Romania medical device registration timeline
Source-linked clocksNational Agency for Medicines and Medical Devices (ANMDM) 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 estimatesRomania Medical Device Registration Process
Step-by-step ANMDM 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 ANMDM. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to ANMDM including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksANMDM reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. ANMDM may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, ANMDM issues Romania market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Economic-operator registration (EUDAMED transitional): decision within 60 days; actor ID issued within 15 days of EUDAMED reactivation
- Translation exemptions/derogations handled within 30 days
- Clinical investigation: submission validation 10 days, applicant clarification 10 days, re-validation 5 days (aligned with MDR Art. 70)
- Advertising: acknowledgement within 30 days, final decision within 60 days
Reviewed 2026-08-29. End-to-end totals remain planning estimates.