BASG market access

Austria medical device registration resources

Research BASG registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Austria medical device resource.

4 free resourcesAug 2026 fees reviewed

Run the classification agent

Everything we track for Austria

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Austria requirements.

Medical device regulation news

Follow recent Federal Office for Safety in Health Care (BASG) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary BASG risk class with official rule references.

Government registration fees

Review current BASG application, review, and renewal fees.

Government fees

Full fee schedule (13 lines) →

BASG registration fees in EUR · reviewed 2026-08-25

Fee line	Amount	Provenance
Annual medical-device levy (Medizinprodukteabgabe) - Class I	EUR 250	Verified
Annual medical-device levy - Class IIa	EUR 300	Verified
Annual medical-device levy - Class IIb	EUR 350	Verified
Annual medical-device levy - Class III	EUR 400	Verified

9 more fee lines on the full schedule · 13 of 13 rows source-verified

Latest regulation news

All Austria regulation news →

Newest BASG-related headlines from the daily-refreshed feed — every row links to the publishing source.

Aug 26MGMedEnvoy GlobalWhat Is a Saudi Arabia Authorized Representative for Medical Devices?

Austria Aug 26OSOperon StrategistSFDA Medical Device Establishment License (MDEL): Complete Compliance Guide

Austria Aug 25MGMedEnvoy GlobalHow Does Mexico Classify Single-Use Versus Reusable Medical Devices?

Austria Aug 25FLFDA Law BlogFDA Addresses Device Constituents in New Draft Guidance on Container Closure Systems

Austria Aug 25PBPacific BridgeCan Foreign Clinical Data be Used to Get Your Medical Device Approved in Japan?

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Turn Austria research into practical work

The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.

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Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Austria work.

Austria market-launch workpaper

Connect the BASG route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Austria dossier reuse and delta

Compare an existing authorization and evidence set against BASG administrative, testing, labeling, and dossier needs.

Austria change notification workpaper

Map a product or manufacturing change to BASG evidence, notification, timing, and implementation questions.

Austria regulatory change impact

Assess a current BASG update against one product and turn it into an owner-ready action workpaper.

Austria cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Austria (BASG).

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Local representation, BASG submissions, and lifecycle maintenance — handled with an expert.