Medical device registration
Comprehensive services for the registration of medical devices in accordance with the regulatory requirements of the Russian Federation and the EAEU
The companies LLC «Result-Audit» and LLC «Medalis» provide full-cycle services for the registration of medical devices in Russia and the EAEU. They develop technical and operational documentation in strict compliance with regulatory acts, Government Decrees of the Russian Federation, orders of the Ministry of Health of the Russian Federation, Roszdravnadzor requirements, and EEC decisions.
The complete registration cycle includes the preparation of documentation, coordination with the testing laboratories of the ElectronTest Group of Companies, monitoring of tests, and preparation of medical device samples. Clinical and clinical laboratory trials for In Vitro products are also organized, together with the preparation of the registration dossier and support of the registration process with Roszdravnadzor.
The ElectronTest Group also includes ElectronTest LLP, which specializes in comprehensive medical device registration in Kazakhstan and other EAEU countries.
Our approach
Preparation of technical and operational documentation
Testing in the in-house laboratories of the ElectronTest Group
Organization of clinical trials
Preparation and submission of the registration dossier to Roszdravnadzor
Obtaining the registration certificate
Key Figures
788
Total Registration Certificates Received
Period:
2013 — 2025
2013 — 2025
Implants
49
Neuromodulators, hyaluronic acid implants, dental implants and others
56
Other
Products not included in other groups
Cardiology
30
Cardiac stents, guidewires and others
Urology
46
Urological catheters, stents, baskets, guidewires, sling systems, lithotripters and others
Stomatology
129
Dental products, instruments
General Hospital Products
59
Hospital furniture, rehabilitation equipment, lighting, irradiators and others
146
In Vitro
Diagnostic Products
Diagnostic Products
Analyzers, reagents, calibrators, control materials
Surgery
58
Surgical instruments
68
X-ray equipment, IVF equipment, CT/MRI, defibrillators and others
Large and Complex Equipment
Changes and Modifications (BIRD and BIRU)
147
Implementation of changes to dossiers (with and without expertise) and registration certificates
Key Figures
Implants
49
Urology
46
68
General Hospital Products
788
Total Registration Certificates Received
period 2013 — 2025
59
146
Changes and Modifications (BIRD and BIRU)
147
Stomatology
129
Surgery
58
56
Other
Cardiology
30
In Vitro Diagnostic Products
Large and Complex Equipment
Analyzers, reagents, calibrators, control materials
Products not included in other groups
Dental products, instruments
Urological catheters, stents, baskets, guidewires, sling systems, lithotripters and others
Cardiac stents, guidewires and others
Hospital furniture, rehabilitation equipment, lighting, irradiators and others
Neuromodulators, hyaluronic acid implants, dental implants and others
X-ray equipment, IVF equipment, CT/MRI, defibrillators and others
Surgical instruments
Implementation of changes to dossiers (with and without expertise) and registration certificates
