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) – it is this abbreviation that provided the basis for our company name. We constantly increase our competence in the field of registration of medical devices. Experts of MEСRA, LLC, have more than 10 years of experience in this sector. The registration of medical devices is a time-consuming and extensive process which results in issue of a Registration Certificate, which gives the right to circulate medical devices within the territory of the Russian Federation. We offer comprehensive support at all stages of the registration: analysis of the existing documentation, elaboration of the technical and operational documentation in accordance with the current legal requirements, organization of toxicological studies, technical tests, clinical trials, collection and submission of a dossier. Our experts are always ready to provide up-to-date information on the case status, prepare the required information in case of notification. And on the basis of the work performed the Registration Certificate will be given to the Customer. We are always pleased to be involved in mutually beneficial cooperation. Аmong our clients: Johnson and Johnson, GE healthcare, Livanova, Sorin, KaWe, Drager, Ascensia etc.

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