Legal basis & guidance by country

authority: State Institute for Drug Control (SÚKL) · submissionSurface: EUDAMED for MDR/IVDR actors/devices plus ISZP national notifications for specified roles · verifiedHighlights: The current national basis is Act No. 375/2022 Coll.; Distributors, service persons and custom made manufacturers have national ISZP notification duties.

authority: Danish Medicines Agency · submissionSurface: EUDAMED plus Danish national distributor/specialty retailer registration form · verifiedHighlights: From 28 May 2026, covered manufacturers, authorised representatives and importers register in EUDAMED.; Danish distributors and specialty retailers retain national registration duties.

authority: Federal Institute for Drugs and Medical Devices (BfArM) · submissionSurface: EUDAMED mandatory layer plus DMIDS transitional/special workflows · verifiedHighlights: BfArM publishes DMIDS access forms, instructions and special authorisation workflows.; The page documents the 28 May 2026 EUDAMED transition and states that automatic DMIDS transfer is unavailable.

authority: National Organization for Medicines (EOF) · submissionSurface: EUDAMED plus EOF national medical device register/forms for applicable national duties · verifiedHighlights: EOF publishes current medical device supporting documents and forms.; EOF separately maintains medical device notification, vigilance and distribution/production materials.

authority: National Center for Public Health and Pharmacy (NNGYK) · submissionSurface: EUDAMED shared layer; current national operational form/portal still requires extraction · verifiedHighlights: NNGYK's official tariff identifies national medical device registration, change and certificate services. · caveat: A current consolidated national device registration portal/form page was not located in this pass.

authority: Ministry of Health — Directorate General for Medical Devices and Pharmaceutical Service · submissionSurface: EUDAMED shared layer plus Italian BD/RDM national database workflows · verifiedHighlights: The Ministry publishes national database access, delegation, modification and help materials.; The same official hub exposes UDI, vigilance, import/export and open device data surfaces.

authority: Ministry of Health / Committee for Medical and Pharmaceutical Control · submissionSurface: Digital Government to e Licensing portal · verifiedHighlights: The official service covers registration, re registration and dossier amendments.; Its stated outputs include Kazakh and Russian language instructions, packaging and labels.

authority: Pharmacy and Poisons Board (PPB) · submissionSurface: PPB online services portal plus statutory Form 1 and dossier · verifiedHighlights: The current rules contain the application, local representative, dossier, variation, renewal, validity and fee structure.; Medical device certificates are valid for five years under the rules.

authority: Office of Public Health · submissionSurface: EUDAMED plus Liechtenstein notifications/forms for national and customs union edge cases · verifiedHighlights: The official page maps EEA MDR/IVDR registration to EUDAMED.; It separately describes custom made and IVD notifications and Liechtenstein's parallel EEA/Swiss market access context.

authority: CIBG/Farmatec; Health and Youth Care Inspectorate for supervision · submissionSurface: EUDAMED plus NOTIS for custom made and transition specific national notifications · verifiedHighlights: Farmatec's current page reflects mandatory EUDAMED device registration from 28 May 2026.; Custom made device and transition specific changes remain in NOTIS.

authority: Medsafe, Ministry of Health · submissionSurface: WAND online notification database · verifiedHighlights: New Zealand uses mandatory sponsor/device notification in WAND rather than general premarket approval.; WAND supports sponsor/device updates and requires post market records and corrective action reporting.

authority: National Agency for Food and Drug Administration and Control (NAFDAC) · submissionSurface: NAFDAC iRIMS stakeholder portal · verifiedHighlights: NAFDAC publishes distinct imported and locally made medical device registration guidelines.; Its iRIMS portal supports application, tracking and registration management.

authority: Norwegian Medical Products Agency (DMP/NOMA) · submissionSurface: EUDAMED · verifiedHighlights: Norway implements the EU device regulations through the EEA and now uses EUDAMED for device registration.; The official page includes the 28 November 2026 transition deadline for earlier devices.

authority: Ministry of Health — National Directorate of Medical Devices · submissionSurface: MINSA forms and procedures under Law 90 and implementing resolutions · verifiedHighlights: The Directorate's statutory surface covers product registration, establishment licensing, import permits, free sale certificates, labeling, traceability and vigilance.; MINSA publishes national medical device forms and the operative legal framework.

authority: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) · submissionSurface: EUDAMED plus current URPL national forms/notifications for specified routes · verifiedHighlights: URPL publishes four current device forms and filling instructions.; The official page distinguishes EUDAMED actor/device registration from remaining national notifications.

authority: INFARMED, I.P. · submissionSurface: EUDAMED shared layer plus INFARMED national licensing/notification surfaces · verifiedHighlights: INFARMED's official hub links device registration, licensing, guidance and searchable national device data. · caveat: Some national transition wording predates mandatory EUDAMED modules and requires a current delta check.

authority: National Agency for Medicines and Medical Devices of Romania (ANMDMR) · submissionSurface: EUDAMED plus ANMDMR national database forms and email/physical filing · verifiedHighlights: ANMDMR publishes Word/PDF forms for devices, IVDs, custom made devices and information changes.; The authority explicitly states that national database registration is not product approval.

authority: Agency for Medicinal Products and Medical Devices (JAZMP) · submissionSurface: EUDAMED shared layer plus JAZMP/SPOT national registration and forms · verifiedHighlights: JAZMP publishes separate sections for actor registration, device registration, forms, vigilance, clinical investigation and free sale certificates.; The current national basis includes the Medical Devices Act ZMedPri 1.

authority: Spanish Agency for Medicines and Medical Devices (AEMPS) · submissionSurface: EUDAMED plus RECOPS national commercialization registration from 15 June 2026 · verifiedHighlights: AEMPS launched RECOPS on 15 June 2026 and ended new filings in the former CCPS/RPS routes except specified custom made workflows.; RECOPS receives Spanish market commercialization information including labels and instructions.

authority: National Medicines Regulatory Authority (NMRA) · submissionSurface: NMRA online pre submission form plus physical dossier/checklists · verifiedHighlights: NMRA's current hub publishes registration, variation, waiver, low risk, forms, guidelines, fees and registered device lists.; Foreign manufacturers file through a Sri Lankan marketing authorization holder.

authority: Swedish Medical Products Agency · submissionSurface: EUDAMED for covered roles plus Swedish MPA registration for specified national categories · verifiedHighlights: The June 2026 update maps each actor/device category to EUDAMED or the Swedish national system.; The page also describes data update and annual fee obligations for covered national roles.

authority: Ministry of Health and State Service of Ukraine on Medicines and Drugs Control · submissionSurface: Conformity assessment and responsible person notification model rather than a universal product registration portal · verifiedHighlights: The official FAQ maps device classes to conformity assessment routes and responsible person registration.; Ukraine adopted new MDR/IVDR aligned technical regulations in June 2026; effective dates and transition rules must be attached before tool use.

authority: Ministry of Public Health — Medical Technology Evaluation Department · submissionSurface: VUCE/PIRM electronic transfer plus MSP product specific forms · verifiedHighlights: MSP publishes separate registration forms for diagnostic reagents, therapeutic devices and medical equipment.; The official surface includes registration/renewal, customs negative certificate and compassionate use procedures.

authority: State Center for Expertise and Standardization under the pharmaceutical sector authority · submissionSurface: Single Portal of Interactive Public Services (OneID) · verifiedHighlights: The official e government service exposes the state registration application, legal basis, fees and responsible authority.