Pure Global AI
Regulatory comparison

Medical Device Government Fees 2026

Current official registration-fee evidence for 105 markets. Exact amounts convert to USD; dynamic tariffs, quotes, and unpublished amounts remain explicitly non-numeric.

105 markets1,006 fee lines100% exact amountsreviewed Sep 16, 2026
MarketFee lineOfficial amountUSD equivalentFrequencyProvenance
Albania flagAlbania
AKBPM
Medical-device registration applicationALL 500$6.20Per applicationVerified
Algeria flagAlgeria
ANPP
Homologation (marketing-authorisation) modificationDZD 150,000$1,118Per modificationVerified
Homologation renewalDZD 300,000$2,235Per renewalVerified
Transfer of homologation to another holderDZD 100,000$745Per transferVerified
Pharmaceutical-establishment file expertiseDZD 300,000$2,235Per fileVerified
Argentina flagArgentina
ANMAT
Registration - Class I/II familyARS 500,220$336Per applicationVerified
Registration - Class III/IV familyARS 824,985$554Per applicationVerified
IVD Registration - Class A/BARS 445,725$299Per applicationVerified
IVD Registration - Class C/DARS 564,165$379Per applicationVerified
Manufacturer/importer authorization including GMP and technical directorARS 1,880,550$1,263Per authorizationVerified
Foreign plant GMP verificationARS 11,799,000 + travel$7,926Per main plantVerified
Armenia flagArmenia
Ministry of Health of the Republic of Armenia
State registration of a class 1 medical deviceAMD 10,000$27.51Per device, per registrationVerified
State registration of a class 2 medical deviceAMD 20,000$55.02Per device, per registrationVerified
State registration of a class 3 medical deviceAMD 30,000$82.53Per device, per registrationVerified
State registration of an in vitro diagnostic medical deviceAMD 20,000$55.02Per device, per registrationVerified
Re-issuance of a registration certificate for changes not affecting safety, effectiveness or quality (point 35 heading covers medicines, pharmaceutical products and medical devices)AMD 5,000$13.75Per re-issued certificateVerified
Certificate of the right to perform conformity attestationAMD 24,000$66.02Per certificateVerified
Australia flagAustralia
TGA
Annual Charge - Class I (other)AUD 121$85.68Annual per ARTG entryVerified
Annual Charge - Class I (measuring/sterile)AUD 879$622Annual per ARTG entryVerified
Annual Charge - Class IIa/IIbAUD 1,305$924Annual per ARTG entryVerified
Annual Charge - Class III/AIMDAUD 1,662$1,177Annual per ARTG entryVerified
Application Fee - Class IAUD 651$461Per ARTG inclusion applicationVerified
Application Fee - Class IIa/IIbAUD 1,244$881Per ARTG inclusion applicationVerified
Application Fee - Class IIIAUD 1,603$1,135Per ARTG inclusion applicationVerified
IVD Annual ChargeAUD 948$671Annual per ARTG entryVerified
IVD Application FeeAUD 1,244$881Per ARTG inclusion applicationVerified
UDI Consent to Supply application - first ARTG entryAUD 80$56.65Per applicationVerified
UDI Consent to Supply - each additional ARTG entry in the same applicationAUD 10$7.08Per additional entryVerified
Austria flagAustria
BASG
Annual medical-device levy (Medizinprodukteabgabe) - Class IEUR 250$289Per yearVerified
Annual medical-device levy - Class IIaEUR 300$347Per yearVerified
Annual medical-device levy - Class IIbEUR 350$405Per yearVerified
Annual medical-device levy - Class IIIEUR 400$463Per yearVerified
Default official-act assessment fee (administrative charge plus VAT)EUR 433$501Per official actVerified
Clinical-investigation application (MDR Art. 62/70)EUR 3,036–8,352$3,511–$9,660Per applicationVerified
Clinical-investigation notification (CE-marked device, MDR Art. 74)EUR 2,278–5,315$2,635–$6,147Per notificationVerified
Clinical-investigation post-market/report reviewEUR 949$1,098Per reviewVerified
Substantial change to a clinical investigationEUR 1,392$1,610Per changeVerified
Authority inspectionEUR 1,709$1,977Per half-dayVerified
IVD performance-study application (IVDR Art. 58/66)EUR 2,278–4,036$2,635–$4,668Per applicationVerified
IVD performance-study notification (CE-marked IVD)EUR 949–2,278$1,098–$2,635Per notificationVerified
Free-sale certificateEUR 660–1,253$763–$1,449Per certificateVerified
Bahrain flagBahrain
NHRA
Application to submit a medical device registrationBHD 5$13.30Each applicationVerified
Medical Device & Supplies traceability feeBHD 5$13.30Each individual deviceVerified
Low risk medical device registration or renewalBHD 150$399Every 3 years per licenceVerified
Medium risk medical device registration or renewalBHD 300$798Every 3 years per licenceVerified
High risk medical device registration or renewalBHD 1,000$2,660Every 3 years per licenceVerified
Update medical device registration dataBHD 20$53.19Each deviceVerified
Authorized Representative licence application feeBHD 50$133Each new orderVerified
Authorized Representative licence, Class A — first licenceBHD 1,000$2,660First licenceVerified
Authorized Representative licence, Class A — renewalBHD 700$1,862AnnualVerified
Authorized Representative licence, Class B — first licenceBHD 700$1,862First licenceVerified
Authorized Representative licence, Class B — renewalBHD 500$1,330AnnualVerified
Authorized Representative licence, Class C — first licenceBHD 500$1,330First licenceVerified
Authorized Representative licence, Class C — renewalBHD 300$798AnnualVerified
Authorized Representative licence, Class D — first licenceBHD 300$798First licenceVerified
Authorized Representative licence, Class D — renewalBHD 200$532AnnualVerified
Medical devices warehouse licensing — first licenceBHD 1,000$2,660First licenceVerified
Medical devices warehouse licensing — renewalBHD 800$2,128AnnualVerified
Medical devices manufacturer licensing — first licenceBHD 5,000$13,298First licenceVerified
Medical devices manufacturer licensing — renewalBHD 3,000$7,979AnnualVerified
Update medical device facilities dataBHD 50$133Each requestVerified
Re-inspection of medical device facilitiesBHD 50$133Each requestVerified
Request approval to import a single registered medical deviceBHD 0.500$1.33Each typeVerified
Request approval to import a single unregistered medical deviceBHD 2$5.32Each typeVerified
Request approval to import a single registered IVD or combined medical deviceBHD 1$2.66Each typeVerified
Request approval to import a single unregistered IVD or combined medical deviceBHD 3$7.98Each typeVerified
Verify the validity of the quality certificateBHD 5$13.30Each typeVerified
Product classification request — regularBHD 20$53.19Each typeVerified
Product classification request — urgentBHD 40$106Each typeVerified
Demurrage for the device until approvalBHD 100$266Per day per shipmentVerified
Issuing a product classification certificateBHD 15$39.89Each certificateVerified
Sample examinationBHD 5$13.30Each typeVerified
Inspecting the shipment at the portBHD 10$26.60Each typeVerified
Submit a request for approval to use the device — permit to use deviceBHD 0.500$1.33Each deviceVerified
Evaluate the viability of the productBHD 50$133Each deviceVerified
Issuing certificates for medical manufacturer and devices, free sale and other paper documentsBHD 10$26.60Each requestVerified
Product disposal supervisingBHD 25$66.49Each requestVerified
Bangladesh flagBangladesh
DGDA
Preliminary registration ("recipe") approval for import of a drug, medical device or IVD reagentBDT 5,000 (BDT 5,750 with VAT)$40.71Per applicationVerified
Grant of import registration (registration and analysis fee)BDT 50,000 (BDT 57,500 with VAT)$407Per registrationVerified
Renewal of import registrationBDT 10,000 (BDT 11,500 with VAT)$81.43Every 5 yearsVerified
Belarus flagBelarus
Ministry of Health / RCETH
National registration state duty and expert charges10 base units (BYN 450 in 2026) + expert fees—Check before submissionOfficial source
Belgium flagBelgium
FAMHP
Annual fee per device-sector entity (manufacturer, importer, distributor, AR)EUR 424.54$491Per yearVerified
Free-sale certificateEUR 297.85$344Per certificateVerified
Bolivia flagBolivia
AGEMED
Dispositivo médico importado — Servicio por Registro Sanitario, InscripciónBOB 1,489$125Per registrationVerified
Dispositivo médico importado — Servicio por Registro Sanitario, ReinscripciónBOB 1,117$94.09Per reinscription, every 5 yearsVerified
Dispositivo médico Nacional — Servicio por Registro Sanitario, InscripciónBOB 993$83.65Per registrationVerified
Dispositivo médico Nacional — Servicio por Registro Sanitario, ReinscripciónBOB 745$62.76Per reinscription, every 5 yearsVerified
Reactivo para diagnóstico nacional — Servicio por Registro Sanitario, InscripciónBOB 621$52.31Per registrationVerified
Reactivo para diagnóstico importado — Servicio por Registro Sanitario, InscripciónBOB 1,241$105Per registrationVerified
Prótesis o implante importado — Servicio por Registro Sanitario, InscripciónBOB 1,737$146Per registrationVerified
Prótesis o implante nacional — Servicio por Registro Sanitario, InscripciónBOB 869$73.20Per registrationVerified
Rectificación de Registro Sanitario, cualquiera sea el producto, nacional o importado, incluido dispositivo médico importadoBOB 621$52.31Per rectificationVerified
Segunda evaluación para Registro Sanitario, por falta de uno de los requisitos establecidosBOB 621$52.31Per re-entry of an observed dossierVerified
Evaluación de desempeño para reactivo de diagnóstico cuando corresponda, sea nacional o importadoBOB 1,241$105Per performance evaluationVerified
Firmas Importadoras de Dispositivos Médicos — Evaluación e Inspección por aperturaBOB 4,964$418Per establishment openingVerified
Firmas Importadoras de Dispositivos Médicos — Inspección anualBOB 1,241$105AnnualVerified
Bosnia and Herzegovina flagBosnia and Herzegovina
ALMBiH
Entry in the Register of medical devices, Class I — up to 25 products by protected or generic name in the applicationBAM 200$118Per individual product in the application, tiered by the number of namesVerified
Entry in the Register of medical devices, Class I — over 100 products by protected or generic name in the applicationBAM 100$58.99Per individual product in the application, tiered by the number of namesVerified
Entry in the Register of medical devices, Classes IIa and IIb — up to 25 products by protected or generic name in the applicationBAM 400$236Per individual product in the application, tiered by the number of namesVerified
Entry in the Register of medical devices, Classes IIa and IIb — over 100 products by protected or generic name in the applicationBAM 300$177Per individual product in the application, tiered by the number of namesVerified
Entry in the Register of medical devices, Class III — up to 15 products by protected or generic name in the applicationBAM 700$413Per individual product in the application, tiered by the number of namesVerified
Entry in the Register of medical devices, Class III — over 15 products by protected or generic name in the applicationBAM 500$295Per individual product in the application, tiered by the number of namesVerified
Entry in the Register of medical devices, in vitro diagnostic devices — up to 25 products by protected or generic name in the applicationBAM 200$118Per individual product in the application, tiered by the number of namesVerified
Entry in the Register of medical devices, active implantable devices — up to 10 products by protected or generic name in the applicationBAM 800$472Per individual product in the application, tiered by the number of namesVerified
Entry in the Register of medical devices, active implantable devices — over 25 products by protected or generic name in the applicationBAM 500$295Per individual product in the application, tiered by the number of namesVerified
Amendment of an entry in the Register of medical devicesBAM 200$118Per requestVerified
Supplement of an entry in the Register of medical devicesBAM 200$118Per requestVerified
Expert opinion relating to a medical deviceBAM 100$58.99Per opinionVerified
Issue of a certificate of conformity for a medical deviceBAM 1,000$590Per certificateVerified
Decision on a request to classify a medical deviceBAM 200$118Per requestVerified
Authorisation for a clinical investigation of a medical deviceBAM 3,000$1,770Per authorisationVerified
Certificate of the existence and duration of an entity permit linked to an entry in the Register of medical devicesBAM 300$177Per certificateVerified
Administrative fee stamped on each request form submitted to the AgencyBAM 20$11.80Per request formVerified
Brazil flagBrazil
ANVISA
Class I/II notification (fato gerador 752)BRL 175.72–3,514.32$33.89–$678Per notificationVerified
Class III/IV registration — medium/small device (731)BRL 780.96–15,619.20$151–$3,013Per registrationVerified
Class III/IV registration — medium/small family (733)BRL 1,063.74–21,274.80$205–$4,104Per family registrationVerified
Class III/IV registration — large equipment (730)BRL 1,952.40–39,048.00$377–$7,532Per registrationVerified
Class III/IV registration — large-equipment family (732)BRL 2,482.06–49,641.20$479–$9,575Per family registrationVerified
Registration renewal — medium/small device (735)BRL 702.86–14,057.28$136–$2,711Per renewalVerified
Registration renewal — medium/small family (736)BRL 957.37–19,147.32$185–$3,693Per family renewalVerified
