Belgium medical device registration timeline
Source-linked clocksFederal Agency for Medicines and Health Products (FAMHP) 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 estimatesBelgium Medical Device Registration Process
Step-by-step FAMHP 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 FAMHP. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to FAMHP including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksFAMHP reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. FAMHP may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, FAMHP issues Belgium market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Technical Documentation (Annex II & III)
- Clinical investigation: validation 10 days (Art. 31 RD 18 May 2021); sponsor completion 10 days (+20); ethics advice requested within 15 days of validation (Art. 32)
- Ministerial decision within 45 days of validation (+20 with experts) (Art. 34); ethics full-agreement opinion 45 days, local committees 25 days (Art. 36)
- National extensions as CMS: +20 days (Art. 70 §7(b) via Art. 16), +50 days (Art. 78 §4 for class IIb/III via Art. 17), +7 days (Art. 75 §3 via Art. 19)
Reviewed 2026-08-29. End-to-end totals remain planning estimates.