Ukraine medical device registration timeline
Source-linked clocksState Service of Ukraine on Medicines and Drug Control (SMDC) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU-aligned (Law 1207) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-declaration under Annex 8) §18 of the Technical Regulation: for a Class I device that is neither custom-made nor investigational, the manufacturer follows the Annex 8 procedure and draws up the declaration of conformity, and that alone lets the device be placed on the market — no body reviews it and no period runs | 0 days | 2-4 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesUkraine Medical Device Registration Process
Step-by-step SMDC registration process. Total estimated timeline: 2-4 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by SMDC. Appoint a Ukrainian Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to SMDC including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksSMDC reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. SMDC may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, SMDC issues Ukraine market authorization certificate.
- Local Authorized Representative (for foreign manufacturers)
- CE-marking-based registration route (Law No. 1207, as amended for martial law)
- Clinical investigations (§33): for Class III implantables and long-term invasive Class IIa and IIb devices the manufacturer may begin 60 calendar days after notifying Derzhliksluzhba unless a negative decision is communicated within that period, and earlier if the ethics commission approves the study programme
- Devices with an ancillary medicinal substance or human blood derivative: the MOH State Expert Centre opinion is issued within 210 calendar days of a complete document set
- English-language technical documentation accepted under wartime amendments
- The previously recorded 10-working-day state register entry could not be traced to the Technical Regulation, which contains no working-day periods at all, so it is not carried here
Reviewed 2026-08-29. End-to-end totals remain planning estimates.