HALMED market accessResearch HALMED registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Croatia medical device resource.
Describe your device and get a preliminary HALMED risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Croatia requirements.
Review current HALMED application, review, and renewal fees.
Compare official and realistic approval times by device class and pathway.
Browse Croatia's official medical-device instruments — the Act implementing EU MDR and IVDR, HALMED's fee scale for medical devices, and the EU regulations and Commission decision — with citeable Croatian and English passages.
Common questions about changing a registered medical device in Croatia. Each question separates published rules from details still awaiting verification.
22 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-16
No source-verified answer is published for this dimension yet.
HALMED registration fees in EUR · reviewed 2026-09-16
| Fee line | Amount | Provenance |
|---|---|---|
| Entry in the register of manufacturers or authorised representatives (Upis / uskraćivanje upisa u očevidnik proizvođača ili zastupnika proizvođača) | EUR 700.00 | Verified |
| Change of an entry in the register of manufacturers or authorised representatives (Izmjena / uskraćivanje izmjene upisa) | EUR 200.00 | Verified |
| Entry in the register of medical devices, 1 to 5 products | EUR 800.00 | Verified |
| Entry in the register of medical devices, 6 to 30 products | EUR 900.00 | Verified |
Agencija za lijekove i medicinske proizvode (HALMED) (HALMED) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification
| Class / pathway | Review clock | Planning total | 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 Elapsed time is EUDAMED actor and device registration plus HALMED's register entry under NN 100/2018, neither of which has a guaranteed processing time | 0 days | 6-9 months | Verified |
| HALMED decision on entry in the register of distributors(National administrative decision under NN 100/2018 Article 9(2)) This is the national competent-authority clock, not a conformity-assessment clock: 'Rješenje o upisu u registar distributera donosi Agencija u roku od 30 dana od dana dostave urednog zahtjeva' The clock runs from delivery of a complete request, so it does not start while the Agency is waiting for supplements, which is why the realistic range is wider than the published period Against the decision no appeal lies; an administrative dispute may be initiated (Article 29(2)) | 30 days | 30-60 days | Verified |
| HALMED decision on a classification dispute between a manufacturer and a notified body(National administrative decision under NN 100/2018 Article 11(3)-(4)) Article 11(3)-(4) of NN 100/2018 gives HALMED the decision where a manufacturer and a notified body disagree over the application of the classification rules; Article 11(3) sets 30 days from receipt of a complete request and Article 11(4) extends the period by 15 days where supplements are requested, so the published period is 30 to 45 days This is a dispute-resolution clock for a national administrative act, not a route onto the market: the Union class itself remains the manufacturer's determination under MDR Annex VIII, and HALMED's own risk-classification service is a paid opinion on its price list | 30-45 days | 30-45 days | Verified |
Official HALMED rules and guidance · 6 of 6 documents linked to official sources
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting Croatia work.
Connect the HALMED route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against HALMED administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to HALMED evidence, notification, timing, and implementation questions.
Assess a current HALMED update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Croatia (HALMED).
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