Registration renewal — large equipment (734)BRL 1,757.16–35,143.20$339–$6,779Per renewalVerified
Registration renewal — large-equipment family (737)BRL 2,233.85–44,677.08$431–$8,618Per family renewalVerified
Post-registration change or inclusion (738)BRL 175.72–3,514.32$33.89–$678Per petitionVerified
GMP certification — Brazil or Mercosur site (726)BRL 1,329.68–26,593.50$256–$5,129Per site and production lineVerified
GMP certification — site outside Mercosur (727)BRL 72,804.90$14,043Per site and production lineVerified
Bulgaria flagBulgaria
BDA
Class I device registration (single device)EUR 255.65$296Per deviceVerified
Class I device registration (group of devices)EUR 281.21–1,227.10$325–$1,419Per groupVerified
Custom-made device registration (single device)EUR 25.56$29.56Per deviceVerified
IVD List A/B registration (single device)EUR 204.52$237Per deviceVerified
Change to a registered Class I deviceEUR 127.82$148Per changeVerified
Clinical-investigation permit assessmentEUR 1,533.88$1,774Per applicationVerified
Wholesale-activity certificateEUR 1,533.88$1,774Per certificateVerified
Wholesale permit (import/export/distribution)EUR 2,556.46$2,957Per permitVerified
Canada flagCanada
Health Canada
MDL Application - Class IICAD 643$463Per applicationVerified
MDL Application - Class IIICAD 14,163$10,209Per applicationVerified
MDL Application - Class III near-patient IVDCAD 30,169$21,747Per applicationVerified
MDL Application - Class IVCAD 30,713$22,139Per applicationVerified
Private-label device applicationCAD 179$129Per applicationVerified
Annual right to sell - Class II/III/IVCAD 460$332Annual per licensed deviceVerified
Medical Device Establishment LicenceCAD 5,519$3,978Per application; same fee for annual review and reinstatementVerified
Amendment - Class II licenceCAD 331$239Per amendmentVerified
Amendment - Class III/IV changes in manufacturingCAD 4,470$3,222Per amendmentVerified
Amendment - Class III significant changes not related to manufacturingCAD 11,369$8,195Per amendmentVerified
Amendment - Class IV significant changes not related to manufacturingCAD 16,251$11,714Per amendmentVerified
Chile flagChile
ISP/ANDIM
Registration dossier review (item 9100002)CLP 487,880$510Per dossierVerified
Registration authorization (item 9100003)CLP 165,628$173Per authorizationVerified
Company inscription (item 9100016)CLP 311,935$326Per companyVerified
Registration modification (item 9100017)CLP 69,321$72.44Per modificationVerified
DMDIV (HIV) registration (item 9100018)CLP 5,776,551$6,036Per registrationVerified
DMDIV (HIV) authorization (item 9100019)CLP 487,880$510Per authorizationVerified
Export certificate (item 9200001)CLP 71,022$74.22Per certificateVerified
Warehouse authorization (item 9200007)CLP 911,573$953Per authorizationVerified
Stock-exhaustion authorization (item 9200010)CLP 80,872$84.51Per authorizationVerified
Technovigilance inscription (item 9500000)CLP 71,948$75.19Per inscriptionVerified
Technovigilance modification (item 9500001)CLP 39,456$41.23Per modificationVerified
China flagChina
NMPA
Imported Class I filingCNY 0$0Per filingVerified
Imported Class II registrationCNY 210,900$31,218Per registrationVerified
Imported Class II change registration (变更注册)CNY 42,000$6,217Per registrationVerified
Imported Class II renewal registration (延续注册)CNY 40,800$6,039Per renewalVerified
Imported Class III registrationCNY 308,800$45,710Per registrationVerified
Imported Class III change registration (变更注册)CNY 50,400$7,460Per registrationVerified
Imported Class III renewal registration (延续注册)CNY 40,800$6,039Per renewalVerified
Domestic Class III first registration (境内第三类首次注册)CNY 153,600$22,736Per registrationVerified
Domestic Class III change registrationCNY 50,400$7,460Per registrationVerified
Domestic Class III renewal registration (国产第三类延续注册)CNY 40,800$6,039Per renewalVerified
Clinical-trial application - high-risk medical device (domestic and import Class III)CNY 43,200$6,395Per applicationVerified
Colombia flagColombia
INVIMA
MD Application - Class ICOP 3,898,330$1,242Per productVerified
MD Application - Class IIaCOP 3,898,330$1,242Per productVerified
MD Application - Class IIbCOP 4,412,400$1,406Per productVerified
MD Application - Class IIICOP 4,412,400$1,406Per productVerified
IVD Application - Class I/IICOP 2,570,590$819Per productVerified
IVD Application - Class IIICOP 3,427,372$1,092Per productVerified
Commercialization or renewal permit - controlled-technology biomedical equipment (código 3005)COP 4,455,511$1,420Per permitVerified
Costa Rica flagCosta Rica
MOH
MD Registration - Class IUSD 0$0Per registrationVerified
MD Registration - Class II$25$25.00Per registrationVerified
MD Registration - Class III$50$50.00Per registrationVerified
MD Registration - Class IV$50$50.00Per registrationVerified
Côte d'Ivoire flagCôte d'Ivoire
AIRP (Autorité Ivoirienne de Régulation Pharmaceutique)
Prior declaration (listing) of medical devices and DMDIV, any classXOF 10,000$17.59Per productVerified
Marketing authorisation (Autorisation de Commercialisation) — Class A device, registration (redevance de base)XOF 50,000$87.95Per productVerified
Marketing authorisation — Class B device, registration (redevance de base)XOF 250,000$440Per productVerified
Marketing authorisation — Class C device, registration (redevance de base)XOF 500,000$879Per productVerified
Marketing authorisation — Class D device, registration (redevance de base)XOF 1,000,000$1,759Per productVerified
Marketing authorisation — DMDIV, registration (redevance de base)XOF 2,500,000$4,397Per productVerified
Marketing authorisation — Class A device, major variationXOF 50,000$87.95Per variationVerified
Marketing authorisation — Class B device, major variationXOF 250,000$440Per variationVerified
Marketing authorisation — Class C device, major variationXOF 500,000$879Per variationVerified
Marketing authorisation — Class D device, major variationXOF 1,000,000$1,759Per variationVerified
Marketing authorisation — DMDIV, major variationXOF 2,500,000$4,397Per variationVerified
Marketing authorisation — Class A device, minor variationXOF 10,000$17.59Per variationVerified
Marketing authorisation — Class B device, minor variationXOF 25,000$43.97Per variationVerified
Marketing authorisation — Class C device, minor variationXOF 50,000$87.95Per variationVerified
Marketing authorisation — Class D device, minor variationXOF 100,000$176Per variationVerified
Marketing authorisation — DMDIV, minor variationXOF 250,000$440Per variationVerified
Marketing authorisation — Class A device, renewal (renouvellement)XOF 25,000$43.97Per product, every 5 yearsVerified
Marketing authorisation — Class B device, renewal (renouvellement)XOF 125,000$220Per product, every 5 yearsVerified
Marketing authorisation — Class C device, renewal (renouvellement)XOF 250,000$440Per product, every 5 yearsVerified
Marketing authorisation — Class D device, renewal (renouvellement)XOF 500,000$879Per product, every 5 yearsVerified
Marketing authorisation — DMDIV, renewal (renouvellement)XOF 1,250,000$2,199Per product, every 5 yearsVerified
Declaration of medical-biology laboratory reagentsXOF 10,000$17.59Per productVerified
Croatia flagCroatia
HALMED
Entry in the register of manufacturers or authorised representatives (Upis / uskraćivanje upisa u očevidnik proizvođača ili zastupnika proizvođača)EUR 700.00$810Per applicationVerified
Change of an entry in the register of manufacturers or authorised representatives (Izmjena / uskraćivanje izmjene upisa)EUR 200.00$231Per applicationVerified
Entry in the register of medical devices, 1 to 5 productsEUR 800.00$925Per applicationVerified
Entry in the register of medical devices, 6 to 30 productsEUR 900.00$1,041Per applicationVerified
Entry in the register of medical devices, more than 30 productsEUR 1,000.00$1,157Per applicationVerified
Change of an entry in the register of medical devices (Izmjena upisa u očevidnik medicinskih proizvoda)EUR 300.00$347Per applicationVerified
Risk classification of a medical device (Razvrstavanje medicinskog proizvoda s obzirom na klasu rizika)EUR 1,000.00 plus the cost of an external expert where one is engaged$1,157Per requestVerified
Issue of the Single Registration Number (SRN broj) by enterprise sizeEUR 400.00 (micro), EUR 600.00 (small), EUR 800.00 (medium or large)$463Per issueVerified
Free-sale certificate for one country (Potvrda o slobodnoj prodaji za jednu zemlju)EUR 150.00 to EUR 380.00$173Per country and per applicationVerified
Entry in the register of distributors (Upis / uskraćivanje upisa u registar distributera)EUR 400.00 to EUR 1,050.00$463Per applicationVerified
Maintenance of medical device status for manufacturers and authorised representatives established in CroatiaEUR 200.00 to EUR 800.00$231Per maintenance period (period not stated in the price list)Verified
Change of the person responsible for regulatory compliance in EUDAMED (Izmjena osobe odgovorne za usklađenost s propisima u Eudamedu)EUR 100.00$116Per changeVerified
Derogation from the conformity assessment procedures under Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746EUR 1,000.00$1,157Per applicationVerified
Issue of the certificate of receipt of the notification of placing on the market (Izdavanje potvrde primitka obavijesti o stavljanju u promet)EUR 100.00$116Per certificateVerified
Cuba flagCuba
CECMED
Registration - Class I, high complexityCUP 26,370$1,099Per deviceVerified
Registration - Class I, low complexityCUP 21,340$889Per deviceVerified
Registration - Class IIa, high complexityCUP 32,910$1,371Per deviceVerified
Registration - Class IIa, low complexityCUP 28,885$1,204Per deviceVerified
Registration - Class IIb, high complexityCUP 34,920$1,455Per deviceVerified
Registration - Class IIb, low complexityCUP 33,405$1,392Per deviceVerified
Registration - Class III, high complexityCUP 38,945$1,623Per deviceVerified
Renewal - Class I, high complexityCUP 15,220$634Per device renewalVerified
Renewal - Class I, low complexityCUP 12,805$534Per device renewalVerified
Renewal - Class IIa, high complexityCUP 19,745$823Per device renewalVerified
Renewal - Class IIa, low complexityCUP 17,330$722Per device renewalVerified
Renewal - Class IIb, high complexityCUP 20,950$873Per device renewalVerified
Renewal - Class IIb, low complexityCUP 20,045$835Per device renewalVerified
Renewal - Class III, high complexityCUP 23,365$974Per device renewalVerified
Czech Republic flagCzech Republic
SÚKL
Custom-made-device manufacturer start-of-activity notificationCZK 3,000$139Per notificationVerified
Distributor start-of-activity notificationCZK 3,000$139Per notificationVerified
Service-person start-of-activity notificationCZK 3,000$139Per notificationVerified
Restoration of invalidated registration dataCZK 1,500$69.60Per restorationVerified
Clinical-investigation / performance-study authorizationCZK 1,000$46.40Per applicationVerified
Free-sale certificateCZK 1,000$46.40Per certificateVerified
SRN (EUDAMED actor) verificationCZK 3,000$139Per verificationVerified
Denmark flagDenmark
Danish Medicines Agency
Distributor/importer registrationDKK 1,238$192Per registrationVerified
Manufacturer/authorised-representative registrationDKK 1,234$191Per registrationVerified
Annual supervision fee - manufacturers/AR of low-risk productsDKK 6,298–56,682$977–$8,791Per yearVerified
Annual supervision fee - manufacturers/AR of medium/high-risk productsDKK 32,403–291,639$5,026–$45,233Per yearVerified
Annual supervision fee - importers/distributors of Class I devicesDKK 5,416–48,745$840–$7,560Per yearVerified
Annual supervision fee - importers/distributors of Class IIa–III devicesDKK 27,448–247,027$4,257–$38,314Per yearVerified
Decision in a classification dispute (MDR Art. 51(2) request)DKK 14,599$2,264Per decisionVerified
Opinion on a Class IIa/IIb conformity route (MDR Art. 52(9))DKK 78,590$12,189Per opinionVerified
Clinical-investigation application (non-implant, Class I–IIa)DKK 46,835$7,264Per applicationVerified
Clinical-investigation application (implantable, Class III, AIMD)DKK 62,947$9,763Per applicationVerified
Clinical investigation of a device without medical purpose (Annex XVI)DKK 59,135–79,479$9,172–$12,327Per applicationVerified
Clinical-investigation substantial modificationDKK 10,364$1,607Per modificationVerified
Annual supervision of an ongoing clinical investigationDKK 13,069$2,027Per yearVerified
IVD performance-study applicationDKK 54,127$8,395Per applicationVerified
Ethics-committee application (clinical investigation)DKK 18,275$2,834Per applicationVerified
Export certificateDKK 1,247$193Per certificateVerified
Dominican Republic flagDominican Republic
DIGEMAPS
Registro Sanitario de Productos Sanitarios — procedimiento simplificado, nuevo registroDOP 18,000$306Per registrationVerified
Registro Sanitario de Productos Sanitarios — procedimiento simplificado, renovaciónDOP 18,000$306Per renewalVerified
Autorización de publicidad y promoción (productos sanitarios)DOP 1,000$16.98Per brand or product, per authorisationVerified
Ecuador flagEcuador
ARCSA
Domestic medical-device registrationUSD 678.30$678Per registrationVerified
Foreign medical-device registrationUSD 904.34$904Per registrationVerified
