Medical Equipment
Competent Registration Agency

Medical Equipment Competent Registration Agency (MEСRA) – this abbreviation provided the basis for our company name. We provide assistance and constantly increase our competence in registering medical devices. Experts of MEСRA, LLC, have more than 10 years of experience in this sector. Registration of medical devices is a time-consuming and extensive process that results in issuing a Registration Certificate, which gives the right to circulate medical devices within the territory of the Russian Federation. We offer our customers comprehensive support at all registration stages: analysis of the existing documentation, elaboration of the technical and operational documentation under the current legal requirements, organization of toxicological studies, technical tests, clinical trials, collection and submission of a dossier to the Federal Service for Surveillance in Healthcare (Roszdravnadzor). Our experts are always ready to provide up-to-date information on the case status and prepare the information needed in case of notification. Based on the work performed, they will give the Registration Certificate to the Customer.

We always keep up with the times, offering solutions to any challenges of the registration process.
We provide customer support at various registration stages, realizing that registering medical devices according to the rules of the EAEU and the National Procedure is costly in the current reality. The cost of registering medical devices we offer is optimal and affordable for each stage of the process and turnkey services. In case of a complex project (more than one RC), we guarantee our customers special price offers. Our goal is the result.

Registration Certificates for medical devices of the following directions have been received:

• Cardiology and Cardiac Surgery:electrocardiographs, guiding catheters, balloon catheters, angiographic catheters, introducers, radial artery compression devices, coronary cannulas, arteriotomy cannulas, femoral arterial and venous cannulas, implantable cardioverter defibrillator (ICD), electrodes, programmers, artificial heart valves.
• Artificial Blood Circulation: blood highway systems, ECMO highways, pumps, oxygenators, reservoirs, CPB.
• Orthopedics and Traumatology: articular implants, knee/hip/shoulder endoprostheses, revision prostheses, suture anchors, tools, reamers, screws.
• Artificial Lung Ventilation (ALV), Patient Monitors
• Breast Implants
• Ultrasonography (US)
• In Vitro Fertilisation (IVF): incubators and environments
• Neurostimulation: programmers and programming heads
• Bandages: negative pressure wound therapy (NPWT) devices and bandages
• Dentistry: dental implants, scanners, intraoral scanners
• Neonatology and Pediatrics: incubators and systems
• Diabetes: glucose meters, test strips, control solutions
• Other: gastrointestinal probes, gastroenterological stents, breathalyzers, surgical staplers and staples, observation beds

We have successfully implemented various projects for Sorin Group Rus, Terumo Russia, Johnson & Johnson, GE, Altimedica, Draeger, KaWe, Buinak Aggregate Factory, Ascensia Diabetes Care, etc. We are always glad to have mutually beneficial cooperation. Become our customer too.