Lithuania medical device registration timeline
Source-linked clocksState Medicines Control Agency under the Ministry of Health (VVKT) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU MDR classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-certification (MDR) with national registration entry) National register entry published within 20 working days of a complete application (HSL iš Lietuvos Respublikos sveikatos apsaugos ministro įsakymas); EU MDR self-certification runs in parallel | 20 working days | 1-2 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesLithuania Medical Device Registration Process
Step-by-step VVKT registration process. Total estimated timeline: 1-2 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by VVKT. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to VVKT including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksVVKT reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
20 working daysIn-depth technical assessment of device safety and performance. VVKT may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, VVKT issues Lithuania market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- National Class I/IVD registration: register entry published within 20 working days; deficiencies must be cured within 30 days
- Class IIa/IIb/III distributors/manufacturers established in Lithuania notify VVKT within 14 working days
- Free-sale certificate issued within 20 working days