Domestic medical-device re-registration (reinscripción)USD 135.66$136Per re-registration; 20% of the registration amountVerified
Foreign medical-device re-registration (reinscripción)USD 180.87$181Per re-registration; 20% of the registration amountVerified
Domestic registration modificationUSD 67.83$67.83Per modification; 10% of the registration amountVerified
Foreign registration modificationUSD 90.43$90.43Per modification; 10% of the registration amountVerified
Egypt flagEgypt
EDA
Registration application - locally produced medical deviceEGP 5,000$99.45Per applicationVerified
Registration application - imported medical deviceEGP 7,000$139Per applicationVerified
Import permit - invoice value under EGP 10,000EGP 500$9.95Per permitVerified
Import permit - invoice value EGP 10,000–50,000EGP 1,000$19.89Per permitVerified
Import permit - invoice value over EGP 50,000EGP 2,000$39.78Per permitVerified
Estonia flagEstonia
Ravimiamet
Notification of the first distribution of a device on the Estonian market (MSS § 26(4)) and submission of data to the medical devices and aids database (MSS § 29)EUR 0$0Per notification and per registrationVerified
Review of an application to conduct a clinical investigation of a medical device, or a performance study of an in vitro diagnostic medical deviceEUR 210.00$243Per applicationVerified
Free-sale certificate (vabamüügi sertifikaat) issued within 45 days of applicationEUR 154.00$178Per certificateVerified
Duplicate of a free-sale certificateEUR 32.00$37.01Per duplicateVerified
Free-sale certificate issued within five working days of application, at the applicant's requestEUR 308.00$356Per certificateVerified
Review of an application for designation as a conformity assessment bodyEUR 2,590.00$2,996Per applicationVerified
Notification of a notified body's designation and issue of its operating licenceEUR 777.00$899Per notificationVerified
Review of an application for a national type-approval certificate for a measuring instrument (riigisisese tüübikinnitustunnistuse taotluse läbivaatamine)EUR 240.00$278Per applicationVerified
Ethiopia flagEthiopia
EFDA
New application screeningETB 350$2.16Per applicationVerified
New application evaluationETB 1300$8.04Per applicationVerified
Renewal application evaluationETB 870$5.38Per renewal applicationVerified
Major variation application evaluationETB 870$5.38Per variation applicationVerified
Minor variation application evaluationETB 650$4.02Per variation applicationVerified
European Union flagEuropean Union
EMA / national competent authorities
EMA consultation - ancillary medicinal substance not previously evaluatedEUR 114,700$132,660Per consultationVerified
EMA consultation - ancillary medicinal substance previously evaluatedEUR 57,200$66,156Per consultationVerified
EMA consultation - change to an ancillary medicinal substanceEUR 5,000$5,783Per consultationVerified
EMA consultation - absorbed or locally dispersed substance-based deviceEUR 86,100$99,582Per consultationVerified
EMA consultation - companion diagnosticEUR 56,500$65,347Per consultationVerified
EMA consultation - change affecting a companion diagnosticEUR 5,000$5,783Per consultationVerified
Member-state competent-authority and actor-registration feesVaries by member state—By authority and procedureOfficial source
Finland flagFinland
Fimea
Annual supervision fee by number of registered devicesEUR 500–6,000$578–$6,939Per yearVerified
Sterilisation-provider annual feeEUR 1,000$1,157Per yearVerified
Importer annual feeEUR 500$578Per yearVerified
Distributor annual feeEUR 500$578Per yearVerified
First registration of a device/manufacturer in the register (2026 only)EUR 355$411Per registrationVerified
Classification decisionEUR 560$648Per decisionVerified
Determination of regulatory scope (is-it-a-device)EUR 2,240$2,591Per determinationVerified
Exemption permit (MDR Art. 59-type derogation) - MD Class I–IIa / IIb–IIIEUR 2,080–4,150$2,406–$4,800Per permitVerified
Clinical-investigation applicationEUR 790–1,970$914–$2,278Per applicationVerified
Substantial modification of a clinical investigationEUR 335$387Per modificationVerified
Notification using leftover specimens (IVDR Art. 58(2))EUR 225$260Per notificationVerified
Authority inspectionEUR 5,600$6,477Per dayVerified
Free-sale certificateEUR 170$197Per certificateVerified
France flagFrance
ANSM
Medical-device procedures (registrations, notifications, certificates)EUR 0$0Per procedureVerified
Georgia flagGeorgia
LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA)
Medical-device clinical-investigation application review fee — Class IGEL 10,000$3,839Per applicationVerified
Medical-device clinical-investigation application review fee — Classes IIa, IIb and IIIGEL 30,000$11,516Per applicationVerified
Extension of the validity of a Class I medical-device clinical-investigation certificateGEL 5,000$1,919Per extensionVerified
Extension of the validity of a Classes IIa, IIb and III medical-device clinical-investigation certificateGEL 15,000$5,758Per extensionVerified
Amendment of a medical-device clinical-investigation certificateGEL 1,000$384Per amendmentVerified
Germany flagGermany
BfArM
DiGA (digital health application) listing applicationEUR 3,000–9,900$3,470–$11,450Per applicationVerified
DiGA decision on a listing-related matter (preliminary approval etc.)EUR 1,500–6,600$1,735–$7,633Per decisionVerified
DiGA other decisionsEUR 1,500–4,900$1,735–$5,667Per decisionVerified
Ghana flagGhana
FDA Ghana
Imported product registration - Class I (low risk)USD 60$60.00Per product, per annumVerified
Imported product registration - Class II (medium risk)USD 100$100Per product, per annumVerified
Imported product registration - Class III/IV (high risk)USD 160$160Per product, per annumVerified
Locally manufactured product registrationGH¢ 250$18.75Per product, per annumVerified
Major variation - foreign productsUSD 500$500Per variationVerified
Minor variation - foreign productsUSD 300$300Per variationVerified
Major variation - local productsGH¢ 200$15.00Per variationVerified
Minor variation - local productsGH¢ 100$7.50Per variationVerified
Foreign GMP auditUSD 4,000–7,500$4,000–$7,500Per auditVerified
Local facility inspectionGH¢ 50–400$3.75–$30.00Per inspectionVerified
Storage-facility inspectionGH¢ 120–800$9.00–$60.00Per inspectionVerified
IVD laboratory analysisGH¢ 2,500$188Per analysisVerified
Equipment verificationGH¢ 2,000$150Per verificationVerified
Advertisement approvalGH¢ 600$45.00Per script, language and mediumVerified
Greece flagGreece
EOF
Register application fee (devices and IVDs)EUR 200–1,000$231–$1,157Per applicationVerified
Fee per additional packaging/sizeEUR 10$11.57Per packaging or sizeVerified
Modification of registered dataEUR 100$116Per modificationVerified
Clinical-investigation initial applicationEUR 1,000$1,157Per applicationVerified
Clinical-investigation substantial modificationEUR 500$578Per modificationVerified
Guatemala flagGuatemala
MSPAS
Inscripción Sanitaria de Producto Afín (medical devices) — arancel item IA1GTQ 100$13.10Per inscription file (expediente)Verified
Renovación de Inscripción Sanitaria de Producto Afín — arancel item IA2GTQ 100$13.10Per renewal file (expediente)Verified
Certificado de Actualización de Expediente de Inscripción Sanitaria de Producto Afín — arancel item IA3GTQ 50$6.55Per product updatedVerified
Inscripción Sanitaria de Reactivos para Diagnóstico in vitro (IVD) — arancel item IA1GTQ 100$13.10Per inscription file (expediente)Verified
Renovación de Inscripción Sanitaria de Reactivos para Diagnóstico in vitro — trámite 3358GTQ 100$13.10Per renewal file (expediente)Verified
Reconocimiento Mutuo de Producto Afín — arancel item RMA1GTQ 800$105Per recognition file (expediente)Verified
Autorizaciones Publicitarias — arancel item PU1GTQ 25$3.27Per authorisationVerified
Licencia Sanitaria de Farmacias, Droguerías y Distribuidoras — arancel item L3GTQ 170$22.27Per establishment licenceVerified
Hong Kong flagHong Kong
MDD
MDACS device-listing applicationHKD 0$0Per applicationVerified
Hungary flagHungary
NNGYK
EUDAMED actor registrationHUF 97,065$271Per registrationVerified
Custom-made-device manufacturer registrationHUF 8,100$22.60Per registrationVerified
Conformity-assessment-body designationHUF 167,000$466Per designationVerified
Certificate for aids for individual measuresHUF 189,000–508,950$527–$1,420Per certificateVerified
Notification of changesHUF 21,600$60.26Per notificationVerified
English-language certificateHUF 47,250$132Per 60 productsVerified
Deviation permitHUF 81,810$228Per permitVerified
Clinical-investigation / performance-study applicationHUF 243,000$678Per applicationVerified
Clinical investigation of devices with ionizing radiationHUF 397,845$1,110Per applicationVerified
Distributor notificationHUF 89,100$249Per notificationVerified
Notification under MDR Art. 74(1)HUF 99,000$276Per notificationVerified
Iceland flagIceland
Lyfjastofnun
Free Sales Certificate (FSC) for a medical device — five copiesISK 53,400$440Per certificateVerified
Free Sales Certificate for a medical device or an IVD — price per copy beyond the first fiveISK 26,700$220Per additional copyVerified
Other certificates — price per copyISK 40,050$330Per copyVerified
Registration of a distributor in Lyfjastofnun's distributor registerISK 53,400$440Per registrationVerified
Maintenance of a distributor registrationISK 26,700$220Per maintenance registrationVerified
Supervision of use — supervision of a medical device or an in vitro diagnostic medical deviceISK 160,200$1,320Per supervision caseVerified
Supervision of use — supervision of a management systemISK 387,150$3,191Per supervision caseVerified
Assessment of an application for exemption from the CE-marking requirements — Class IIa devices and devices that are not invasive in Class IIb and IIIISK 200,250$1,650Per applicationVerified
Assessment of an application for exemption from the requirements — Class IIb and III devices, including implantable devices, invasive devices intended for long-term use and in vitro diagnostic medical devicesISK 293,700$2,420Per applicationVerified
Other exemptionsISK 200,250$1,650Per applicationVerified
Supervision of maintenance — supervision of a medical deviceISK 200,250$1,650Per supervision caseVerified
Supervision of maintenance — supervision of a management systemISK 387,150$3,191Per supervision caseVerified
Market surveillance — distributors and importersISK 133,500$1,100Per supervision caseVerified
Quality management — distributors and importersISK 387,150$3,191Per supervision caseVerified
Market surveillance — manufacturers and authorised representativesISK 133,500$1,100Per supervision caseVerified
Quality management — manufacturers and authorised representativesISK 774,300$6,381Per supervision caseVerified
Pre-check of the content of an application for a clinical or performance investigation — Class I devices, non-invasive Class IIa and IIb devices, and IVD Class AISK 200,250$1,650Per applicationVerified
Pre-check of the content of an application for a clinical or performance investigation — Class IIa, IIb and III devices and IVD Classes B, C and DISK 200,250$1,650Per applicationVerified
Assessment of an application for a clinical investigation of a medical device — all classes of deviceISK 1,161,450$9,572Per applicationVerified
Clinical investigation of medical devices approved by LyfjastofnunISK 387,150$3,191Per approvalVerified
Amendments to a clinical investigation of medical devicesISK 106,800$880Per amendmentVerified
Lyfjastofnun hourly rate — per specialist, per hour, for supervision and services under the Medical Devices ActISK 26,700$220Per specialist-hourVerified
India flagIndia
CDSCO
Import licence - Class A manufacturing siteUSD 1,000$1,000Per siteVerified
Import licence - Class A deviceUSD 50$50.00Per distinct deviceVerified
Import licence - Class B manufacturing siteUSD 2,000$2,000Per siteVerified
Import licence - Class B deviceUSD 1,000$1,000Per distinct deviceVerified
Import licence - Class C/D manufacturing siteUSD 3,000$3,000Per siteVerified
Import licence - Class C/D deviceUSD 1,500$1,500Per distinct deviceVerified
Import licence - IVD Class A/B manufacturing siteUSD 1,000$1,000Per siteVerified
Import licence - IVD Class A/B deviceUSD 10$10.00Per distinct deviceVerified
Import licence - IVD Class C/D manufacturing siteUSD 3,000$3,000Per siteVerified
Import licence - IVD Class C/D deviceUSD 500$500Per distinct deviceVerified
Manufacture licence - Class A/B siteINR 5,000$52.34Per site; retention fee is the sameVerified
Manufacture licence - Class A/B deviceINR 500$5.23Per distinct deviceVerified
Manufacture licence - Class C/D siteINR 50,000$523Per site; retention fee is the sameVerified
Manufacture licence - Class C/D deviceINR 1,000$10.47Per distinct deviceVerified
Inspection of an overseas manufacturing siteUSD 6,000$6,000Per inspectionVerified
Permission to conduct a pilot clinical investigationINR 100,000$1,047Per permissionVerified
Permission to conduct a pivotal clinical investigationINR 100,000$1,047Per permissionVerified
Permission for clinical performance evaluationINR 25,000$262Per permissionVerified
Permission to investigate a new device with no predicateINR 50,000$523Per permissionVerified
