All Medical Devices and In Vitro Diagnostics intended for the Russian market must be registered with the Ministry of Health of the Russian Federation (Minzdrav) through Roszdravnadzor, the body responsible for issuing the necessary authorisations for marketing, verification of regulatory compliance and post-marketing surveillance.

The application for registration, submitted by the Authorised Local Representative, must include complete documentation under Ministerial Decree No. 13/2022.

The registration dossier must contain administrative documents, a technical file, ISO 9001 and 13485 certificates, declarations of conformity, detailed information on the medical device and product samples. In addition, data on the Authorised Local Representative, the Manufacturer and, if different, the Production Facility must also be provided.

If a medical device consists of separate modules produced by different companies, each module must be registered individually.

All devices must undergo local testing, including biocompatibility and toxicology tests; for Class IIa, IIb and III devices, clinical investigations are mandatory once the first stage of technical approval has been completed. These tests and clinical investigations must be conducted in authorised centres in Russia, even if the device is already on the market in other countries. 

Decree No. 135/2022 provides mandatory production site inspections for all domestic and foreign manufacturers of Class IIa (sterile), IIb and III Medical Devices.

During the evaluation process, the application may be rejected or you may be asked to supplement it with additional information, research or tests. The status of the request can be monitored via the official Roszdravnadzor website.

Applicant

The foreign manufacturer intending to market Medical Devices in Russia must appoint an Authorised Local Representative, who is responsible for product compliance from registration to post-market surveillance.

Timeframes and Costs

The approval time for an application varies and can take between 6 and 16 months, and can extend to 2-3 years if the documentation requires numerous refinements following feedback from Roszdravnadzor.
The costs for initial registration depend on the risk class, starting at around 72,000 roubles (RUB).

Validity

The registration certificate is valid indefinitely unless regulatory changes or changes to device specifications require a new evaluation.

Documentation Language and Labelling

Russian.

Useful Information

Russian regulation follows the principles of harmonisation with the requirements set by the Eurasian Economic Union (EAC), in which Russia plays a central role. Russia is also part of the International Medical Device Regulatory System (IMDRF). The rules currently in force are particularly stringent, but changes are planned toward simplified compliance.