Fees by country

A state duty is charged for the state registration of medical devices and for the examinations carried out in that connection, in the procedure and amount established by the Law on State Duty. For the state registration of medical purpose articles, medical instruments, devices and equipment the duty is 10 times the base duty for class 1, 20 times the base duty for class 2 and 30 times the base duty for class 3; for in vitro diagnostic means the duty is 20 times the base duty. The base duty is 1,000 drams. The resulting amounts are 10,000 drams (class 1), 20,000 drams (class 2), 30,000 drams (class 3) and 20,000 drams (in vitro diagnostic means). Re issuing a registration certificate in connection with changes that do not affect the safety, effectiveness and quality of the product costs 5 times the base duty (5,000 drams). A state duty is also charged for the grant of the import (conformity) certificate and for manufacture and servicing licences.

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.

For a device made in a dosed pharmaceutical form from natural or synthetic substances and containing a medicinal substance, the Analytical Expertise Centre conducts the expertise within 30 calendar days; if the application and documents show no deficiencies the Centre sends the applicant, within 5 working days, a written or electronic notice and a contract form, and the applicant must pay the expertise price under the contract to the Centre's bank account within 5 working days. If the applicant does not cure identified errors or supply the additional information within the 10 calendar day period, the expertise is halted and neither the samples nor the contract price are returned.

Art. 6.10 of the Law on Medicinal Products provides that for state registration, re registration and registration of changes to registration documents, and for issue of a hygiene certificate, a state duty in the amount fixed by the Law on State Duty is paid. Art. 1 1 provides that, for the purposes of the Law, medical devices are treated as equivalent to medicinal products except for an enumerated list of articles; Art. 6.10 is not on that list, so the duty provision applies to device registration.

For state registration, re registration or registration of a change to the registration documents of a medical device, the applicant must pay the state duty under the Law of the Republic of Azerbaijan 'On State Duty' within 5 (five) working days after receiving the notification from the Analytical Expertise Center. A duplicate certificate issued on loss or damage of the original does not attract a state duty.

The Law on State Duty sets the state duty for state registration of medicinal products and substances at 100 manat (Art. 33.1), and 15 manat for issue of a hygiene certificate (Art. 33.2). This is the duty that a medical device applicant must pay within five working days of the Analytical Expertise Centre's notification under §6.16 of the CM 345 registration Rules, because Art. 1 1 of the Law on Medicinal Products treats medical devices as medicinal products for the purposes of the Law, and Art. 6.10 (state duty for registration, re registration and registration of changes) is not among the articles excluded from that equivalence.

NHRA Circular No. (15) of 2026, dated 9 June 2026, publishes the updated medical device and supplies fee schedule applicable from 1 May 2026 unless NHRA instructs otherwise. Annex 1 Table 2 states that all medical device registrations have a three year validity: registration or renewal costs BHD 150 for low risk, BHD 300 for medium risk and BHD 1,000 for high risk, per three year licence. The application submission fee is BHD 5 per application; the medical device and supplies traceability fee is BHD 5 per individual device; updating device registration data costs BHD 20 per device.

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).

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.

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.

statement: The AGEMED fee schedule for registration services sets, among others: imported medical device, registration inscription 1.489; national medical device, inscription 993; national medical device, reinscription 745; imported diagnostic reagent, inscription 1.241; imported prosthesis or implant, inscription 1.737; national prosthesis or implant, inscription 869; and a second evaluation of a registration dossier, 621. Amounts are in bolivianos (Bs). · article: Items 82 99 and 102

statement: The AGEMED form listing the requirements for opening a medical device importing firm states the registration cost as item 34, 'Firmas Importadoras de Dispositivos Médicos — Evaluación e Inspección por apertura', Bs 4.964, in compliance with Resolución Ministerial N° 265. · article: Item 34

Retention of a listed or registered device on the respective register is an annual process that involves payment of an applicable annual fee and submission of any additional product information BoMRA prescribes. The guideline grounds the duty in the MRSA 2013 requirement to submit information annually accompanied by a retention fee, and runs the process on the BRIMS self service portal, where a quotation is generated and the product is retained once the fee is paid.