Permission for a new in-vitro diagnostic deviceINR 25,000$262Per permissionVerified
Export certificate for a medical deviceINR 1,000$10.47Per certificateVerified
Indonesia flagIndonesia
Indonesia MoH
New registration - Class AIDR 1,500,000$84.15Per applicationVerified
New registration - Class BIDR 3,000,000$168Per applicationVerified
New registration - Class CIDR 3,000,000$168Per applicationVerified
New registration - Class DIDR 5,000,000$281Per applicationVerified
Iran flagIran
Iran FDA
Manufacturing licence - issuanceIRR 2,820,000$67.12Per licenceVerified
Manufacturing licence - renewalIRR 840,000$19.99Per renewalVerified
Iraq flagIraq
Ministry of Health
KRG device permit application formIQD 1,000$0.76Per applicationVerified
Temporary import permitIQD 20,000$15.20Per permitVerified
Ireland flagIreland
HPRA
Manufacturer establishment registration (code 431)EUR 150$173Per registrationVerified
Annual manufacturer fee by employee count (codes 458–462, 470)EUR 275–33,430$318–$38,664Per yearVerified
Annual authorised-representative fee - Type IEUR 1,200$1,388Per yearVerified
Annual authorised-representative fee - Type IIEUR 1,635$1,891Per yearVerified
Annual distributor/importer fee by employee countEUR 275–5,015$318–$5,800Per yearVerified
Clinical-investigation applicationEUR 2,075–4,700$2,400–$5,436Per applicationVerified
Clinical-investigation notification (Art. 74-type)EUR 220$254Per notificationVerified
IVD performance-study applicationEUR 2,725$3,152Per applicationVerified
Substantial modification of an investigation/studyEUR 1,360$1,573Per modificationVerified
Resubmission of an investigation/study applicationEUR 2,075$2,400Per resubmissionVerified
Free-sale certificateEUR 280$324Per certificateVerified
Registration status letterEUR 130$150Per letterVerified
Digital certificates (certified copies)EUR 200$231Per certificateVerified
Assessment of an MDR Art. 59 exemption requestEUR 4,370$5,054Per assessmentVerified
Classification determinationEUR 335–10,760$387–$12,445Per determinationVerified
Israel flagIsrael
AMAR
AMAR registration, change, or renewalILS 0$0Per applicationVerified
Italy flagItaly
AIFA
Annual contribution to the national health service (SSN) on device turnover0.75% of net-of-VAT SSN turnover contribution—Check before submissionOfficial source
Japan flagJapan
PMDA
Shonin - Class II/III (Follow-on)¥1,879,900$11,806Per approvalVerified
Shonin - Class IV (Follow-on)¥3,080,600$19,346Per approvalVerified
Shonin - Class II/III (New, no clinical)¥11,816,400$74,206Per approvalVerified
Shonin - Class IV (New, no clinical)¥16,520,700$103,748Per approvalVerified
Shonin - Class II/III (New, clinical)¥13,016,900$81,745Per approvalVerified
Shonin - Class IV (New, clinical)¥17,721,200$111,287Per approvalVerified
Government application fee for device approval - categories (1)-(2) high-risk applicationsJPY 100,000$628Per applicationVerified
Government application fee - category (5) designated devices with set review standardsJPY 33,300$209Per applicationVerified
Jordan flagJordan
JFDA
Circulation (registration) studyJOD 700$987Per studyVerified
Technical-Committee-reviewed studyJOD 100$141Per studyVerified
Import invoice approvalJOD 10$14.10Per invoiceVerified
Batch testing / circulationJOD 125$176Per batchVerified
Site approvalJOD 700$987Per approvalVerified
GLP certificate grant, renewal, or scope extensionJOD 1,000$1,410Per certificate eventVerified
Objection filingJOD 100$141Per objectionVerified
Change (variation) studyJOD 25$35.26Per changeVerified
Certificate issuanceJOD 20$28.21Per certificateVerified
Kazakhstan flagKazakhstan
Committee for Medical and Pharmaceutical Control
Registration fees expressed in monthly reference indices (MRP)11 MRP registration / 5 MRP re-registration (KZT 47,575 / 21,625 in 2026)—Check before submissionOfficial source
Kenya flagKenya
PPB
Imported device registration - Class AUSD 100$100Per productVerified
Imported device registration - Class BUSD 200$200Per productVerified
Imported device registration - Class C/DUSD 1,000$1,000Per productVerified
Locally manufactured registration - Class A/BUSD 50$50.00Per productVerified
Locally manufactured registration - Class C/DUSD 100$100Per productVerified
Variation of a registered medical device - imported productUSD 200$200Per variationVerified
Variation of a registered medical device - locally manufactured productUSD 50$50.00Per variationVerified
Annual retention - Class A/B (imported and locally manufactured)USD 50$50.00Per product, annualVerified
Annual retention - Class C/D imported product (locally manufactured USD 50)USD 300$300Per product, annualVerified
General health-product registration (L.N. 100/2022)USD 500–1,000$500–$1,000Per productVerified
Donated health-product application (L.N. 100/2022)USD 0$0Per applicationVerified
Fast-track review (L.N. 100/2022)USD 2,000$2,000Per applicationVerified
Emergency use authorisation (L.N. 100/2022)USD 2,500$2,500Per applicationVerified
Latvia flagLatvia
ZVA
Annual fee for maintaining the medical device vigilance system for class I and other (remaining) medical devices and class A in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 62.1)EUR 105.20$122Per manufacturer, authorised representative or distributor, per yearVerified
Annual fee for maintaining the medical device vigilance system for class IIa, IIb and III (including class I) medical devices and A-list, B-list and self-test, class B, class C and class D (including class A) in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 62.2)EUR 201.90$234Per manufacturer, authorised representative or distributor, per yearVerified
Issue of a medical device free-sale certificate (Cabinet Regulation No. 895, annex item 54)EUR 185.41$214Per certificateVerified
Examination of the documentation of a clinical investigation of a medical device or of a performance study of an in vitro diagnostic medical device (Cabinet Regulation No. 895, annex item 55)EUR 1,500.00$1,735Per documentation examinationVerified
Examination of the documentation of a substantial modification of a clinical investigation of a medical device or of a performance study of an in vitro diagnostic medical device (Cabinet Regulation No. 895, annex item 56)EUR 900.00$1,041Per documentation examinationVerified
Examination of the documentation for resuming a clinical investigation of a medical device or a performance study of an in vitro diagnostic medical device after the investigation was suspended (Cabinet Regulation No. 895, annex item 57)EUR 900.00$1,041Per documentation examinationVerified
Expertise on the cost-effectiveness of medical devices for one diagnosis or a group of similar diagnoses, one (single) patient group and one (single) comparable therapy (Cabinet Regulation No. 895, annex item 61)EUR 1,200.00$1,388Per documentation examinationVerified
Examination of the application and documentation to place on the market or put into service individual medical devices or in vitro diagnostic medical devices that have not undergone the conformity assessment procedures laid down in the regulatory enactments and are not marked with the CE marking (Cabinet Regulation No. 895, annex item 63)EUR 528.60$611Per documentation examinationVerified
Consultation on questions concerning the classification, clinical evaluation and performance evaluation of medical devices and in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 8.1)EUR 2,000.00$2,313Per consultationVerified
State fee for the issue of a registration certificate for activities with ionizing radiation sources (Cabinet Regulation No. 65, § 63.1)EUR 97.00$112Per registration certificateVerified
State fee for the issue of a licence for activities with ionizing radiation sources (Cabinet Regulation No. 65, § 63.2)EUR 170.00$197Per licenceVerified
Lebanon flagLebanon
Ministry of Public Health
Fiscal stamp on the device entry or import approval (form MPH12-26)LBP 1,000$0.01Per applicationVerified
Fiscal stamp on the sterile medical instruments import application (form MPH212-9)LBP 1,000$0.01Per applicationVerified
Fiscal stamp on the medical or laboratory reagents import application (form MPH212-3)LBP 1,000$0.01Per applicationVerified
Liechtenstein flagLiechtenstein
Office of Public Health
Processing of a notification for placing a device on the marketCHF 300$369Per notificationVerified
Exceptional authorisation for a non-compliant deviceCHF 1,000$1,230Per authorisationVerified
Authorisation of a new clinical investigationCHF 5,000$6,150Per investigationVerified
Notified-body first designation or renewalCHF 15,000$18,451Per designationVerified
Free-sale certificateCHF 200$246Per certificateVerified
Lithuania flagLithuania
VASPVT
Registration of a device placed on the Lithuanian marketEUR 38$43.95Per deviceVerified
Registration of changed data about a device already placed on the marketEUR 18$20.82Per changeVerified
Certificate authorising a person to perform device technical-condition inspectionsEUR 145$168Per certificateVerified
Free-sale certificate for medical devicesEUR 32$37.01Per certificateVerified
Authorisation of a clinical investigation with a device or of a performance studyEUR 1,407$1,627Per authorisationVerified
Authorisation of substantial modifications to a clinical investigation or performance studyEUR 998$1,154Per modificationVerified
Assessment of a body applying to be designated a medical-device notified bodyEUR 3,502$4,050Per assessmentVerified
Assessment of a notified body applying to extend its scopeEUR 1,737$2,009Per assessmentVerified
Macau flagMacau
ISAF
Class IIb/III registration - statutory base feeMOP 500$61.86Per applicationVerified
Class IIb/III first application including stamp dutyMOP 550$68.04First application; full amount due at submissionVerified
Class IIb/III registration renewal including stamp dutyMOP 220$27.22Per renewalVerified
Class I/IIa filing application (備案)MOP 0$0Per filingVerified
Malaysia flagMalaysia
MDA
Registration application fee - Class AMYR 500$122Per applicationVerified
Registration application fee - Class BMYR 250$61.18Per applicationVerified
Registration application fee - Class CMYR 500$122Per applicationVerified
Registration application fee - Class DMYR 750$184Per applicationVerified
Registration fee (on registration) - Class AMYR 750$184Per registration, 5-year validityVerified
Registration fee - Class BMYR 1,000$245Per registration, 5-year validityVerified
Registration fee - Class CMYR 2,000$489Per registration, 5-year validityVerified
Registration fee - Class DMYR 3,000$734Per registration, 5-year validityVerified
Registration fee - device incorporating a medicinal productMYR 5,000$1,224Per registration, 5-year validityVerified
Establishment-licence application fee (per role: manufacturer, AR, distributor, importer)MYR 250$61.18Per roleVerified
Establishment licence - manufacturerMYR 4,000$979Per licenceVerified
Establishment licence - authorised representativeMYR 4,000$979Per licenceVerified
Establishment licence - distributorMYR 2,000$489Per licenceVerified
Establishment licence - importerMYR 2,000$489Per licenceVerified
Establishment-licence renewal application feeMYR 200$48.95Per roleVerified
Establishment-licence renewal - manufacturer or authorised representativeMYR 2,000$489Per renewalVerified
Establishment-licence renewal - distributor or importerMYR 1,000$245Per renewalVerified
Conformity-assessment-body registration applicationMYR 1,500$367Per applicationVerified
Conformity-assessment-body registrationMYR 8,000$1,958Per registrationVerified
Export permitMYR 100$24.47Per permitVerified
AppealMYR 250$61.18Per appealVerified
Advertising-approval processing feeMYR 1,000$245Per advertisementVerified
Malta flagMalta
Medicines Authority
Initial application for organisation registration of distributor/importerEUR 500$578Per applicationVerified
Certificate of Free Sale applicationEUR 250$289Per declaration of conformityVerified
Device Registration — placing a medical device on the European market applicationEUR 100$116Per declaration of conformityVerified
Derogation application in terms of Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746EUR 1,000$1,157Per applicationVerified
Derogation application in terms of Article 97 of Regulation (EU) 2017/745 and Article 92 of Regulation (EU) 2017/746EUR 1,000$1,157Per applicationVerified
MDR and IVDR derogation renewalEUR 750$867Per renewalVerified
Request form for medical device / in vitro diagnostic confirmation of risk classificationEUR 1,000$1,157Per requestVerified
Pre-submission meeting request applicationEUR 1,000$1,157Per requestVerified
Application/notification for clinical investigation in accordance with Articles 62 and 74(1) of Regulation (EU) 2017/745EUR 5,000$5,783Per applicationVerified
Application/notification for clinical investigation in accordance with Article 82 of Regulation (EU) 2017/745EUR 1,000$1,157Per applicationVerified
Application/notification for performance study in accordance with Regulation (EU) 2017/746EUR 5,000$5,783Per applicationVerified
Application for use of a non-CE marked medical device in MaltaEUR 500$578Per applicationVerified
Inspection letter for distributor/importerEUR 300$347Every 3 yearsVerified
