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Local Clinical Testing in Russia

When local testing is required​

Local clinical testing in Russia is required when:

  • The device is innovative — no registered equivalent exists in the GRLS
  • The FGBU determines during Phase 1 review that existing clinical data is insufficient
  • Roszdravnadzor has specific concerns about data quality or applicability to the Russian patient population

For Class IIb and Class III devices, local clinical testing is frequently required. For Class I and IIa devices with substantial existing clinical documentation, it may be waived.

The National Ethics Committee​

Before any clinical investigation can begin in Russia, the investigation protocol must be approved by the National Ethics Committee under the Ministry of Health. This is a standalone approval step separate from the Roszdravnadzor registration process.

Key steps:

  1. Prepare clinical investigation protocol
  2. Submit to National Ethics Committee for review
  3. Obtain Ethics Committee approval
  4. Roszdravnadzor lifts the Phase 1 hold on the registration application
  5. Investigation conducted in approved Russian clinical centres
  6. Clinical data compiled and submitted to Roszdravnadzor (Phase 2)

Approved clinical centres​

Clinical investigations must be conducted in clinical facilities approved by the Ministry of Health for this purpose. The manufacturer or RUS REP identifies and contracts appropriate clinical centres.

Laboratory testing​

In addition to clinical investigations, laboratory and pre-clinical tests may also need to be conducted in Russian accredited laboratories. The FGBU National Institute of Quality may specify which tests must be performed locally.

Timeline impact​

Local clinical testing typically adds 6–18 months to the overall registration timeline, depending on:

  • Complexity of the investigation protocol
  • Time to obtain Ethics Committee approval
  • Patient enrolment speed at clinical centres
  • Data analysis and reporting time
Official source

Pre-clinical and clinical testing regulations (March 2022): minzdrav.gov.ru