Fees by country

An audit fee must be paid only when an application is selected for mandatory audit by law; no audit fee is payable when an application is selected for non mandatory audit, and the audit cannot start until fees are paid.

The Licensing Authority will not register (or renew the registration of) any drug, including devices, unless the fee determined under the rules is paid; registration, renewal and, as applicable, late fees are determined by rules and may be revised by the Government from time to time by gazette notification.

The state duty for state registration (reregistration) becomes payable only after the Ministry's decision: the Ministry notifies the applicant within 5 working days of the decision and the duty obligation; the certificate is issued within 5 working days after the applicant confirms payment into the republican budget (payment via the ERIP system).

Retailers supplying devices to consumers for purely non professional use are exempt from the turnover tax. A taxpayer who is only a distributor and who has declared in the FAMHP online applications that it complies with the self check guide is exempted from the contribution for economic operators; if its turnover is below EUR 40,000 (indexed), it is also exempted from the turnover tax and pays nothing, but must still complete the annual declaration.

Economic operators declare their turnover annually via the 'Contributions' application of the FAMHP portal using the 'Declaration' form; the declaration must be certified by an auditor or chartered accountant and uploaded as a scan. An invoice is issued at the beginning of the next calendar year and payment must wait for that invoice.

The TFVS surveillance fee (instituted by Lei 9.782/1999) must be paid before petitioning any request to ANVISA, such as registration applications; payment is by GRU, valid for 30 days from emission.

Fees for registration and issuance of registration certificates, for permits and certificates under ЗМИ, and for entry of changes therein are charged in amounts set by a tariff approved by the Council of Ministers (Тарифа, adopted by Decree ПМС № 339 of 09.12.2011, amended by Decree № 359 of 29.12.2025, effective 01.01.2026).

Tariff fees are payable upon submission of the application/request for the service or inspection; if a started procedure is terminated, the paid fee is not refunded. From 01.01.2026 the tariff fees are denominated in euro; during the dual circulation period payment in BGN cash is allowed at the official fixed rate.

No MDL application fees apply for: Class I medical devices, custom made medical devices, medical devices for special access, and medical devices for investigational testing involving human subjects.

There is no fee for amending a Medical Device Establishment Licence or for making a section 48 notification; fees apply only to new MDEL applications, Annual Licence Review and reinstatement applications, equally to foreign and domestic establishments.

Registration fees are waived for innovative medical device registration applications filed by small and micro enterprises (小微企业), per the NMPA administrative licensing fee schedule.

Microenterprises (including small producers per Decreto 691 de 2018) are exempt from payment of device registration fees under parágrafo 2 of Art. 2 of Ley 2069 de 2020; small and medium companies pay differentiated tariffs of 40 90% of the standard fee under Art. 2 parágrafo 1 of Ley 2069 de 2020 and Art. 5 of Decreto 1889 de 2021, by income bands.

A single application (trámite) implies a single fee payment, even where multiple products are grouped (family, group, family of groups, system, test kit, multiple presentations).

CECMED services are charged in Cuban Pesos (CUP) for national entities operating in that currency and in Cuban Convertible Pesos (CUC) for foreign entities and Cuban entities operating in CUC. Payment abroad is by bank transfer in any freely convertible currency (except USD) equivalent to CUC at the day's rate; payment is due only after the service application has been accepted, and all services pay 100% of the tariff upon acceptance of the application.

Procedures relating to donations are not subject to CECMED service charges (Art. 3(f) of the fee Reglamento). This aligns with E 132 25 epígrafe 3.58, under which CECMED establishes regulatory requirements for device donations and controls compliance.

In exceptional cases with sufficient justification, CECMED may authorize, at the holder's request, extension of a product or operations licence that reached expiry without renewal for reasons attributable to the client, for a limited period of up to six months. The penalty for the procedure extension service is 20% of the procedure value for each month of extension requested. If the delay is attributable to CECMED, the validity is extended at no cost to the client.

The applicant receives a call to pay the administrative fee within 15 days (payment identified by an assigned variable symbol); if the applicant does not evidence payment of the fee within the deadline, the administrative proceedings are stopped. Fees are charged under Act No. 634/2004 Sb. on administrative fees.

No annual supervision fee is due for the calendar year in which a company first starts marketing/importing/distributing only in the last 3 months of the year; a company that ceases its business and informs the Danish Medicines Agency within the first 3 months of the year owes no annual fee for that calendar year. Companies starting in the first 9 months pay the full annual fee for the registration year.

