Clinical Evaluation Requirements

Overview

All medical devices submitted for registration in Russia must be supported by clinical evidence demonstrating safety and performance. The extent of clinical evidence required depends on device class and whether the device is innovative (no registered equivalent in Russia).

Clinical data requirements by class

Class	Clinical evidence required
Class I	Existing clinical literature review may be sufficient; local testing often waived if adequate data available
Class IIa	Clinical evaluation report required; local testing may be waived if good-quality existing data is available
Class IIb	Clinical evaluation report required; local clinical testing typically required
Class III	Full clinical evaluation required; local clinical testing generally mandatory

What constitutes clinical evidence

Clinical evidence may consist of:

• Published clinical literature (peer-reviewed studies, systematic reviews from indexed databases) (must meet international standards, preferably ISO 14155 or equivalent) technological and clinical to a registered device in the GRLS scientifically from post-market surveillance of already-registered devices Clinical data must be presented in a structured Clinical Evaluation Report prepared by a qualified technical expert.
• Clinical investigation data from studies conducted abroad
• Equivalent device clinical data (where equivalence can be justified)
• Post-market clinical follow-up data

For innovative devices (those with no registered equivalent in Russia), local clinical testing is mandatory, not discretionary.

Innovative devices

For devices with no registered equivalent in Russia, a local clinical investigation must be conducted. This means:

1. The manufacturer must design a clinical investigation protocol
2. National Ethics Committee approval must be obtained before starting the investigation
3. The investigation must be conducted in approved Russian clinical centres
4. Results are submitted to Roszdravnadzor as part of Phase 2 of registration

This requirement adds considerable time to the registration process — plan for several additional months at minimum.

Pre-clinical testing

Pre-clinical test reports (safety and biocompatibility testing, electrical safety, EMC) must be included in the dossier. All testing should align with applicable GOST R standards. Where testing is conducted outside Russia, reports from internationally accredited laboratories are generally accepted, but the FGBU may require supplementary local testing.

Official source

Government Decree No. 1684 (2025): government.ru