Notified Body Designation application — initial setup of notified bodyEUR 30,000$34,697Per applicationVerified
Mexico flagMexico
COFEPRIS
Initial registration - Class I (LFD Art. 195-A III)MXN 16,498.70$969Per deviceVerified
Initial registration - Class II (LFD Art. 195-A III)MXN 24,198.08$1,422Per deviceVerified
Initial registration - Class III (LFD Art. 195-A III)MXN 30,797.57$1,810Per deviceVerified
Second and subsequent renewal - Class I (75%)MXN 12,374.03$727Per renewalVerified
Second and subsequent renewal - Class II (75%)MXN 18,148.56$1,066Per renewalVerified
Second and subsequent renewal - Class III (75%)MXN 23,098.18$1,357Per renewalVerified
Import permit - raw material or finished product (LFD Art. 195-G III)MXN 3,116.65$183Per applicationVerified
Import permit - donationMXN 440.45$25.88Per applicationVerified
Import-permit modification, correction, or extensionMXN 440.45$25.88Per applicationVerified
Clinical-research protocol authorization (LFD Art. 195-I VI)MXN 8,195.58$482Per protocol applicationVerified
Free-sale certificate for export of insumos (LFD Art. 195-E I)MXN 2,965.09$174Per certificateVerified
GMP certificate for insumos para la salud (LFD Art. 195-E X)MXN 2,783.80$164Per certificateVerified
Cession-of-rights inscription - individuals (LFD Art. 195-K)MXN 201.40$11.83Per inscriptionVerified
Cession-of-rights inscription - legal entitiesMXN 1,009.88$59.34Per inscriptionVerified
Moldova flagMoldova
AMDM
Registration and re-registration of medical devicesMDL 1,794$103Per application (1 cerere)Verified
Evaluation of a dossier for the authorisation of clinical investigations with medical devicesMDL 26,054$1,500Per dossier (1 dosar)Verified
Approval of type I changes to medical devicesMDL 897$51.63Per application (1 cerere)Verified
Approval of type II changes to medical devicesMDL 1,211$69.70Per application (1 cerere)Verified
Mongolia flagMongolia
Ministry of Health / Medical Device and Medical Equipment Regulatory Agency (MMRA); State Stamp Duty administered under the Law on State Stamp Duty
Special permit to manufacture and export medicines, medical equipment, laboratory diagnostic devices and medical suppliesMNT 44,000–110,000$12.24–$30.61Per permit issuedVerified
Special permit to import and supply medicines, medical equipment, laboratory diagnostic devices and medical suppliesMNT 50,000–200,000$13.91–$55.65Per permit issuedVerified
Special permit to sell medicines and medical devicesMNT 44,000–110,000$12.24–$30.61Per permit issuedVerified
State stamp duty — combined manufacture, sale and import permit for medicines, medical devices, instruments, equipment, prostheses and orthopaedicsMNT 110,000$30.61Per permit issuedVerified
Montenegro flagMontenegro
CInMED
Registration of Class I medical devices — up to 25 products in the applicationEUR 100$116Per application, tiered by the number of productsVerified
Registration of Class I medical devices — over 100 products in the applicationEUR 60$69.39Per application, tiered by the number of productsVerified
Registration of Class IIa medical devices — up to 25 products in the applicationEUR 200$231Per application, tiered by the number of productsVerified
Registration of Class IIb medical devices — up to 25 products in the applicationEUR 300$347Per application, tiered by the number of productsVerified
Registration of Class III medical devices — up to 15 products in the applicationEUR 400$463Per application, tiered by the number of productsVerified
Registration of in vitro diagnostic medical devices — up to 25 products in the applicationEUR 100$116Per application, tiered by the number of productsVerified
Registration of active implantable devices and of apparatus belonging to classes I, IIa, IIb and III, and in vitro apparatus — up to 10 productsEUR 450$520Per application, tiered by the number of productsVerified
Authorisation to import unregistered medical devices, under čl. 66 of the Law — up to 5 devicesEUR 60$69.39Per authorisation, tiered by the number of devicesVerified
Annual vigilance-system maintenance per decision — Class III medical devicesEUR 40$46.26Per decision, annuallyVerified
Decision on the classification of a medical deviceEUR 300$347Per requestVerified
Registration of a Class III medical device without a conformity document issued by an EU manufacturer or an EU-notified conformity-assessment bodyEUR 600$694Per applicationVerified
Morocco flagMorocco
Agence Marocaine des Médicaments et des Produits de Santé (AMMPS)
Certificat d'enregistrement d'un dispositif médical1 000 MAD (TTC)$105Per registration certificateVerified
Certificat d'enregistrement d'un réactif à usage diagnostic in vitro500 MAD (TTC)$52.75Per registration certificateVerified
Frais d'études d'agrément d'un équipement (ANRT)500 MAD (HT)$52.75Per equipment itemVerified
Netherlands flagNetherlands
Farmatec (CIBG)
National device-notification feeEUR 200$231Per notificationVerified
Free-sale / export certificateEUR 62$71.71Per certificateVerified
New Zealand flagNew Zealand
Medsafe
WAND database notification (all device classes)NZD 0$0Per notificationVerified
Nigeria flagNigeria
NAFDAC
Registration - Medical Devices 1 and 2, local (per product)NGN 20,000$13.00Per productVerified
Registration - Medical Devices 1 (all except diapers/sanitary pads), foreignUSD 750$750Per productVerified
Registration - Medical Devices 2 (diapers and sanitary pads), foreignUSD 874$874Per productVerified
Laboratory analysis - other medical devices, localNGN 29,700$19.31Per sampleVerified
Laboratory analysis - other medical devices, foreignNGN 67,500$43.88Per sampleVerified
Port inspection of imported products - medical devicesNGN 27,000$17.55Per 20ft containerVerified
Permit for service drugs (incl. orphan drugs)/medical devicesNGN 11,000$7.15Per productVerified
Advertisement - single productNGN 15,000$9.75Per advertisementVerified
Change in brand name at company instanceNGN 27,500 (USD 206.25 foreign)$17.88Per changeVerified
Change of package label/design/pack-size extensionNGN 21,000 (USD 206.25 foreign)$13.65Per changeVerified
North Macedonia flagNorth Macedonia
Агенција за лекови и медицински средства (MALMED)
Register entry — medical device of class IEUR 300$347Per deviceVerified
Register entry — medical device of class II-аEUR 400$463Per deviceVerified
Register entry — medical device of class II-бEUR 400$463Per deviceVerified
Register entry — medical device of class IIIEUR 500$578Per deviceVerified
Register entry — in vitro diagnostic device on List АEUR 300$347Per deviceVerified
Register entry — in vitro diagnostic device on List БEUR 300$347Per deviceVerified
Register entry — in vitro diagnostic device for self-diagnosisEUR 200$231Per deviceVerified
Register entry — all other in vitro diagnostic devicesEUR 400$463Per deviceVerified
Minor variation notified to the register of medical devicesEUR 10$11.57Per variationVerified
Parallel-import approval — medical device, up to 25 products of the same class, list or product group from one manufacturerEUR 40$46.26Per productVerified
Parallel-import approval — medical device, up to 100 productsEUR 24$27.76Per productVerified
Parallel-import approval — medical device, over 100 productsEUR 8$9.25Per productVerified
Entry in the register of legal persons for wholesale trade in medical devicesEUR 471$545Per applicationVerified
Entry in the register of specialised shops for retail trade in certain kinds of medical deviceEUR 160$185Per applicationVerified
Authorisation to manufacture a medical device of a given type and model at a given place of manufactureEUR 1,000$1,157Per type, model and place of manufactureVerified
Approval or notification for a clinical investigation of a medical deviceEUR 240$278Per applicationVerified
Opinion of the Ethics Committee for a clinical investigation of a medical deviceEUR 240$278Per applicationVerified
Assessment of documentation for a certificate classifying a product as a medicine or a medical deviceEUR 45$52.05Per applicationVerified
Norway flagNorway
Norwegian Medical Products Agency
Processing of clinical-investigation applications and notificationsNOK 0$0Per applicationVerified
Oman flagOman
Ministry of Health
Device registration - Class A/BOMR 100$260Per registrationVerified
Device registration - Class C/DOMR 200$520Per registrationVerified
Manufacturer registration - non-local manufacturerOMR 500$1,300Per registration (5 years)Verified
Manufacturer registration - local manufacturerOMR 1,500$3,901Per registration (3 years)Verified
Medical device variationOMR 25$65.02Per variationVerified
Release/customs clearance of medical devices and suppliesOMR 5$13.00Per consignmentVerified
Pakistan flagPakistan
DRAP
Class A enlistment - local manufacture or importPKR 6,300$22.68Per device; same row covers renewalVerified
Enlistment or registration - accessory or component, local manufacturePKR 6,300$22.68Per device; same row covers renewalVerified
Class B registration - imported device, accessory, or componentPKR 32,400$117Per registrationVerified
Class B registration renewal - imported devicePKR 15,700$56.53Per renewalVerified
Class C/D registration - imported device, accessory, or componentPKR 64,800$233Per registrationVerified
Class C/D registration renewal - imported devicePKR 32,400$117Per renewalVerified
Class B/C/D registration - local manufacturePKR 26,100$93.97Per registrationVerified
Class B/C/D registration renewal - local manufacturePKR 12,500$45.01Per renewalVerified
Establishment licence to manufacture medical devicesPKR 128,500$463Per licenceVerified
Establishment licence renewal - manufacturePKR 64,800$233Per renewalVerified
Establishment licence to import medical devicesPKR 26,100$93.97Per licenceVerified
Establishment licence renewal - importPKR 12,500$45.01Per renewalVerified
Application for appeal before the Appellate BoardPKR 64,800$233Per appealVerified
Miscellaneous application having commercial significancePKR 9,400$33.84Per applicationVerified
Certificate to outsource manufacturing processes or analysisPKR 64,800$233Per contract acceptorVerified
Outsourcing-certificate renewalPKR 32,400$117Per renewalVerified
Panama flagPanama
DNDM (MINSA)
Licencia de Operación - FabricanteB/. 350$350Per licenceVerified
Licencia de Operación - AcondicionadorB/. 225$225Per licenceVerified
Licencia de Operación - DistribuidorB/. 200$200Per licenceVerified
Licencia de Operación - MinoristaB/. 150$150Per licenceVerified
Licencia de Operación - AlmacénB/. 150$150Per licenceVerified
Actualización de la Licencia de OperaciónB/. 25$25.00Per updateVerified
Paraguay flagParaguay
DINAVISA
Registro de Familia de Dispositivos médicos, materiales cortopunzantes y equipos de protección individual — Clase I NacionalPYG 1.170.770$196Per family registrationVerified
Registro de Familia de Dispositivos médicos — Clase I ImportadoPYG 1.756.155$294Per family registrationVerified
Registro de Familia de Dispositivos médicos — Clase II NacionalPYG 1.756.155$294Per family registrationVerified
Registro de Familia de Dispositivos médicos — Clase II ImportadoPYG 2.341.540$392Per family registrationVerified
Registro de Familia de Dispositivos médicos — Clase III NacionalPYG 2.341.540$392Per family registrationVerified
Registro de Familia de Dispositivos médicos — Clase III ImportadoPYG 2.926.925$490Per family registrationVerified
Registro de Familia de Dispositivos médicos — Clase IV NacionalPYG 2.926.925$490Per family registrationVerified
Registro de Familia de Dispositivos médicos — Clase IV ImportadoPYG 3.512.310$588Per family registrationVerified
Renovación de Registro de Familia de Dispositivos médicos — Clase IV ImportadoPYG 3.278.156$549Per renewal, every 10 yearsVerified
Modificación de Registro de Familia de Dispositivos médicos, materiales cortopunzantes y equipos de protección individualPYG 585.385$98.03Per modificationVerified
Registros Sanitarios Nuevos/Renovación de Producto para diagnósticos de uso in vitro, de origen nacionalPYG 2.107.386$353Per product, new registration or renewalVerified
Registros Sanitarios Nuevos/Renovación de Producto para diagnósticos de uso in vitro, de origen importadoPYG 2.341.540$392Per product, new registration or renewalVerified
Autorización para importación de Dispositivos Médicos — para empresas registradasPYG 234.154$39.21Per import authorisationVerified
Inspección para aperturas, traslado de representantes, importadoras, exportadoras, distribuidoras, depósitos, comercializadoras, fraccionadoras, envasadoras y laboratorios de producción de dispositivos médicosPYG 4.097.695$686Per inspectionVerified
Peru flagPeru
DIGEMID / VUCE
Registration (inscripción) - Class I medical devicePEN 1,438.70$427Per application (procedure PA990006DD)Verified
Re-registration (reinscripción) - Class I medical devicePEN 1,405.40$417Per application (procedure PA9900DDA7)Verified
Registration - Class II medical devicePEN 1,593.20$473Per application (procedure PA99008E39)Verified
Re-registration - Class II medical devicePEN 1,562.90$464Per application (procedure PA990012F8)Verified
Registration - Class III medical device (high risk)PEN 1,948.40$578Per application (procedure PA990049F8)Verified
Re-registration - Class III medical devicePEN 1,806.90$536Per application (procedure PA9900B054)Verified