An importer/distributor covering device types in both fee annexes (class I/IVD and class IIa III) pays only one annual fee, set at the higher annex 2 (class IIa/IIb/III) rate. A manufacturer covered by both the class I/IVD rule and the class IIa III rule likewise pays only the class IIa III annual fee.

The Danish Medicines Agency may, in wholly exceptional cases, exempt a payer from the fees chargeable under the device fee regulations (registration fees, annual fees, classification dispute fee, clinical investigation fees, etc.).

The fee rates in the Danish device fee regulations are adjusted once a year on 1 January using the Finance Ministry's rate for the general price and pay index; amounts are rounded to whole kroner and the current fees are published on the Danish Medicines Agency's website, where invoice/website amounts are authoritative over the regulation text.

The Danish scientific ethics committees collect their fee from the sponsor for handling clinical investigation and performance study applications/amendments and may decline to begin processing an application or amendment if the fee is not paid on time; the fee is payable within one month of demand. Re processing of a previously negatively assessed project requires a new fee.

Inscription, re registration and modification of device registrations are subject to payment of the amounts set in ARCSA's current fee (tasas) regulations; statutory basis is LOS Art. 138 (the competent entity fixes the charge) and Acuerdo Ministerial No. 112 (R.O. 298, 19 Mar 2008), the regulation for charging for Art. 138 LOS procedures.

Notifications to the sanitary registration (per Resolución ARCSA DE 2023 005 AKRG) carry no payment, the voluntary cancellation of a registration has no cost, and the modification for risk reclassification ordered by ARCSA under the 2026 norm is free of any charge.

The MDR establishes no EU level fee: it only leaves Member States free to levy fees for activities under the Regulation, provided the fee level is set transparently and on the basis of cost recovery principles, with the structure and level of fees made publicly available on request and notified to the Commission and other Member States three months before adoption (Art. 111 MDR; identical rule Art. 104 IVDR). Notified body certification fees are charged commercially by the (mostly private) notified bodies.

Notified bodies must establish lists of their standard fees for the conformity assessment activities they carry out and make those lists publicly available (Art. 50 MDR).

An operator that has failed to meet its 49 § notification duty is charged the annual supervision fee increased by 100 percent; the increased fee may be collected retroactively within three years from the start of the calendar year following the year in which fee liability would have begun; Fimea may waive the increase where the neglect is minor.

The annual supervision fee is set for each calendar year and falls due annually on a date determined by Fimea, at the earliest on the last day of May; Fimea sends the fee decision to fee liable operators at least 30 days before the due date.

No fee is charged for handling a clinical investigation or performance study application/notification made without external funding by a private researcher, research group, university department, university hospital clinic, university veterinary hospital or the Finnish Institute for Health and Welfare (THL); the fee still applies if, for example, the device was supplied free of charge by a party entitled to exploit the study data in product development or assessments.

ANSM's list of operations giving rise to payment of a duty contains no medical device operations (all listed operations concern medicinal products and pharmacopoeia); the tariffs are fixed by Art. D5321 7 CSP and ANSM itself collects no tax.

Persons making the first sale (invoicing) in France of medical devices and IVDs must declare annual sales to ANSM at the latest by 31 March of the current year using the bordereau form (also transmitted to CEPS); no payment is due the former contribution (Art. L245 5 5 1 Code de la sécurité sociale) was abolished from 1 January 2021 and declarants with turnover below EUR 500,000 are exempt from declaring.

Registration application fees are non refundable and are set per the FDA Fee Schedule; fees are prescribed by legislative instrument under s.147 of Act 851, and imported device registration fees are denominated in USD collected as cedi equivalent ('Cedi Equivalent of USD$').

From 1 December 2024, under the provisions of Law 5135/2024, the additional 2.4% stamp duty (χαρτόσημο/χαρτόσημο υπέρ του Δημοσίου 2,4%) previously added to EOF fees (including medical device register and clinical investigation fees) no longer applies.

No fee is charged by the Government for inclusion of devices into the Lists of Medical Devices or for applications for such inclusion; applicants bear only third party costs such as conformity assessment body certification charges.

Administrative service fees for fee charged device/IVD procedures must be transferred to the NNGYK bank account from 31 July 2023; the payment reference must start with 'ORVOSTECHNIKA' followed by the case (APP) number, and proof of payment must be attached to the submission.

If the fee payment is omitted, the application/notification is rejected (visszautasítás); stated for clinical investigation applications and notifications to NNGYK.