The draft Medicines and Related Substances (Fees, Levies and Penalties) Regulations, 2026 would set medical device registration fees by risk class, with separate schedules for international applicants (in USD) and local applicants (in BWP). For international applicants the draft Schedule 4.3 lists Class A and notifiable USD 185, Class B USD 1,110 and Class C and D USD 1,555, with an annual retention fee for all products of USD 1,500 and variation fees of USD 225 (major), USD 150 (minor) and USD 75 (notification).

BoMRA's import/export guideline lists the paid services of the import export control unit for medical devices: application to import/export medical devices P50; application for a transit permit P100; and an importation fee of 0.15% of the value of the consignment for all other products. The importation fee is invoiced from the supplier's invoice after the consignment arrives, paid against a sales order, and proof of payment is required before a subsequent permit is issued.

Every application must be accompanied by the appropriate fees specified in the Fees and Charges Regulations (Schedule 5 of the Medicines and Related Substances Regulations 2019) in force at the time of application. Screening fees are paid when the application is lodged for screening and evaluation fees when it is lodged for evaluation; an application not accompanied by the appropriate fees is not accepted, and all fees are non refundable once paid.

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.

AITI's Schedule 2 prices Dealer Type Approval per brand and model by equipment level and validity: Level 1 (telephone systems, fax, PABX, fixed ADSL modem, audio and video conferencing, short range devices, VoIP) BND 20 for 1 year up to BND 100 for 5 years; Level 2 BND 30 to 50 per year depending on equipment type; Level 3 (mobile phones, wireless modems, base stations, radar, radio data transceivers, high power radio, walkie talkies, repeater stations) BND 50 for 1 year up to BND 250 for 5 years. Schedule 3 prices the Dealer Import Permit at BND 20 per unit for listed equipment only, with short range devices, modems and mobile phones among the exempt types.

Schedule 5 of the Medicines (Licensing, Standard Provisions and Fees) Regulations is Brunei's only fee tariff for health products. Its five heads are product licence (processing fee $200; first year no charge; $50 each subsequent year; major amendment $150, minor $50), import licence, wholesale dealer's licence ($100 per year), manufacturer's licence and certificates (certificate to export a medicinal product $50; statement of licensing status $25). No head prices any medical device application, because none exists.

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.

Annex 1 row 11 of Joint Prakas 1356/2016 prices the letter authorising import of medicines, medical devices and cosmetics at 200,000 riel, with a 10 working day maximum service time and a validity of one month (the annex's validity column reads ១ខែ).

Article 8 of Prakas 4206 provides that the service fee for a request to vary a product holding a visa registration is determined by joint prakas between the Minister of Health and the Minister of Economy and Finance.

Annex 1 of Joint Prakas No. 1356 MEF.PrK of 18 November 2016 (tariff of public services provided by the Ministry of Health) row 8 'issuance of a visa registration certificate' prices medical devices, reagents, external use health support products, traditional medicines and health supplements at 400,000 riel per service unit, with a maximum service time of 100 working days and a validity of 3 years; the same row prices medicines at 1,000,000 riel, 270 working days and 5 years.

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).

The base fee for device registration is fixed by type, class and presentation according to risk level. In CFA francs: declaration 10 000 for every class; registration (base fee) 50 000 (class A), 250 000 (B), 500 000 (C), 1 000 000 (D), 2 500 000 (DMDIV class D); major variation the same as the base fee at each class; minor variation 10 000 / 25 000 / 50 000 / 100 000 / 250 000; renewal 25 000 / 125 000 / 250 000 / 500 000 / 1 250 000. The base fee is reduced by half for medical devices manufactured within the UEMOA area. Payment is by crossed bank cheque to the order of the Autorité Ivoirienne de Régulation Pharmaceutique. A separate line priced at 10 000 covers the declaration of laboratory reagents for medical biology.