Registration - Class IV medical device (critical risk)PEN 2,176.40$646Per application (procedure PA99006495)Verified
Re-registration - Class IV medical devicePEN 2,138.40$635Per application (procedure PA990011832)Verified
Registration - in-vitro diagnostic devicePEN 1,965.10$583Per application (procedure PA990002F5)Verified
Re-registration - in-vitro diagnostic devicePEN 1,915.10$568Per application (procedure PA990033E4)Verified
Change to the sanitary registration - significant repercussion on quality, safety, or efficacyPEN 646.70$192Per application (procedure PA9900E4FF)Verified
Philippines flagPhilippines
FDA Philippines
Initial Certificate of Medical Device Notification - Class APHP 7,575$123Per productVerified
Initial Certificate of Medical Device Registration - Class BPHP 7,575$123Per productVerified
Initial Certificate of Medical Device Registration - Class C/DPHP 7,575$123Per productVerified
Initial notification - Class B/C/D not yet included in the registrable-device listPHP 3,030$49.28Per productVerified
CMDN/CMDR renewal - Class A/B/C/DPHP 5,050$82.13Per product renewalVerified
Variation of CMDR / CPR-IVD - applicationPHP 510$8.29Per applicationVerified
Variation - change in brand namePHP 2,525$41.06Per applicationVerified
Variation - shelf-life extensionPHP 1,010$16.43Per applicationVerified
Compassionate Special Permit - devicePHP 510$8.29Per applicationVerified
CPR for IVD initial application - 1-year validityPHP 1,515$24.64Per productVerified
CPR for IVD initial application - hCG products, 6-year validityPHP 2,525$41.06Per productVerified
Licence to Operate - medical-device retailer, initialPHP 2,000$32.53Per licence, valid 2 yearsVerified
Licence to Operate - medical-device retailer, renewalPHP 3,000$48.79Per renewal, valid 3 yearsVerified
Licence to Operate - variationPHP 500$8.13Per variationVerified
Poland flagPoland
URPL
Free-sale certificate application (Act Art. 30(1))PLN 700$184Per applicationVerified
Clinical-investigation application (MDR Art. 70(1))PLN 6,000$1,578Per applicationVerified
Substantial modification notification (MDR Art. 75(1))PLN 2,000$526Per notificationVerified
Post-market clinical follow-up investigation application (Act Art. 33(3))PLN 6,000$1,578Per applicationVerified
Performance-study application (IVDR Art. 66(1))PLN 6,000$1,578Per applicationVerified
Substantial modification notification (IVDR Art. 71(1))PLN 2,000$526Per notificationVerified
Consultations and opinions (Act Art. 52: advertising opinions, borderline determinations, derogation permits)PLN 80,000$21,040Per requestVerified
Portugal flagPortugal
INFARMED
Clinical-study application - non-CE device or CE outside intended purposeEUR 1,000$1,157Per applicationVerified
Clinical-study application - CE-marked deviceEUR 600$694Per applicationVerified
Study notification - non-CE deviceEUR 600$694Per notificationVerified
Study notification - CE-marked deviceEUR 400$463Per notificationVerified
Study protocol amendmentEUR 200$231Per amendmentVerified
Romania flagRomania
ANMDMR
Customs aviz (import authorisation)RON 120$27.96Per productVerified
Free-sale certificateRON 1,240$289Per certificate (1–10 articles)Verified
National database registration certificateRON 1,310$305Per certificate (max 5 products)Verified
In-house device notification dossierRON 1,310$305Per productVerified
Database modificationRON 350$81.55Per modification (max 5 products)Verified
Database searchRON 220$51.26Per searchVerified
EUDAMED registration validationRON 220$51.26Per validationVerified
Clinical-investigation authorisation - Class III / IIb invasive / implantable / Annex XVIRON 20,450$4,765Per authorisationVerified
Clinical-investigation validation - Class IIa–IIb non-invasiveRON 18,030$4,201Per validationVerified
Clinical-investigation validation - Class I–IIa non-invasiveRON 8,770$2,043Per validationVerified
CI/performance-study substantial or technical amendmentRON 5,930$1,382Per amendmentVerified
IVD performance-study authorisation - self-test and Class C/DRON 13,710$3,194Per authorisationVerified
PMCF/PMPF notification evaluationRON 1,880$438Per notificationVerified
Advertising material avizareRON 2,720$634Per materialVerified
Import/distribution operating avizRON 1,480–2,620$345–$610Per avizVerified
Installation/maintenance operating avizRON 1,660–2,320$387–$541Per avizVerified
Notified-body designationRON 40,800$9,506Per designationVerified
Russia flagRussia
Roszdravnadzor
Registration certificate state dutyRUB 11,000$132Per registrationVerified
Expertise - Class 1RUB 72,000$863Per registrationVerified
Expertise - Class 2aRUB 104,000$1,246Per registrationVerified
Expertise - Class 2bRUB 136,000$1,630Per registrationVerified
Expertise - Class 3RUB 184,000$2,205Per registrationVerified
Expertise - Class 1 device on the deficit list (Decree No. 552/2022)RUB 32,000$383Per registrationVerified
Rwanda flagRwanda
Rwanda FDA
Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from the EACUSD 100$100Per product, five-year registrationVerified
Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from SRAs or WHO Listed AuthoritiesUSD 400$400Per product, five-year registrationVerified
Registration and marketing authorisation of imported machinery, medical equipment and devices - to be imported from other sourcesUSD 600$600Per product, five-year registrationVerified
Notification of the registration of machinery, medical equipment and devicesUSD 0$0Per notificationVerified
Saudi Arabia flagSaudi Arabia
SFDA
Application Assessment - Class ASAR 15,000$4,000Per applicationVerified
Application Assessment - Class BSAR 19,000$5,067Per applicationVerified
Application Assessment - Class CSAR 21,000$5,600Per applicationVerified
Application Assessment - Class DSAR 23,000$6,133Per applicationVerified
Establishment licence - medical-device manufacturerSAR 5,000$1,333Per 5-year licenceVerified
Establishment licence - authorised representativeSAR 2,600$693Per year (1–10 years, per contract)Verified
Establishment licence - distributor/importer Class ASAR 25,000$6,667Per yearVerified
Establishment licence - distributor/importer Class BSAR 15,000$4,000Per yearVerified
Establishment licence - distributor/importer Class CSAR 8,000$2,133Per yearVerified
Establishment licence - distributor/importer Class DSAR 5,000$1,333Per yearVerified
Establishment licence - warehouseSAR 800$213Per year (1–5 years; SAR 800 each additional year)Verified
Advertising approval - directed to lay personsSAR 3,000$800Per approvalVerified
Advertising approval - directed to health practitionersSAR 6,000$1,600Per approvalVerified
Senegal flagSenegal
Agence sénégalaise de Réglementation pharmaceutique (ARP)
Marketing authorisation — Class D device, registration (enregistrement)XOF 1,000,000$1,759Per productVerified
Marketing authorisation — Class D device, renewal (renouvellement)XOF 500,000$879Per product, every 5 yearsVerified
Marketing authorisation — Class D device, major variationXOF 1,000,000$1,759Per variationVerified
Marketing authorisation — Class D device, minor variationXOF 250,000$440Per variationVerified
Marketing authorisation — Class C device, registration (enregistrement)XOF 500,000$879Per productVerified
Marketing authorisation — Class C device, renewal (renouvellement)XOF 250,000$440Per product, every 5 yearsVerified
Marketing authorisation — Class C device, major variationXOF 500,000$879Per variationVerified
Marketing authorisation — Class C device, minor variationXOF 250,000$440Per variationVerified
Class A and class B devices — declaration (déclaration de dispositifs médicaux)XOF 10,000$17.59Per productVerified
Locally manufactured device — registration (cas des industries locales)XOF 500,000$879Per productVerified
Locally manufactured device — renewal (cas des industries locales)XOF 500,000$879Per product, every 5 yearsVerified
Locally manufactured device — major variation (cas des industries locales)XOF 250,000$440Per variationVerified
Locally manufactured device — minor variation (cas des industries locales)XOF 125,000$220Per variationVerified
Serbia flagSerbia
ALIMS
Registration - Class I, up to 25 productsRSD 13,450$133Per deviceVerified
Registration - Class I, 26–100 productsRSD 10,800$106Per deviceVerified
Registration - Class I, over 100 productsRSD 8,100$79.87Per deviceVerified
Registration - Class IIa, up to 25 productsRSD 33,600$331Per deviceVerified
Registration - Class IIa, 26–100 productsRSD 26,900$265Per deviceVerified
Registration - Class IIa, over 100 productsRSD 20,200$199Per deviceVerified
Registration - Class IIb, up to 25 productsRSD 40,400$398Per deviceVerified
Registration - Class IIb, over 25 productsRSD 32,300$318Per deviceVerified
Registration - Class III, up to 15 productsRSD 67,300$664Per deviceVerified
Registration - Class III, over 15 productsRSD 53,800$530Per deviceVerified
Annual vigilance fee per registered deviceRSD 1,180–5,900$11.64–$58.18Annual, by 30 AprilVerified
Free Sale CertificateRSD 14,200$140Per certificateVerified
Commercial clinical-trial approvalRSD 371,700$3,665Per approvalVerified
Singapore flagSingapore
HSA
Class A Product RegistrationSGD 0$0Not applicableVerified
Application Fee - Class B/C/DSGD 560$438Per applicationVerified
Evaluation - Immediate (Class B)SGD 1,000$782Per applicationVerified
Evaluation - Abridged (Class B)SGD 2,010$1,572Per applicationVerified
Evaluation - Full (Class B)SGD 3,900$3,049Per applicationVerified
Evaluation - Priority Full Route 1 (Class B)SGD 4,420$3,456Per applicationVerified
Evaluation - Priority Full Route 2 (Class B)SGD 5,660$4,425Per applicationVerified
Evaluation - Immediate/Expedited (Class C)SGD 3,340$2,611Per applicationVerified
Evaluation - Abridged (Class C)SGD 3,900$3,049Per applicationVerified
Evaluation - Full (Class C)SGD 6,250$4,887Per applicationVerified
Evaluation - Priority Full Route 1 (Class C)SGD 7,000$5,473Per applicationVerified
Evaluation - Priority Full Route 2 (Class C)SGD 9,000$7,037Per applicationVerified
Evaluation - Expedited (Class D)SGD 5,930$4,637Per applicationVerified
Evaluation - Abridged (Class D)SGD 6,250$4,887Per applicationVerified
Evaluation - Full (Class D)SGD 12,000$9,383Per applicationVerified
Evaluation - Priority Full Route 1 (Class D)SGD 13,600$10,634Per applicationVerified
Evaluation - Priority Full Route 2 (Class D)SGD 17,500$13,683Per applicationVerified
Evaluation - Abridged (Class D with Registrable Drug)SGD 10,600$8,288Per applicationVerified
Evaluation - Full (Class D with Registrable Drug)SGD 75,600$59,110Per applicationVerified
Annual Retention - Class BSGD 39$30.49AnnualVerified
Annual Retention - Class CSGD 67$52.39AnnualVerified
Annual Retention - Class DSGD 134$105AnnualVerified
Change of RegistrantSGD 880$688Per applicationVerified
Change notification application - Class BSGD 560$438Per applicationVerified
Change notification - Class C administrativeSGD 560$438Per applicationVerified
Change notification - Class C technicalSGD 1,890$1,478Per applicationVerified
Change notification - Class D administrativeSGD 560$438Per applicationVerified
Change notification - Class D technicalSGD 3,120$2,439Per applicationVerified
Importer, wholesaler, or manufacturer licenceSGD 1,110$868New or annual renewalVerified
Dealer licence amendmentSGD 168$131Per amendmentVerified
Free Sale / Export Certificate applicationSGD 57$44.57Per applicationVerified
Free Sale / Export Certificate processingSGD 57$44.57Per device and countryVerified
Medical-device development consultationSGD 530$414Per device, up to 2 hoursVerified
Medical-device pre-submission consultationSGD 210$164Per application, up to 1 hourVerified
Special Access Route - re-export or non-clinical useSGD 280$219Per applicationVerified
Special Access Route - qualified practitionerSGD 168$131Per applicationVerified
Special Access Route - licensed healthcare facilitySGD 390$305Per applicationVerified
Slovakia flagSlovakia
ŠÚKL
Distributor registration decision (item 96.1.56)EUR 500$578Per registrationVerified
Clinical-investigation authorisation proceedings (item 96.1.57)EUR 500$578Per applicationVerified
Notification of substantial change to a clinical investigation (item 96.1.58)EUR 500$578Per notificationVerified
Notification of a clinical investigation of a CE-marked device (item 96.1.59)EUR 500$578Per notificationVerified
Free-sale certificate for devices and IVDs (item 152 aj)EUR 300$347Per certificateVerified
Registration of an SR-seated manufacturer/EC representativeEUR 750$867Per registrationVerified
Technical-documentation assessment of each additional device under the same registrationEUR 430$497Per additional deviceVerified
Slovenia flagSlovenia
JAZMP
Notified-body annual feeEUR 50,000$57,829Per yearVerified
Notified-body evaluation and (re)designationEUR 70,000$80,961Per procedureVerified
Notified-body scope extensionEUR 1,000$1,157Per codeVerified
Manufacturer annual fee by net revenue and risk classEUR 800–14,000$925–$16,192Per yearVerified
Authorised-representative annual fee by net revenueEUR 2,000–8,000$2,313–$9,253Per yearVerified
Custom-made-device manufacturer annual feeEUR 800$925Per yearVerified
Distributor annual fee by net revenueEUR 350–4,500$405–$5,205Per yearVerified
Importer annual fee by net revenueEUR 800–5,000$925–$5,783Per yearVerified
