France medical device registration timeline
Source-linked clocksFrench National Agency for the Safety of Medicines and Health Products (ANSM) 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 estimatesFrance Medical Device Registration Process
Step-by-step ANSM 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 ANSM. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to ANSM including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksANSM reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. ANSM may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, ANSM issues France market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Clinical investigation: CPP ethics opinion within 45 days of validation (30 days for PMCF studies with additional invasive procedures) (Art. R1125-10 CSP); CPP silence means rejection
- Validation: 7-day admissibility check, 3 days to declare valid, 10 days sponsor remedy (+20)
- No ANSM-side authorisation deadline is fixed in the Code de la santé publique chapter on medical-device clinical investigations
Reviewed 2026-08-29. End-to-end totals remain planning estimates.