Russia medical device registration timeline

Source-linked clocks

Federal Service for Surveillance in Healthcare (RZN) review clocks and end-to-end planning ranges, using the 4-class (1, 2a, 2b, 3) — EAEU classification classification system.

4 pathways4 of 4 clocks verifiedvalidity Indefinite (re-registration on changes)MDSAP not acceptedreviewed 2026-08-25

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class 1(RZN state registration (EAEU route)) Staged VNIIMT expertise 25 wd; single 15-wd query round; sponsor response ≤35 wd excluded from the clock; conclusion 10 wd; RZN decision 5 wd; RU language check 5 wd; deficit-list checks ≤5 wd	31-50 working days	2-4 months	—	Verified
Class 2a(RZN state registration (EAEU route)) Staged VNIIMT expertise 25 wd; single 15-wd query round; sponsor response ≤35 wd excluded from the clock; conclusion 10 wd; RZN decision 5 wd	31-50 working days	3-5 months	—	Verified
Class 2b(RZN state registration (EAEU route)) Staged VNIIMT expertise 25 wd; single 15-wd query round; sponsor response ≤35 wd excluded from the clock; conclusion 10 wd; RZN decision 5 wd	31-50 working days	4-7 months	—	Verified
Class 3(RZN state registration (EAEU route)) Staged VNIIMT expertise 25 wd; single 15-wd query round; sponsor response ≤35 wd excluded from the clock; conclusion 10 wd; RZN decision 5 wd	31-50 working days	5-9 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Russia Medical Device Registration Process

Step-by-step RZN registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by RZN. Appoint a Russian Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to RZN including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

RZN reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

31-50 working days

In-depth technical assessment of device safety and performance. RZN may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, RZN issues Russia market authorization certificate.

Summary: The Russia medical device registration process through Federal Service for Surveillance in Healthcare (RZN) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Technical documentation and QMS evidence reuse1-3 months

FDA 510(k)/PMASubmission content reuse as reference evidence

Key requirements

Local Authorized Representative accredited in Russia (EAEU route)
EAEU technical/documentation expertise, including clinical and toxicological evidence for Class 2b/3
GOST-R/EAC marking after registration; national register entry (RZN) required before sale
Re-registration within 150 working days when substantive changes occur

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Source-linked review clocks verified against RZN publications · full review 2026-08-25 · row IDs are stable — cite as registration-timeline:russia:class-1