Combined importer+distributor annual fee by net revenueEUR 1,100–7,000$1,272–$8,096Per yearVerified
Single-use-device reprocessor annual feeEUR 3,500$4,048Per yearVerified
Health-institution in-house production annual feeEUR 2,500$2,891Per yearVerified
Free-sale certificateEUR 150$173Per certificateVerified
Clinical-investigation applicationEUR 2,000–4,175$2,313–$4,829Per applicationVerified
IVD performance-study applicationEUR 2,000–4,175$2,313–$4,829Per applicationVerified
Decision in a manufacturer/notified-body disputeEUR 5,000$5,783Per decisionVerified
Exceptional-approval handlingEUR 150$173Per hourVerified
South Africa flagSouth Africa
SAHPRA
New medical-device/IVD establishment licence - manufacturerZAR 26,200$1,618Per establishment licenceVerified
New medical-device/IVD establishment licence - distributor or wholesalerZAR 15,600$964Per establishment licenceVerified
Establishment-licence renewal - manufacturerZAR 22,900$1,415Per renewalVerified
Establishment-licence renewal - distributorZAR 13,160$813Per renewalVerified
Establishment-licence renewal - wholesalerZAR 13,100$809Per renewalVerified
Annual establishment-licence retentionZAR 4,400$272Annual, by the last working day of JuneVerified
Establishment-licence amendmentZAR 5,500$340Per amendmentVerified
Approved licence issuance / collectionZAR 3,500$216Per licenceVerified
Certificate of Free SaleZAR 1,460$90.19Per certificateVerified
Clinical-trial application - safety and efficacy, including devices/IVDsZAR 33,700$2,082Per applicationVerified
Inspection charge-out rateZAR 1,660$103Per hour, per inspectorVerified
South Korea flagSouth Korea
MFDS
Product application without technical reviewKRW 158,000–176,000$112–$124Per applicationVerified
Product application with technical documentsKRW 719,000–799,000$508–$564Per applicationVerified
Product application with clinical dataKRW 1,495,000–1,662,000$1,056–$1,174Per applicationVerified
Separate technical-document evaluationKRW 561,000–624,000$396–$441When applicableVerified
Separate technical-document and clinical-data evaluationKRW 1,338,000–1,488,000$945–$1,051When applicableVerified
Manufacturing/import business licence applicationKRW 144,000–160,000$102–$113Per applicationVerified
Innovative medical device (신개발의료기기) approval including technical-document reviewKRW 98,430,000$69,541Per approvalVerified
Approval renewalKRW 500,000–520,000$353–$367Per renewalVerified
Certification applicationKRW 130,000–145,000$91.85–$102Per applicationVerified
Certification renewalKRW 430,000–450,000$304–$318Per renewalVerified
NotificationKRW 85,000–96,000$60.05–$67.82Per notificationVerified
Notification renewalKRW 100,000$70.65Per renewalVerified
Change approval - documents and clinical reviewKRW 1,009,000–1,122,000$713–$793Per applicationVerified
Change approval - document reviewKRW 551,000–612,000$389–$432Per applicationVerified
Change certificationKRW 80,000–98,000$56.52–$69.24Per applicationVerified
Change notificationKRW 38,000–48,000$26.85–$33.91Per notificationVerified
Post-market survey result reviewKRW 90,000–100,000$63.59–$70.65Per reviewVerified
Sales/rental business notificationKRW 8,000–10,000$5.65–$7.06Per notificationVerified
English certificateKRW 21,000–24,000$14.84–$16.96Per certificateVerified
Permit/certificate reissueKRW 2,200–3,400$1.55–$2.40Per reissueVerified
Technical-document pre-reviewKRW 524,000–583,000$370–$412Per reviewVerified
Spain flagSpain
AEMPS
Registration/communication of medical devices (code 5.01)EUR 99.71$115Per communicationVerified
Prior operating licence - manufacturing, sterilisation, reprocessing establishments (code 5.17)EUR 983.85$1,138Per licenceVerified
Manufacturing-licence modification/revalidation (code 5.19)EUR 983.85$1,138Per modificationVerified
Prior operating licence - import and grouping establishments (code 5.18)EUR 491.92$569Per licenceVerified
Import-licence modification/revalidation (code 5.20)EUR 491.92$569Per modificationVerified
Minor modification of licences (code 5.21)EUR 245.96$284Per modificationVerified
Authorisation of clinical investigations / IVD evaluation studies (code 5.22)EUR 1,553.51$1,797Per applicationVerified
Substantial modification of a clinical investigation (code 5.23)EUR 543.73$629Per modificationVerified
Classification/qualification analysis consultation (code 5.26)EUR 211.61$245Per consultationVerified
Authorisation of import of human-origin raw materials for IVD manufacture (code 5.24)EUR 87.40$101Per authorisationVerified
Sri Lanka flagSri Lanka
NMRA
New application processing fee - foreign applicantUSD 1,000$1,000Per applicationVerified
New application processing fee - local applicantUSD 250–750$250–$750Per applicationVerified
Registration renewal after five yearsUSD 200–750$200–$750Every 5 yearsVerified
Certificate of registration valid for five yearsUSD 100–400$100–$400Per certificateVerified
Provisional registration certificate (maximum two years)USD 50–200$50.00–$200Per certificateVerified
Additional data evaluationUSD 100–500$100–$500Per evaluationVerified
Variation that requires reviewUSD 200$200Per variationVerified
Foreign manufacturing plant approval processing feeUSD 1,500$1,500Per plantVerified
Foreign GMP inspectionUSD 15,000–20,000$15,000–$20,000Per inspectionVerified
Local GMP inspectionUSD 100–300$100–$300Per inspectionVerified
Sample import licenceUSD 100$100Per licenceVerified
Import licenceUSD 100$100Per licenceVerified
Free-sale certificateUSD 50$50.00Per certificateVerified
WHO GMP certificateUSD 100$100Per certificateVerified
Clinical trial processing feeUSD 0–1,000$0.00–$1,000Per trialVerified
Agency transferUSD 1,000$1,000Per partyVerified
Advertisement processing fee (all categories)USD 1,000$1,000Per advertisementVerified
Sweden flagSweden
Swedish Medical Products Agency
Annual fee per registered role - manufacturers and authorised representativesSEK 30,000$3,264Per role, per yearVerified
Legacy/directive-product company registrationSEK 2,150$234Per yearVerified
Legacy/directive-product registration by product countSEK 1,000–10,000$109–$1,088Per yearVerified
Exemption from conformity assessment (MDR Art. 59 / IVDR Art. 54)SEK 62,000$6,746Per applicationVerified
Export certificate (MDR Art. 60 / IVDR Art. 55)SEK 1,300$141Per certificateVerified
Extended export certificateSEK 2,300$250Per certificateVerified
Clinical investigation / performance study - single-state procedureSEK 11,000–60,000$1,197–$6,528Per applicationVerified
Clinical investigation - multi-state procedure (MDR Art. 78)SEK 60,000–65,000$6,528–$7,072Per applicationVerified
Notified-body annual feeSEK 750,000$81,600Per yearVerified
Switzerland flagSwitzerland
Swissmedic
swissdamed Basic Fee - First UDI-DICHF 200$246First UDI-DI per manufacturer per calendar yearVerified
swissdamed Unit Fee - Additional UDI-DICHF 20$24.60Each additional UDI-DI in the same calendar yearVerified
swissdamed device registration - first device per yearCHF 200$246Annual, per manufacturerVerified
swissdamed device registration - each additional deviceCHF 20$24.60Annual, per additional deviceVerified
Taiwan flagTaiwan
TFDA
Class I device registration (查驗登記)TWD 15,000$469Per caseVerified
Class II device registration (查驗登記)TWD 58,000$1,814Per caseVerified
Class III device registration (查驗登記)TWD 100,000$3,128Per caseVerified
Export-only device registrationTWD 15,000$469Per caseVerified
Registration of new principle/structure/material/efficacy or no-predicate deviceTWD 130,000$4,066Per caseVerified
Priority-review registrationTWD 180,000$5,630Per caseVerified
World-first no-predicate device requiring foreign-manufacturer auditTWD 250,000$7,819Per caseVerified
Class I device filing (登錄)TWD 10,000$313Per caseVerified
Annual declaration of filed devicesTWD 2,000$62.56Per yearVerified
Licence extensionTWD 8,000$250Per caseVerified
Filing-item changeTWD 8,000$250Per caseVerified
Change of efficacy/use/indicationTWD 40,000$1,251Per caseVerified
Change of specificationTWD 35,000$1,095Per caseVerified
Dimension/spec change not involving safety-efficiency assessmentTWD 25,000$782Per caseVerified
Transfer, merger, country-of-origin or plant-relocation changeTWD 25,000$782Per caseVerified
Other licence changesTWD 10,000$313Per caseVerified
Licence reissue/exchangeTWD 1,500$46.92Per caseVerified
Foreign manufacturer QMS document reviewTWD 60,000$1,877Per QMS applicationVerified
Foreign QMS simplified low-risk review (Art. 78 reduced inspection)TWD 30,000$938When eligibleVerified
Foreign on-site QMS inspectionTWD 600,000$18,767Per inspectionVerified
GDP inspection (including one warehouse)TWD 30,000$938Per inspectionVerified
Clinical trial plan review / report reviewTWD 50,000$1,564Per reviewVerified
Domestic GCP on-site inspectionTWD 45,000$1,407Per visitVerified
Foreign GCP inspectionTWD 650,000$20,331Per countryVerified
Tanzania flagTanzania
TMDA
Imported non-registrable Class A device notificationUSD 50$50.00Per notificationVerified
Imported device - Class AUSD 500$500Per applicationVerified
Imported device - Class B/C/DUSD 2,500$2,500Per applicationVerified
Imported device - major variationUSD 300$300Per variationVerified
Imported device - minor variationUSD 150$150Per variationVerified
Annual retention - imported registered devicesUSD 200$200AnnualVerified
Annual retention - imported notified devicesUSD 50$50.00AnnualVerified
IVD imported - notificationUSD 100$100Per notificationVerified
IVD imported - Class AUSD 300$300Per applicationVerified
IVD imported - Class BUSD 1,000$1,000Per applicationVerified
IVD imported - Class CUSD 1,500$1,500Per applicationVerified
IVD imported - Class DUSD 2,000$2,000Per applicationVerified
Domestic device - notificationTZS 50,000$18.92Per notificationVerified
Domestic device - Class A registrationTZS 100,000$37.84Per registrationVerified
Domestic device - Class B registrationTZS 200,000$75.69Per registrationVerified
Domestic device - Class C/D registrationTZS 500,000$189Per registrationVerified
Domestic device - major variationTZS 150,000$56.76Per variationVerified
Domestic device - minor variationTZS 100,000$37.84Per variationVerified
Thailand flagThailand
TFDA
Class 1 - ApplicationTHB 500$15.09Per applicationVerified
Class 1 - Document Verification (Import)THB 600$18.11Per applicationVerified
Class 1 - Certificate (Import)THB 2,000$60.37Per certificateVerified
Class 2/3 - ApplicationTHB 1,000$30.19Per applicationVerified
Class 2/3 - Expert Fee (Import)THB 38,000$1,147Per applicationVerified
Class 2/3 - Certificate (Import)THB 10,000$302Per certificateVerified
Class 4 - ApplicationTHB 1,000$30.19Per applicationVerified
Class 4 - Expert Fee (Import)THB 53,000$1,600Per applicationVerified
Class 4 - Certificate (Import)THB 20,000$604Per certificateVerified
Importer establishment registration - statutory certificate feeTHB 4,000$121Per certificateVerified
Turkey flagTurkey
TITCK / UTS
Medical-device product registrationTRY 201–335$4.20–$7.00Per applicationVerified
Medical-device document registration - EC certificate or declaration of conformityTRY 335$7.00Per documentVerified
Medical-device and class determinationTRY 51,527$1,076Per deviceVerified
Free-sale certificate - 1–50 productsTRY 3,349$69.95Per certificateVerified
Free-sale certificate - 51–250 productsTRY 6,634$139Per certificateVerified
Free-sale certificate - over 250 productsTRY 9,918$207Per certificateVerified
Clinical investigation - first application, device without CE mark (thesis/academic excluded)TRY 57,967$1,211Per applicationVerified
Clinical investigation or performance study - CE-marked deviceTRY 2,576$53.80Per applicationVerified
Post-market clinical study - first applicationTRY 25,763$538Per applicationVerified
Clinical-investigation change applicationTRY 1,094$22.85Per applicationVerified
MDR/IVDR conformity-assessment exception applicationTRY 64,408$1,345Per applicationVerified
Certificate-extension application (Communiqué 2023/KK-1)TRY 4,637$96.85Per applicationVerified
Announcement application (Communiqué 2021/KK-3)TRY 4,637$96.85Per applicationVerified
Sales-center authorization certificate (Yetki Belgesi)TRY 3,617$75.54Per certificateVerified
Technical service - first activity certificateTRY 38,645$807Per certificateVerified
Notified body - initial/re-appointment applicationTRY 257,635$5,381Per applicationVerified
Notified body - assessmentTRY 772,906$16,143Per assessmentVerified
Notified body - annual surveillanceTRY 322,044$6,726AnnualVerified
Uganda flagUganda
NDA
Application for registration of imported surgical instruments and appliancesUSD 1500$1,500Per applicationVerified
Application for registration of locally manufactured surgical instruments and appliancesUSD 200$200Per applicationVerified
Retention of imported surgical instruments and appliances on the RegisterUSD 200$200Per yearVerified
Retention of locally manufactured surgical instruments and appliances on the RegisterUSD 100$100Per yearVerified
Major amendment of an application to register an imported surgical instrument or applianceUSD 500$500Per amendmentVerified
Minor amendment of an application to register an imported surgical instrument or applianceUSD 200$200Per amendmentVerified
Notification of amendmentUSD 50$50.00Per notificationVerified