Every izin edar application is subject to a non tax state revenue (PNBP) charge payable by e payment (manual only in force majeure); fees already paid cannot be refunded, including for expired or rejected applications.

The one off national registration administration fee (fee code 431, EUR 150) is not charged where the economic operator registers directly on EUDAMED; all entities established in Ireland under the MDR and IVDR remain subject to the annual maintenance fees.

The decree itself charges no EUDAMED registration fee: the Ministry of Health may use the MDR Art. 31 data to introduce, by decree adopted with the Ministry of Economy and Finance, a tariff on manufacturers, authorised representatives and importers, taking account of the real cost of services and the economic value of the operations, in line with MDR Art. 111.

The Prime Minister, upon recommendation of the Minister of Health, may exempt batches imported as gifts/donations to a government entity from the per batch testing/circulation fees of Art. 13(a) of Testing Regulation 41/2024.

The application fee is payable at the time of submission via the PPB online portal and evaluation fees upon acceptance for evaluation; application fees are non refundable once the application has been successfully submitted, and evaluation fees are non refundable once the application is accepted regardless of the final decision withdrawal after acceptance or rejection by PPB results in forfeiture of evaluation fees. IBR route fees are charged immediately upon successful submission and are not refunded if the application fails the criteria.

Application fees under the regime must be paid when the application is submitted and are not refunded if the application is not accepted, is refused, or the dossier is archived.

If requested information is not provided within the stipulated time the registration application is rejected and the application fee is not refundable, without prejudice to the right to make a new application.

For modifications other than holder name changes, renewals or prórrogas of the registrations listed in LFD Art. 195 A (including device registrations), the fee payable is 75% of the corresponding registration fee.

For modifications of the holder's name or corporate name or any other change regarding the holder of registrations under LFD Art. 195 A, the fee payable is 50% of the corresponding registration fee.

The Minister of VWS may charge the costs of activities carried out under Regulations (EU) 2017/745, 2017/746 and 2019/1020 to the person for whom they are performed; the amounts are set by ministerial regulation.

WAND notification is free of charge: there is no notification fee and there are no on going fees for maintaining a device in the database.

There are no fees for processing applications and notifications of clinical investigations of medical devices at DMP.

There are no fees for applications and notifications of performance studies of IVD medical devices at the Norwegian Medical Products Agency.

The Medical Devices Act allows market actors and technical control bodies to be ordered to cover costs of supervision and control, and empowers the ministry to prescribe fees for processing clinical investigation and performance evaluation applications; no such application fees are currently charged.

Schedule C of the Medical Devices Rules, 2017 originally set the fees and rule 63(2) lets the Authority amend Schedule C with Policy Board approval; fee setting has since moved to notifications issued under section 20(1) of the DRAP Act 2012 read with rule 4(3) of the DRAP (Fee and Levy) Rules, 2022. The current instrument, S.R.O. 1399(I)/2025 (Islamabad, 1 August 2025), partially modifies S.R.O. 496(I)/2023 dated 17 April 2023 and supersedes S.R.O. 1324(I)/2024 dated 30 August 2024, with the approval of the Policy Board.

Rule 69 (substituted by S.R.O. 559(I)/2022) makes any fee specified under rule 63 and deposited in respect of any activity non refundable; S.R.O. 1399(I)/2025 restates this for all regulatory services.

Costs of the Licencia de Operación, Certificado de Libre Venta, BPM/BPA/BPD certificates, the Registro Sanitario and similar certifications are set by the health authority together with DNDM and updated by executive decree; DNDM income is used exclusively to fund its services and staff training. DNDM function 27 includes ensuring payment of regulated tariffs.

Pending draft decree fee table (Art. 22), payable with the application: Licencia de Operación B/.300 (fábrica), B/.250 (acondicionadora), B/.350 (distribuidora), B/.150 (minorista), B/.350 (almacén); new Registro Sanitario B/.400 (class B) and B/.550 (classes C/D); class A inscription B/.150 (tiered to B/.750 for families of 51 100); renewals B/.300 (B) / B/.450 (C,D); Certificado de Libre Venta B/.500; import authorization B/.100; family registrations B/.600 B/.1,000.

A Legal Research Fee (LRF) of 1% of the fee is added to FDA charges, pursuant to FDA Circular 2011 003 (RA 3870 as amended by PD 200 and PD 1856); all quoted CDRRHR fees are inclusive of this LRF where shown.

The URPL certificate confirming that non CE marked investigational devices and medicinal products without marketing authorisation are intended for a clinical investigation (the basis for import) is issued free of charge at the sponsor's request; the same rule applies to performance study devices.