HALMED charges fixed fees for medical device procedures under group 8 of its price list, in euro excluding VAT, under a price list in force since 9 March 2024 with amendments effective 1 July 2024 and 1 April 2025. Key items: entry in the register of manufacturers or manufacturer representatives 700,00 EUR, change of registration 200,00 EUR; entry in the register of medical devices 800,00 EUR for 1 5 products, 900,00 EUR for 6 30 products and 1.000,00 EUR for more than 30; change of an entry in the register of medical devices 300,00 EUR (200,00 EUR where the registration decision is unchanged); risk classification of a medical device 1.000,00 EUR plus additional costs if an external expert is engaged; issue of an SRN 400,00 EUR (micro), 600,00 EUR (small) and 800,00 EUR (medium/large); free sale certificate per country 150,00 380,00 EUR depending on the number of products; entry in the distributor register 400,00 1.050,00 EUR depending on enterprise size and number of branches; maintenance of manufacturer/authorised representative status in Croatia 200,00 800,00 EUR by number of products, and of importer status 250,00 EUR (the price list does not state the period of the maintenance fee; its footnote says items 10 19 begin to be charged under MDR Articles 29 and 30, the EUDAMED registration duty).

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.

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.

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.).

statement: The MSP publishes the cost of the simplified registration procedure for the 'Productos Sanitarios' modality as RD$18,000.00 for a new registration and RD$18,000.00 for a renewal, payable by deposit or certified cheque to the Tesorería Nacional account at Banco de Reservas. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

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.

Ravimiamet may provide paid services connected with its main activity that ensure compliance with medical device quality and safety requirements, and the charge for one service may not exceed 20,000 euro. The list of paid services and the rates are established by regulation of the minister responsible for the field.

EFDA/GDL/046 Table 6 fixes the medical device registration service fees under the Rate of Service Fees issued by Council of Ministers Regulation No. 370/2015: new application screening 350 birr; new application evaluation 1,300 birr; laboratory test USD 200; renewal application evaluation 870 birr; major variation application evaluation 870 birr; minor variation application evaluation 650 birr; agency agreement USD 50. All fees are payable before submitting the dossier or in parallel with the application submission. Applicants complete the payment request forms annexed to the guideline and obtain the Authority's approval before payment.

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).

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.

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.

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.

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.

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.

The published cost of the medical device sanitary inscription procedure is Q 100 (one hundred quetzales). The same amount is shown for the renewal variant of the procedure.

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.

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

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.

The fees Lyfjastofnun may charge for medical devices are set by the Minister under Article 39 of Act No. 132/2020 in the fee schedule (gjaldskrá). The schedule in force is Gjaldskrá nr. 1529 of 17 December 2025 (in force 1 January 2026, repealing gjaldskrá nr. 1555/2023). Its device articles are: 1. gr. certificates (Free Sales Certificate, five copies, ISK 53,400; each further copy of a device or IVD FSC beyond five, ISK 26,700; other certificates ISK 40,050 per copy); 2. gr. distributor registration (registration ISK 53,400; maintenance registration ISK 26,700); 3. gr. supervision of use (device/IVD ISK 160,200; management system ISK 387,150) and assessment of applications to use a device that does not meet the requirements, in the interest of public health or patient safety (Class IIa and non invasive Class IIb/III devices ISK 200,250; Class IIb/III including implantable devices, invasive devices for long term use and IVDs ISK 293,700; other exemptions ISK 200,250); 4. gr. supervision of maintenance (device ISK 200,250; management system ISK 387,150); 5. gr. supervision of operators (market surveillance of distributors/importers ISK 133,500; their quality management ISK 387,150; market surveillance of manufacturers/authorised representatives ISK 133,500; their quality management ISK 774,300); 6. gr. clinical investigations (pre check ISK 200,250 in both class bands; assessment of a clinical investigation application, all classes, ISK 1,161,450; approved clinical investigation ISK 387,150; changes ISK 106,800); 7. gr. hourly rate ISK 26,700 per specialist hour.

