NNGYK market accessHungary medical device registration resources
Research NNGYK registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Hungary medical device resource.
Everything we track for Hungary
Browse by resource instead →Additional certification and licence checker
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Hungary requirements.
Medical device regulation news
Follow recent National Center for Public Health and Pharmacy (NNGYK) policy, guidance, safety, and compliance updates.
AI medical device classifier
Describe your device and get a preliminary NNGYK risk class with official rule references.
Government registration fees
Review current NNGYK application, review, and renewal fees.
Government fees
Full fee schedule (11 lines) →NNGYK registration fees in HUF · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| EUDAMED actor registration | HUF 97,065 | Verified |
| Custom-made-device manufacturer registration | HUF 8,100 | Verified |
| Conformity-assessment-body designation | HUF 167,000 | Verified |
| Certificate for aids for individual measures | HUF 189,000–508,950 | Verified |
Latest regulation news
All Hungary regulation news →Newest NNGYK-related headlines from the daily-refreshed feed — every row links to the publishing source.
HungaryAug 26OSOperon StrategistSFDA Medical Device Establishment License (MDEL): Complete Compliance GuideHungaryAug 25MGMedEnvoy GlobalHow Does Mexico Classify Single-Use Versus Reusable Medical Devices?HungaryAug 25FLFDA Law BlogFDA Addresses Device Constituents in New Draft Guidance on Container Closure SystemsHungaryAug 25PBPacific BridgeCan Foreign Clinical Data be Used to Get Your Medical Device Approved in Japan?HungaryTurn Hungary 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 Hungary work.
Hungary market-launch workpaper
Connect the NNGYK route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Hungary dossier reuse and delta
Compare an existing authorization and evidence set against NNGYK administrative, testing, labeling, and dossier needs.
Hungary change notification workpaper
Map a product or manufacturing change to NNGYK evidence, notification, timing, and implementation questions.
Hungary regulatory change impact
Assess a current NNGYK update against one product and turn it into an owner-ready action workpaper.
Hungary cybersecurity evidence review
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Hungary (NNGYK).
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