Costs of acts and services of the competent authority and of the authority responsible for notified bodies (notifications, on site visits and assessments, monitoring of notified bodies and their subcontractors) are charged to applicants; the fee table is set by portaria of the member of Government for health after hearing INFARMED.

Non commercial clinical investigations and IVD performance studies, and studies where the sponsor is the investigator, are exempt from the INFARMED fees for investigation/performance study applications, notifications and substantial modifications.

ALIMS does not charge tariffs for activities relating to medical devices from donations and humanitarian aid, EU donation programmes, in emergency situations, or for activities performed at the request of the Ministry. The same exemption is restated in Art. 29 of the 2023 fee decision.

The 750 €/430 € ŠÚKL fee for registration/notification by an SR seated manufacturer or EC representative is payable after filing (against an invoice based on the Návrh na vyúčtovanie) and is a condition of registration; it is not returned if the registration/notification is refused.

If ŠÚKL rejects the application for authorisation of a clinical investigation of a medical device, the 500 € administrative fee is not returned. Fees are paid via the eKolok payment system (operated by Slovenská pošta) against a payment order (platobný predpis) issued by ŠÚKL after receipt of the application.

The national distributor/importer registration procedure with JAZMP (and its change/deletion procedures) charges no procedural cost: the SPOT government page states 'Stroškov postopka ni.'

Under Art. 32 ZMedPri 1, applicants pay JAZMP a fee for procedures under the act and the two regulations, and notified bodies, manufacturers, authorised representatives, importers, distributors (except Art. 21(4) only distributors), custom made manufacturers, reprocessors and in house producing health institutions pay JAZMP annual fees funding system maintenance and market surveillance; the fee basis is net annual revenue from device activity (total net revenue without separate accounting); amounts and payment methods are set in the Tarifa issued by the JAZMP council.

An annual licence retention fee (R4,400 under the 2025 fee regulations) is payable in respect of a licence issued under section 22C(1)(b) on or before the last working day of June each year, failing which the licence may be revoked.

The transfer of commercialization communications from the old registers to the new Registro de comercialización (RECOPS) is exempt from payment of the corresponding fee.

Läkemedelsverket may, if there are särskilda skäl (special reasons) in the individual case, repay or reduce a fee in whole or in part; courts have held that low turnover/income alone is not a special reason, and de registration can qualify for a pro rata reduction in the agency's practice.

If deregistration with Läkemedelsverket (or inactivation of the actor status in Eudamed) is made before 1 February, the activity is not invoiced the annual fee for that year; no products may be placed on the market (sold/rented/lent) after deregistration or inactivation.

An application for exemption from the national Swedish language requirements currently carries no fee, whereas an application for exemption from conformity assessment (dispens under MDR Art. 59 / IVDR Art. 54) costs SEK 62,000.

The TİTCK 2026 fee schedule applies a reduced fee ('Türkiye'de Üretilen Ürün Desteği — Evet/%40') for many device related services when the product is manufactured in Turkey, i.e. a 40% domestic product support/discount on the corresponding fee.

Maintaining the Register of responsible persons is financed from the state budget (and other legally permitted sources); MoH Order 122 prescribes no charge for submitting a notification to the Register.

A statutory fee must be paid to the Secretary of State as part of device registration (fee authority: regulation 53 of the Medical Devices Regulations 2002); the fee is chargeable per Level 2 GMDN Category (or Level 1 where no Level 2 exists) and under the current scheme is an annual fee rather than a one off registration charge.

For registration purposes the tariffs in force (aranceles vigentes) apply, i.e. the fee schedule is set outside Decreto 3/008 itself and is collected through MSP Tesorería and the VUCE trámite charges.

The TECM trámite for the MSP negative certificate / customs clearance (desaduanamiento) certificate for importing medical equipment and devices has no cost.

A fee (йиғим) is levied for reviewing a device registration application; the amounts are approved by the Ministry of Health in agreement with the Ministry of Economy and Finance, the Business Ombudsman and the Chamber of Commerce and Industry, and are transferred to the Centre's personal treasury account. The fee is not refunded if the applicant withdraws the application or registration is refused.

No fee is charged for considering an application to re issue the registration certificate (e.g. after reorganization or renaming with unchanged production site and technologies); the certificate is re issued within 5 working days.

Health sector fees, including medical device dossier fees under the TT 59/2023/TT BTC schedule, are collected at 50% from 01/07/2025 to 31/12/2026; full rates apply again from 01/01/2027.