Liechtenstein medical device registration timeline
Source-linked clocksOffice of Public Health (Amt für Gesundheit) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU MDR (EEA) 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 estimatesLiechtenstein Medical Device Registration Process
Step-by-step Amt für Gesundheit 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 Amt für Gesundheit. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Amt für Gesundheit including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksAmt für Gesundheit reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. Amt für Gesundheit may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Amt für Gesundheit issues Liechtenstein market authorization certificate.
- EU/EEA Authorized Representative (for non-EEA manufacturers)
- Liechtenstein applies the EU MDR directly as an EEA member (Medical Devices Ordinance)
- Clinical investigation: 45-day authorisation (+20 with experts) per MDR Art. 70(6) as applied in the EEA
- Art. 74(1) PMCF investigations notified at least 30 days before start
Reviewed 2026-08-29. End-to-end totals remain planning estimates.