Registration of medical devices according to the national procedure of the RF
The Medical Device Manufacturers Support Center provides comprehensive services for document preparation, testing organization, and dossier support to the Federal Service for Surveillance in Healthcare (Roszdravnadzor).
We prepare an application for state registration
of a medical device;
Within 3 months, we develop a complete set of technical and operational documentation necessary to begin testing;
We select accredited laboratories and offer optimal conditions in terms of testing timeframes and costs;
We organize and oversee the entire testing cycle: technical, toxicological, EMC, type approval testing of measuring instruments, and clinical testing. We assist with sample import, processing, and verification.
We communicate with laboratories, review protocols, and adjust documents if necessary;
We prepare a registration dossier and submit it to the Federal Service for Surveillance in Healthcare (Roszdravnadzor);
We promptly address
any concerns and prepare responses to inquiries from
the Federal Service for Surveillance in Healthcare (Roszdravnadzor) if they arise;
We provide you with information about the product’s inclusion in the Unified Register of Licenses (ERUL number).
All registration stages and documentation are coordinated with the Authorized Representative or manufacturer.
Based on all received data and documents, our specialists develop a complete registration dossier that meets the requirements of the Federal Service for Surveillance in Healthcare (Roszdravnadzor).
Starting in 2024, for risk class 2a (sterile), 2b, and 3 products, a manufacturing inspection conducted by an authorized government agency is mandatory in accordance with Russian Government Resolutions No. 135 and No. 136 of February 9, 2022.
Request a free consultation on the registration procedure and ask all your questions.
Reasons to choose our team:
We develop a detailed
registration plan in
collaboration with the manufacturer or authorized representative…More
Our staff includes experts with proven experience in the field of medical device registration;
We provide both full turnkey support and individual stages
of the registration process;
In case of registration refusal due
to our company’s fault, we will
refund the payment for services;
Individual solutions for complex
and non-standard projects.
We develop a detailed registration plan in collaboration with the manufacturer or authorized representative… More
Our staff includes experts with proven experience in the field of medical device registration;
We provide both full turnkey
support and individual stages
of the registration process;
In case of registration refusal due to our company’s fault, we will refund the payment for services;
Individual solutions for complex and non-standard projects.