Accelerated medical device registration
Lawful placement of products on the Russian market within the shortest possible timeframe under RF Government Resolution No. 552.
Temporary Registration Certificate in as little as 8–22 working days for a rapid market launch.
Testing in our own laboratories, without intermediaries or unnecessary markups.
A lawful option to complete the clinical data package while the product is already on the market.
Full legal and regulatory support through issuance of a permanent Registration Certificate.
How long does the state procedure take?
The timelines are strictly regulated by Russian Federation legislation. The simplified route allows all state stages to be completed several times faster than under the standard procedure.
- From 5 working daysExpress registration for non-sterile Class 1 medical devices
- From 15 working daysstatutory period allocated to the expert institution for dossier assessment
- From 7 working daysStatutory period for Roszdravnadzor to make the final decision and issue the registration certificate
Which medical devices qualify for simplified registration?
The Interdepartmental Commission decides whether products are included in the special list based on the risk of shortage in the Russian market or the manufacturer’s readiness to offer a price below the market average.
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Resuscitation equipment, including mechanical ventilators and oxygenators - Personal protective equipment, including isolation suits, gowns, respirators and gloves
- In vitro diagnostic test systems and reagents
- Complex equipment and consumables in risk classes 2a, 2b and 3 approved by the commission
The list currently contains more than 2,200 medical-device type codes and is continuously updated
How accelerated registration works
Initial Dossier Preparation — 1 to 3 Working Days
- Development and revision of Technical Specifications (TU) and operating documentation by Resultat-Audit experts.
- Preparation of the power of attorney for the manufacturer’s authorized representative for foreign manufacturing sites.
Submission to Roszdravnadzor — 1 Working Day
Official submission of the completed document package and medical-device registration application.
State Expert Review and Decision — 5 to 22 Working Days
- Route A — non-sterile Class 1 devices: accelerated assessment of quality, effectiveness and safety — 5 working days.
- Route B — Classes 2a, 2b and 3: expert review by the authorized organization (15 working days) plus the final Roszdravnadzor decision (7 working days), for a total of 22 working days.
Issuance of a temporary registration certificate
An entry is made in the State Register. The applicant obtains the lawful right to import, circulate and sell the product in the Russian Federation.
Comprehensive Testing — up to 150 Working Days
Organization and conduct of mandatory technical, toxicological and clinical testing using the Group’s own accredited laboratories.
Permanent registration certificate
Submission of the final test reports to Roszdravnadzor in order to replace the temporary status with a permanent, indefinite registration certificate.
Documents for Accelerated Registration
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Minimum package for initial submission — temporary registration certificate- State registration application in the prescribed form.
- Copy of the document confirming the authority of the manufacturer’s authorized representative — for foreign applicants.
- Manufacturer technical documentation for the medical device.
- Operating documentation, including instructions for use and user manual.
- High-resolution digital photographs showing the general appearance of the device and its components.
- Documents to be submitted within 150 working days
- Technical test reports for the medical device.
- Toxicological study report for devices that come into contact with the human body.
- Clinical trial assessment report, based on clinical studies and/or data analysis as applicable.
Still have questions?
Submit a request and we will call you back within one hour, review your case and propose a solution.
Companies
Services for obtaining medical device Registration Certificates and preparing medical device documentation. We work in accordance with EAEU rules and Roszdravnadzor requirements.
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