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.

statement: The State Agency of Medicines fee schedule (Cabinet Regulation No. 895 of 18 December 2024, in force 1 January 2025) fixes an annual medical device vigilance system fee of EUR 105.20 for class I devices and other (remaining) and class A IVDs, and EUR 201.90 for class IIa, IIb and III devices, A list, B list and self test, class B, C and D IVDs payable per manufacturer, authorised representative or distributor. Issuing a medical device free sale certificate costs EUR 185.41, and the examination of an application and documentation to place on the market individual devices that have not undergone conformity assessment and are not CE marked costs EUR 528.60. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: No

The Health Engineering Service (مصلحة الهندسة الصحية) of the MOPH grants entry permits after verifying that the legal conditions are met, in particular the conformity certificate issued by the Industrial Research Institute, and after payment of the charge imposed by Law No. 193 of 18 November 2011 (amending certain provisions of the retirement fund law of each of the Beirut and Tripoli physicians' syndicates), payable to the physicians' syndicate in accordance with joint decision No. 180/1 of 15 February 2012 of the Ministers of Public Health and Finance. The competent ministry departments do not endorse customs declarations unless the declaration is accompanied by those documents.

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.

Medical device fees are set in Schedule 5 of the Medicines Authority (Fees) Regulations S.L. 458.46, added by Legal Notice 254 of 2025. Key amounts in euro: distributor/importer organisation registration EUR 500 initial and EUR 500 annual; manufacturer based in Malta EUR 2,500 initial registration with an annual fee banded by headcount from EUR 250 (under 5 employees) to EUR 25,000 (over 150); non EU manufacturer whose authorised representative is based in Malta EUR 2,500 initial and EUR 2,500 annual; authorised representative organisation registration EUR 500 initial and EUR 1,000 annual; initial notification of a device per manufacturer EUR 100 with EUR 15 annual per group; MDRP registration EUR 100 initial and EUR 100 annual; change of organisation details EUR 100; amending a device notification EUR 100; certificate of free sale EUR 250 per declaration of conformity; device registration for the European market EUR 100 per declaration of conformity; derogation applications EUR 1,000 (renewal EUR 750); non CE marked device for use in Malta EUR 500; scientific advice EUR 2,300; search of the national medical devices database EUR 50. All Schedule 5 fees are non refundable.

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.

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.

The published tariff list sets 897 lei per application for approval of type I modifications for medical devices, 1,211 lei per application for approval of type II modifications, and 26,054 lei per dossier for the evaluation of a dossier for authorisation of clinical studies with medical devices.

The domestic manufacturer of medical devices is exempt from registration fees. The exemption is stated both in the law and on AMDM's non CE procedure page.

The tariff for registration and re registration of medical devices is 1,794 lei per application, under the published list of tariffs for the registration of medical devices, of modifications made after registration and of clinical studies with medical devices. The dossier counts as officially filed only on the date the payment is confirmed through the Mpay system, and the tariff paid is not refunded where the dossier is rejected, the examination service having been performed; re filing after remedying the non conformities found is subject to payment of a new tariff.

The AMMPS tariff schedule published by the agency fixes the fee for a medical device registration certificate at 1 000 dirhams TTC, and for an in vitro diagnostic reagent registration certificate at 500 DH. The schedule is validated by the AMMPS Conseil d'Administration and all amounts are expressed in Moroccan dirhams TTC. These are certificate issuance fees, separate from the class III device price and margin regulation and from any additional technical evaluation 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.

The fee payable to the Agency for entry of a medical device in the register is charged per device class following the 2025 amendment of the fees rulebook, which replaced the former per product scale: class I 300 EUR, class II a 400 EUR, class II b 400 EUR and class III 500 EUR; for in vitro diagnostic devices, List A 300 EUR, List B 300 EUR, self testing 200 EUR and all other IVDs 400 EUR. Changes (variations) are charged at 40 per cent of the registration fee, and minor variations notified as part of the technological process at 10 EUR.

Beyond registration, the fees rulebook fixes charges for the other device procedures: 240 EUR for a clinical investigation of a medical device, 240 EUR for an ethics committee opinion and 120 EUR to change a clinical investigation; 1,000 EUR for approval to manufacture medical devices per type, model and place of manufacture, 500 EUR for a partial approval and 100 EUR to change the responsible person; and 1,000 EUR for authorising a body to perform conformity assessment of medical devices.

The fee for a parallel import approval for medical devices remains the per product scale in Article 3(2) of the fees rulebook, which the 2025 per class amendment did not touch: 40 EUR per product for up to 25 products, 24 EUR per product for up to 100 products, and 8 EUR per product for more than 100 products. A variation of a parallel import approval costs 10 EUR where no new approval is needed and 80 EUR where a new approval is required.

