturers.
We register medical software and AI diagnostic systems by Israeli developers in Russia.
We prepare devices already cleared for the US market for registration in Russia.
RegMedGroup presence map
Full company details for contracts and invoices. NDA available upon request.
Risk class, registration pathway, list of required tests, and time-to-RC — all in a single email.