RegMedGrupp delivers full-cycle consulting for medical device registration with Roszdravnadzor and across the EAEU. Dossier preparation, testing coordination, expert review support, and GMP inspections of manufacturing sites across six jurisdictions.
17 years of working with medical device manufacturers — from single-product startups to international corporations with diversified portfolios.
Since 2009, RegMedGrupp has supported medical device registration under Federal Law 323-FZ and EEC Council Decision No. 46. Over this time, we have issued more than 1,000 Registration Certificates, conducted over 200 GMP inspections of overseas manufacturing sites, and have not received a single regulatory rejection since 2019.
Our approach is documentation engineering. We do not simply fill out forms — we design dossiers to meet the expert review criteria of TsMIKEE and VNIIIMT. Focus areas: Software as a Medical Device (SaMD), active implants, IVD diagnostics, active medical equipment. Risk classes 2a, 2b, and 3 — where expert review demands methodology, not templates.
We work under a contractor agreement with a fixed quote. Milestones, timelines, acceptance points, and responsibility for re-review cycles are all defined in a single document. No subscriptions or recurring fees after the Registration Certificate is issued.
Our experts have hands-on experience at Roszdravnadzor, in Rosaccreditation-accredited testing laboratories, at international manufacturers, and at federal clinical centers. We know the dossier evaluation criteria from the inside — we verify the completed dossier before submission.
Figures are updated quarterly based on the Roszdravnadzor registry and internal project statistics.
Regulatory affairs is neither magic nor luck. It is a methodology: verifiable, repeatable, and documented.
Hands-on experience at Roszdravnadzor and TsMIKEE. We know the dossier evaluation criteria and rejection triggers — and we cross-check the completed dossier before submission. This is not a review service; it is a methodology.
MDR, 510(k), ISO 13485, IEC 60601, ISO 14971 — embedded into technical specifications and operational documentation. Conversion of European and FDA dossiers into the Roszdravnadzor format.
Support for FBU inspections at foreign sites across six jurisdictions. Authorized representation in Russia for foreign manufacturers — without setting up a local legal entity.
Clinical evaluation programs at accredited federal medical centers. Protocols compliant with GOST ISO 14155.
Fixed-price service contract. No subscriptions or recurring fees after the Registration Certificate is issued.
Repeat expert evaluation cycles caused by our fault are covered at our own expense. Stipulated in the service contract.
Experience at Roszdravnadzor, accredited laboratories, foreign manufacturers, and federal clinical centers.
15+ years in medical device registration. Prior experience at Roszdravnadzor and TsMIKEE. Leads Class 2b and Class 3 risk projects.
ISO 13485, IEC 60601, ISO 14971. Conversion of MDR and FDA dossiers to the Roszdravnadzor format. 12+ years in the industry.
Support for FBU inspections across six jurisdictions. 10+ years in laboratories accredited by Rosaccreditation.
Clinical evaluation programs at federal medical centers. Protocols compliant with GOST ISO 14155, 8+ years in research.
Individual team composition is disclosed under NDA within a specific project. Competence is evidenced by the track record of issued registration certificates.
We support FBU inspections at manufacturer sites in China, Germany, Italy, Israel and the USA, acting as authorised representative under Federal Law 323-FZ — no Russian legal entity required from the applicant.
Hub for all projects: regulator liaison, testing coordination, and dossier expertise support.
South China tech park: primary manufacturing zone for electronic and in vitro devices destined for Russia.
QMS audit support and adaptation of European MDR dossiers to Russian and EAEU requirements.
Italy is the centre of expertise for implants and cardiovascular devices, with ISO 13485 audits for Russian submissions.
Israeli startup clusters are the main source of SaMD and AI diagnostic systems being registered in Russia.
Boston biotech cluster: we convert FDA-cleared devices into Russian registration certificates via the 510(k)-equivalent route.
Operational geography map. Equirectangular projection.
Five growth milestones since founding — from the first registration to 1,000+ Registration Certificates.
First team, first client, first Registration Certificate.
first RCSupport under EEC Decision No. 46. Six member states of the Union.
5 countriesLaunch of authorized representative services for foreign manufacturers.
authorized representativeImplementation of internal pre-audit of dossiers against TsMIKEE criteria. Zero refusals since that year.
0 refusalsOne thousand registered devices. SaMD, IVD, active implants, medical equipment.
1,000+ Registration CertificatesWhat sets us apart from typical regulatory consulting — by the numbers, not by promises.
A technical description, IFU and country-of-origin certificates are sufficient. NDA available on request prior to material exchange.