Registration of a legal entity in the register of wholesale traders in medical devices costs 471 EUR following the 2026 amendment to the fees rulebook, which cut the fee from the 500 EUR set in 2015. Registration of a specialised shop for retail of medical devices costs 160 EUR.

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.

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.

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.

The DINAVISA 2026 2027 tariff table sets device registration fees in multiples of the jornal mínimo (Gs. 117.077): family registration of class I national 10 jornales (Gs. 1.170.770); class I imported 15 (Gs. 1.756.155); class II imported 20 (Gs. 2.341.540); class III imported 25 (Gs. 2.926.925); class IV imported 30 (Gs. 3.512.310). Class I national renewal is 8 jornales (Gs. 936.616) and class I national modification 5 (Gs. 585.385).

The same 2026 2027 table prices, under ARANCELES PARA DESPACHOS, an import authorisation for registered companies (authorisation to import medical devices) at 2 jornales (Gs. 234.154, code 480 174); and, under ARANCELES PARA PUBLICIDAD, advertising pieces at 2 jornales for written media (480 117), 2 for radio and oral media (480 118) and 3 for audiovisual media, TV and cinema (480 119).

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.

Under the Rwanda FDA tariff regulations (ODDG/RES/TRG/001 Version 5), registration and marketing authorisation of an imported machinery, medical equipment and device is charged at USD 100 where imported from the East African Community, USD 400 where imported from an SRA or WHO Listed Authority, and USD 600 where imported from other sources; the fee covers a five year registration and includes a GMP inspection. A licence for a domestic manufacturing facility for medical equipment and devices is FRW 100,000 and includes the GMP certificate, manufacturing licence and registration/marketing authorisation. Notification of the registration of machinery, medical equipment and devices is fee waived for both domestic and imported products. Annual retention and minor variations are also fee waived. Foreign manufacturer GMP inspections cover up to five production lines at one site, with additional lines charged at USD 400 each.

The pharmaceutical regulation fee decree fixes device homologation fees in CFA francs. For a class D device: registration 1 000 000; renewal 500 000; major variation 1 000 000; minor variation 250 000. For a class C device: registration 500 000; renewal 250 000; major variation 500 000; minor variation 250 000. For class A and B devices, a declaration of medical devices: 10 000, with no deadline. Where the applicant is a local industry, the marketing authorisation is 500 000 for registration, 500 000 for renewal, 250 000 for a major variation and 125 000 for a minor variation. Late renewal carries a penalty of 1% of the renewal amount per day of delay.

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.

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 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.

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.

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.'

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.

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.

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.

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.

statement: Under the Medicines and Allied Substances (Fees) Regulations (S.I. No. 38 of 2016) and ZAMRA's published fee schedule, the application fee for marketing authorisation of an allied substance imported as a finished product is US$500; the annual retention fee is US$200; renewal of marketing authorisation is US$350; evaluation of additional information supplied with an application on inadequate technical information is US$400; a minor amendment is US$100 and a major amendment US$500; and late submission of a renewal application costs US$5 for each day the application is late. For locally manufactured or packaged products the corresponding allied substance fees are payable in Zambian Kwacha: ZMW 1,500 for marketing authorisation, ZMW 1,000 annual retention, ZMW 1,200 renewal, ZMW 400 minor amendment and ZMW 1,950 major amendment. Fast tracking is charged at double the applicable marketing authorisation fee.

statement: The fee for an application for approval of a type and brand of condom is two hundred thousand dollars under the 2005 regulations, and the fee for an application for approval of a type of glove is one hundred thousand dollars under the 2006 regulations (both figures are in the currency of the time, before the 2014 amendments moved the recurring fees to United States dollars). The 2014 amendments inserted a retention fee and a package amendment fee into each instrument's Third Schedule: the fee payable for the retention of the right to sell a type or brand of glove, and of a type or brand of condom, is US$100, payable on or before 1 April annually, and the fee payable for any package amendment is US$50. Testing costs are additional and are borne by the applicant. MCAZ publishes no separate medical device fee schedule: its medical devices fee schedules page carries only the Laboratory Fee Schedule.