MECRA | Registration of medical devices

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.

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

Submit an application

Additional services

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