Medical Equipment
Competent Registration Agency

Registration of medical devices in the Russian Federation and EAU
(medical equipment, consumable materials, in vitro)
Submit an application

About us

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
  • Medical devices for ostomates (ostomy paste, powder, ostomy rings, ostomy skin protective wipes)
  • 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.

Services rendered by the Company

Our company renders the following services for obtaining a Registration Certificate:
 
Customer consultations
on the composition and preparation of documents for the medical device registration
 
Preliminary analysis
of the Customer's documentation, preparation and approval of the application for the medical device registration by the Customer
 
Risk class and medical device type determination according to the Nomenclature Classification of Medical Devices
 
Preparation of documentation
for obtaining an authorization to import medical devices for registration purposes
 
Bringing the Customer's documents (technical and operational documentation, etc.) to consistency with the current legal requirements of the Russian Federation and EAU
 
Translation and notarization of documents
 
Interaction with laboratories, organization and support of toxicological studies, technical and clinical trials of medical devices, EMC tests, testing and approval of measuring instruments type
 
Compilation of the registration dossier and its submission to the Federal Service for Surveillance in Healthcare (Roszdravnadzor)
 
Support of the application at all stages of registration (local procedure, EAC procedure)
 
Customer support at all stagesof interaction with regulatory authorities under the EAC procedure
 
Obtaining the issued Registration Certificate from the regulatory authority and transferring it to the Customer

Additional services

SPECIAL OFFER
  • SPECIAL OFFER: We provide the services of an authorized representative of the manufacturer in the Russian Federation. You can register your medical device with us first. And then look for a distributor to sell. A ready-made registration certificate. Saving time.
  • Introducing amendments in the Registration Certificate, registration dossier (AMA, ARD)
  • Obtaining the Declaration of Conformity
  • Obtaining a Mandatory GOST R Certificate of Conformity
  • Obtaining a Voluntary GOST R Certificate of Conformity
  • Obtaining a License for the Production and Maintenance of Medical Devices
  • Manufacturing inspection support

Our advantages

Customer-oriented approach
Our solutions are individual for each Customer, regardless of the complexity of the tasks
Our Team
The company's experts have more than 10 years of experience in this field
Support
Substantial consultations on the process at any stage of registration
Price and time of services rendering
Our commercial offer is specific and considers the Customer's details

Our customers

 

Submit an application