Examination of surgical instruments and appliances by the Authority in the course of performing its functionsUSD 1000$1,000Per batchVerified
Ukraine flagUkraine
Ministry of Health
Responsible-person register notificationUAH 0$0Per notificationVerified
United Arab Emirates flagUnited Arab Emirates
EDE
Marketing-authorization application feeAED 100$27.23Per applicationVerified
Device RegistrationAED 5,000$1,361Per deviceVerified
Marketing-authorization renewal application feeAED 100$27.23Per renewal applicationVerified
Marketing-authorization renewal feeAED 2,500$681Per renewalVerified
Classification-of-a-product letterAED 500$136Per letterVerified
Import permit - application feeAED 100$27.23Per applicationVerified
Manufacturer (site) registration - application feeAED 100$27.23Per applicationVerified
Registration of a medical-products manufacturerAED 10,000$2,723Per registration, renewed every 5 yearsVerified
Domestic manufacturing-facility licence - approval of architectural plans and drawingsAED 2,000$545Per approvalVerified
Domestic manufacturing-facility licence - final licensing of pharmaceutical and medical facilitiesAED 50,000$13,615Per licenceVerified
Advertisement licence - application feeAED 100$27.23Per applicationVerified
Minor-variation (amendment) certificate for registered MA dataAED 1,000$272Per certificateVerified
United Kingdom flagUnited Kingdom
MHRA
Medical Device Registration Statutory Fee£300$406Per Level 2 GMDN category, annualVerified
Clinical Investigation - Initial Submission (Class I/IIa/IIb non-implantable)£15,309$20,721Per submissionVerified
Clinical Investigation - Initial Submission (Class IIb implantable/long-term invasive, Class III, active implantable)£32,016$43,334Per submissionVerified
Clinical Investigation - Resubmission (Class I/IIa/IIb non-implantable)£11,701$15,837Per resubmissionVerified
Clinical Investigation - Resubmission (Class IIb implantable, Class III, active implantable)£22,678$30,695Per resubmissionVerified
Certificate of Free Sale£75$102Per order (first 10 certificates)Verified
Regulatory advice meetingGBP 987$1,336Per meetingVerified
Statistical reviewGBP 852$1,153Per reviewVerified
UK Approved Body - initial designation applicationGBP 41,337$55,950Per applicationVerified
UK Approved Body - initial designation auditGBP 67,606$91,505Per auditVerified
UK Approved Body - surveillanceGBP 52,929$71,639Per surveillance activityVerified
UK Approved Body - day rateGBP 1,463$1,980Per assessor dayVerified
United States flagUnited States
FDA
Annual Establishment Registration$11,423$11,423Annual per facilityVerified
510(k) Review - Standard$26,067$26,067Per submissionVerified
510(k) Review - Small Business$6,517$6,517Per submissionVerified
513(g) Request - Standard$7,820$7,820Per requestVerified
513(g) Request - Small Business$3,910$3,910Per requestVerified
PMA/PDP/PMR/BLA - Standard$579,272$579,272Per submissionVerified
PMA/PDP/PMR/BLA - Small Business$144,818$144,818Per submissionVerified
De Novo Review - Standard$173,782$173,782Per submissionVerified
De Novo Review - Small Business$43,446$43,446Per submissionVerified
Panel-track Supplement - Standard$463,418$463,418Per supplementVerified
Panel-track Supplement - Small Business$115,855$115,855Per supplementVerified
180-Day Supplement - Standard$86,891$86,891Per supplementVerified
180-Day Supplement - Small Business$21,723$21,723Per supplementVerified
Real-Time Supplement - Standard$40,549$40,549Per supplementVerified
Real-Time Supplement - Small Business$10,137$10,137Per supplementVerified
BLA Efficacy Supplement - Standard$579,272$579,272Per supplementVerified
BLA Efficacy Supplement - Small Business$144,818$144,818Per supplementVerified
30-Day Notice - Standard$9,268$9,268Per noticeVerified
30-Day Notice - Small Business$4,634$4,634Per noticeVerified
Class III Periodic Reporting - Standard$20,275$20,275AnnualVerified
Class III Periodic Reporting - Small Business$5,069$5,069AnnualVerified
Uruguay flagUruguay
Ministry of Public Health
PIRM registration and MSP arancelado fees (indexed UR units)PIRM: 5 UR fixed + 25 UR families + professional stamps—Check before submissionOfficial source
Uzbekistan flagUzbekistan
Center for Pharmaceutical Product Safety (MoH)
Primary (preliminary) expertise of the application - Class IUZS 3,296,000 (8 BRV)$268Per applicationVerified
Primary (preliminary) expertise of the application - Classes IIa, IIb, IIIUZS 4,120,000 (10 BRV)$335Per applicationVerified
Specialised expertise and registration decision - Class I (non-sterile, non-measuring, non-invasive)UZS 11,536,000 (28 BRV)$938Per deviceVerified
Specialised expertise - Class I sterile, measuring, or invasiveUZS 18,540,000 (45 BRV)$1,507Per deviceVerified
Specialised expertise - Class I in vitro diagnosticUZS 18,128,000 (44 BRV)$1,474Per deviceVerified
Specialised expertise - Class IIa (device or IVD)UZS 20,600,000 (50 BRV)$1,675Per deviceVerified
Specialised expertise - Class IIbUZS 21,424,000–21,836,000 (52–53 BRV)$1,742–$1,775Per deviceVerified
Specialised expertise - Class IIIUZS 21,836,000–22,248,000 (53–54 BRV)$1,775–$1,809Per deviceVerified
Specialised expertise on the recognition route (FDA, CE, EMA, PMDA, MFDS, MHRA registrations)UZS 11,536,000–15,656,000 (28–38 BRV)$938–$1,273Per deviceVerified
Validity extension without laboratory testingUZS 11,536,000–14,420,000 (28–35 BRV)$938–$1,172Per renewalVerified
Vietnam flagVietnam
Ministry of Health / IMDA
Class A standards declarationVND 500,000$19.16Per dossierVerified
Class B standards declarationVND 1,500,000$57.48Per dossierVerified
Class C/D circulation-number applicationVND 3,000,000$115Per dossierVerified
Zambia flagZambia
ZAMRA
Application for marketing authorisation — allied substances imported as finished productsUS$ 500.00$500Per product applicationVerified
Annual retention fee — allied substances imported as finished productsUS$ 200.00$200Annually, for the life of the marketing authorisationVerified
Renewal of marketing authorisation — allied substances imported as finished productsUS$ 350.00$350Every five yearsVerified
Late submission of an application for renewal of marketing authorisationUS$ 5.00$5.00For each day the application is lateVerified
Evaluating additional information for an application — inadequate technical information (quality, safety or efficacy)US$ 400.00$400Per occurrenceVerified
Minor amendment to a marketing authorisationUS$ 100.00$100Per amendmentVerified
Major amendment to a marketing authorisationUS$ 500.00$500Per amendmentVerified
Zimbabwe flagZimbabwe
MCAZ
Retention of the right to sell a type or brand of condomUS$ 100.00$100Annually, payable on or before 1 AprilVerified
Package amendment for a condom type or brandUS$ 50.00$50.00Per amendmentVerified
MCAZ Medical Devices Laboratory — condom testing, private sector (all batch sizes)US$ 350.00$350Per batchVerified
MCAZ Medical Devices Laboratory — condom testing, public sector (all batch sizes)US$ 280.00$280Per batchVerified
MCAZ Medical Devices Laboratory — glove testing (all sizes)US$ 150.00$150Per batchVerified
Government fees only — excludes consulting, testing and local representative costs
About the data

How fee rows are verified

Every market links to a primary regulator source and carries a review date. A row is counted as verified only when that source supports the exact amount. Live tariffs, quotes, pending implementations, and unpublished amounts are labeled as such; they are never converted into a made-up zero or estimate.

USD equivalents use the displayed daily FX date and are budgeting figures. The payable amount is always the amount and currency named by the regulator; India and several other authorities denominate some official fees directly in USD.

akbpm.gov.al · AKBPM Order 734: amended medical-device registration procedure and application fee e-albania.al · e-Albania medical-device registration service miph.gov.dz · Algeria Executive Decree 21-551: redevance schedule for pharmaceutical products and medical devices boletinoficial.gob.ar · ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule arlis.am · Law of the Republic of Armenia on State Duty, Article 8 (base duty) and Article 16 point 35 (state registration of medicines, pharmaceutical products, medical devices, medical instruments, devices and equipment) tga.gov.au · TGA fees and charges summary from 1 July 2026
Verified1001 rows checked against primary regulator sources · Sep 16, 2026
What's the difference between registration fees and annual fees?
Registration fees are one-time payments to submit a device for approval; annual fees recur to maintain the registration. The frequency column states which rule applies to each row.
Do government fees include consulting or service costs?
No. Only mandatory payments to the regulator are listed. Consulting, testing, translation, local representation, and clinical costs are separate budget lines.
Are there small business discounts?
Some regulators publish reduced rates — for example FDA lists a qualified small-business 510(k) fee. Eligibility is regulator-specific; confirm it in the linked official schedule before paying.
Explore by country

Medical device government fees by country

Open a country fee schedule for regulator-specific application, review, renewal, and establishment costs.

🇦🇱 Albania government feesAKBPM🇩🇿 Algeria government feesANPP🇦🇷 Argentina government feesANMAT🇦🇲 Armenia government feesMinistry of Health🇦🇺 Australia government feesTGA🇦🇹 Austria government feesBASG🇧🇭 Bahrain government feesNHRA🇧🇩 Bangladesh government feesDGDA🇧🇾 Belarus government feesMinistry of Health🇧🇪 Belgium government feesFAMHP🇧🇴 Bolivia government feesAGEMED🇧🇦 Bosnia and Herzegovina government feesALMBiH🇧🇷 Brazil government feesANVISA🇧🇬 Bulgaria government feesBDA🇨🇦 Canada government feesHealth Canada🇨🇱 Chile government feesISP/ANDIM🇨🇳 China government feesNMPA🇨🇴 Colombia government feesINVIMA🇨🇷 Costa Rica government feesMinistry of Health🇨🇮 Côte d'Ivoire government feesAIRP🇭🇷 Croatia government feesHALMED🇨🇺 Cuba government feesCECMED🇨🇿 Czech Republic government feesSÚKL🇩🇰 Denmark government feesDanish Medicines Agency🇩🇴 Dominican Republic government feesDIGEMAPS🇪🇨 Ecuador government feesARCSA🇪🇬 Egypt government feesEDA🇪🇪 Estonia government feesRavimiamet🇪🇹 Ethiopia government feesEFDA🇪🇺 European Union government feesEU MDR🇫🇮 Finland government feesFimea🇫🇷 France government feesANSM🇬🇪 Georgia government feesRegulation Agency for Medical and Pharmaceutical Activities (RAMA)🇩🇪 Germany government feesBfArM🇬🇭 Ghana government feesFDA Ghana🇬🇷 Greece government feesEOF🇬🇹 Guatemala government feesMSPAS🇭🇰 Hong Kong government feesMDD🇭🇺 Hungary government feesNNGYK🇮🇸 Iceland government feesLyfjastofnun🇮🇳 India government feesCDSCO🇮🇩 Indonesia government feesMinistry of Health🇮🇷 Iran government feesIran FDA🇮🇶 Iraq government feesMinistry of Health🇮🇪 Ireland government feesHPRA🇮🇱 Israel government feesAMAR🇮🇹 Italy government feesMinistry of Health🇯🇵 Japan government feesPMDA🇯🇴 Jordan government feesJFDA🇰🇿 Kazakhstan government feesCommittee for Medical and Pharmaceutical Control🇰🇪 Kenya government feesPPB🇱🇻 Latvia government feesZVA🇱🇧 Lebanon government feesMinistry of Public Health🇱🇮 Liechtenstein government feesOffice of Public Health🇱🇹 Lithuania government feesVASPVT🇲🇴 Macau government feesISAF🇲🇾 Malaysia government feesMDA🇲🇹 Malta government feesMedicines Authority🇲🇽 Mexico government feesCOFEPRIS🇲🇩 Moldova government feesAMDM🇲🇳 Mongolia government feesMedicines and Medical Devices Regulatory Agency (MMRA)🇲🇪 Montenegro government feesCInMED🇲🇦 Morocco government feesAMMPS🇳🇱 Netherlands government feesIGJ🇳🇿 New Zealand government feesMedsafe🇳🇬 Nigeria government feesNAFDAC🇲🇰 North Macedonia government feesMALMED🇳🇴 Norway government feesNorwegian Medical Products Agency🇴🇲 Oman government feesMinistry of Health🇵🇰 Pakistan government feesDRAP🇵🇦 Panama government feesMinistry of Health🇵🇾 Paraguay government feesDINAVISA🇵🇪 Peru government feesDIGEMID🇵🇭 Philippines government feesFDA Philippines🇵🇱 Poland government feesURPL🇵🇹 Portugal government feesINFARMED🇷🇴 Romania government feesANMDMR🇷🇺 Russia government feesRoszdravnadzor🇷🇼 Rwanda government feesRwanda FDA🇸🇦 Saudi Arabia government feesSFDA🇸🇳 Senegal government feesAgence sénégalaise de Réglementation pharmaceutique (ARP)🇷🇸 Serbia government feesALIMS🇸🇬 Singapore government feesHSA🇸🇰 Slovakia government feesŠÚKL🇸🇮 Slovenia government feesJAZMP🇿🇦 South Africa government feesSAHPRA🇰🇷 South Korea government feesMFDS🇪🇸 Spain government feesAEMPS🇱🇰 Sri Lanka government feesNMRA🇸🇪 Sweden government feesSwedish Medical Products Agency🇨🇭 Switzerland government feesSwissmedic🇹🇼 Taiwan government feesTFDA🇹🇿 Tanzania government feesTMDA🇹🇭 Thailand government feesThai FDA🇹🇷 Turkey government feesTITCK🇺🇬 Uganda government feesNDA🇺🇦 Ukraine government feesDLS🇦🇪 United Arab Emirates government feesEDE🇬🇧 United Kingdom government feesMHRA🇺🇸 United States government feesFDA🇺🇾 Uruguay government feesMinistry of Public Health🇺🇿 Uzbekistan government feesPharmaceutical Safety Center🇻🇳 Vietnam government feesMinistry of Health🇿🇲 Zambia government feesZAMRA🇿🇼 Zimbabwe government feesMCAZ