Bulgaria medical device registration timeline
Source-linked clocksBulgarian Drug Agency (BDA) 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-declaration (no notified body)) MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock | 0 days | 6-9 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesBulgaria Medical Device Registration Process
Step-by-step BDA registration process. Total estimated timeline: 6-9 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by BDA. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to BDA including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksBDA reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. BDA may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, BDA issues Bulgaria market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Class I national registration application due within 14 days of placing on the market (Art. 27(1) ЗМИ); IVD registration within 14 days (Art. 28(6)); changes within 14 days (Art. 28(7))
- Clinical investigation authorisation assessed within 60 days (Art. 51(1)) with stop-clock (51(3)); tacit start if no decision (51(8)); refused applications remediable within 30 days (51(5)); final report within 90 days of completion (Art. 57(1))
- Wholesale permit decided within 30 days (Art. 79(2)) with stop-clock (79(3)); EEA trader entries 7 days (79(4))
Reviewed 2026-08-29. End-to-end totals remain planning estimates.