AEMPS market accessSpain medical device registration resources
Research AEMPS registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Spain medical device resource.
Everything we track for Spain
Browse by resource instead →Medical device regulation news
Follow recent Spanish Agency for Medicines and Medical Devices (AEMPS) policy, guidance, safety, and compliance updates.
AI medical device classifier
Describe your device and get a preliminary AEMPS risk class with official rule references.
Government registration fees
Review current AEMPS application, review, and renewal fees.
Government fees
Full fee schedule (10 lines) →AEMPS registration fees in EUR · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| Registration/communication of medical devices (code 5.01) | EUR 99.71 | Verified |
| Prior operating licence - manufacturing, sterilisation, reprocessing establishments (code 5.17) | EUR 983.85 | Verified |
| Manufacturing-licence modification/revalidation (code 5.19) | EUR 983.85 | Verified |
| Prior operating licence - import and grouping establishments (code 5.18) | EUR 491.92 | Verified |
Latest regulation news
All Spain regulation news →Newest AEMPS-related headlines from the daily-refreshed feed — every row links to the publishing source.
SpainAug 26OSOperon StrategistSFDA Medical Device Establishment License (MDEL): Complete Compliance GuideSpainAug 25MGMedEnvoy GlobalHow Does Mexico Classify Single-Use Versus Reusable Medical Devices?SpainAug 25FLFDA Law BlogFDA Addresses Device Constituents in New Draft Guidance on Container Closure SystemsSpainAug 25PBPacific BridgeCan Foreign Clinical Data be Used to Get Your Medical Device Approved in Japan?SpainTurn Spain research into practical work
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Build a reusable product master
Structure company, product, model, approval, certificate, and evidence facts before starting Spain work.
Spain market-launch workpaper
Connect the AEMPS route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Spain dossier reuse and delta
Compare an existing authorization and evidence set against AEMPS administrative, testing, labeling, and dossier needs.
Spain change notification workpaper
Map a product or manufacturing change to AEMPS evidence, notification, timing, and implementation questions.
Spain regulatory change impact
Assess a current AEMPS update against one product and turn it into an owner-ready action workpaper.
Spain cybersecurity evidence review
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Spain (AEMPS).
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