On 16 April 2026, a new statutory annual registration fee was added to the medical device fees section 7d1. The fee charged is £300 per Level 2 (or Level 1, where no Level 2 exists) Global Medical Device Nomenclature (GMDN®) Category.…
Amendments have been proposed to the Medical Devices Rules, 2017 which would, among other things, add a new fee schedule for tests and evaluations as the Ninth Schedule to the Rules1. The proposed fees are listed in Table IN1 below.…
The Fees in Respect of Drugs and Medical Devices Order has been amended to specify the new fees for medical device applications that will apply from 1 April 20261. Details of the fees that will apply from 1 April 2026…
Final guidance for industry entitled, Medical Device User Fee Small Business Qualification and Determination, was published on 31 July 20251,2. This guidance updates the previous version of the guidance from 2018, inter alia, to describe how the Food and Drug…
The Food and Drug Administration (FDA) has published the medical device user fees for device submissions and annual fees both for periodic reports and registration of establishments for fiscal year (FY) 2026 (1 October 2025 to 30 September 2026)1. The…
From 1 April 2026, Regulation 53 of the UK Medical Devices Regulations 2002 will introduce a new annual fee and updated fee structure that will apply for the financial year 2026–271,2. The key changes to fees and charges are as…
Implementation of Administrative Order No. 2024-0016, Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration1, had been temporarily suspended for a period of 60 working days to allow the Food and Drug Administration…
The Medical Device (Amendment) Regulations 2025 have been published1 and will come into operation on 1 January 2026. These new Regulations amend the Fifth Schedule to the Medical Device Regulations 2012 to restructure the fees charged for the registration of…
Two Ministerial Decrees of 7 August 2025 – which define the new fee rates for services offered by the Ministry of Health relating to the medical device1 and in vitro diagnostic (IVD)2 sectors – entered into force on 26 September…
Comments were accepted until 31 October 2025 on the proposed fees for 2026 for medical device related activities conducted by the Health Products Regulatory Authority (HPRA)1. A general fee increase of 2.5% has been proposed. It has also been proposed…
From 1 July 2025 to 31 December 2026, the collection of fees in the medical equipment sector will reduce by 50% according to Notification No. 645/TB-HTTB, dated 2 July 20251. Table VN1 lists these reduced fees applicable to medical devices.…
With effect from 16 July 2025, a statutory fee of £261 applies for each registration application submitted to the Medicines and Healthcare products Regulatory Agency (MHRA)1. All medical devices, including in vitro diagnostics, custom-made devices, and systems or procedure packs…
The Medicines and Healthcare products Regulatory Agency (MHRA) has published an updated fee schedule, which took effect on 16 July 20251. Details of the amended fees relating to medical devices are provided in Table UK1 below. Table UK1. Amended…
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its new fee schedule, which took effect on 1 April 20251. Details of the fees relating to medical devices are provided in Table UK1 below. [Table UK1. MHRA fees…
Following a review by the National Audit Office, the Swedish government has given a mandate to the Health and Care Inspectorate (Inspektionen för vård och omsorg, IVO) and the Medical Products Agency (Läkemedelsverket, LV) to investigate the possibility of transferring…
The new price list for services in the field of medicines and medical products performed by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) entered into force on 1 April 20251. The new fees apply to all…
Consultation has been held on proposed amendments to the Therapeutic Goods Administration’s (TGA’s) fees and charges for the 2025–2026 financial year1. The proposal applies the 3.2% indexation factor to all fees and charges in 2025–2026. However, in applying the indexation…
Regulatory authority The Saudi Food and Drug Authority (SFDA) is responsible for the administration of medical device regulation in the Kingdom of Saudi Arabia. It oversees the evaluation, classification, registration and licensing of all medical devices, as well as medicinal…
Administrative Order No. 2024-0016 (9 December 2024) sets out the new schedule of fees and charges for licensing, registration, and other authorisations and regulatory services performed by the Food and Drug Administration1,2. The fees that apply to medical devices and…
A new Decree on the fees charged by the Finnish Medicines Agency (Fimea) has been published1 to replace Ministry of Social Affairs and Health Decree 1282/20232. The new Decree took effect on 1 January 2025 and is expected to remain in…
The Fees in Respect of Drugs and Medical Devices Order has been amended to specify the new fees for medical device applications that will apply from 1 April 20251. Details of the fees that will apply from 1 April 2025…
The guidance for industry and Food and Drug Administration staff concerning Application User Fees for Combination Products has been updated1. This revised document provides guidance on application user fees for combination products as defined under Title 21 of the Code…
The Food and Drug Administration (FDA) has published the medical device user fees for device submissions and annual fees both for periodic reports and registration of establishments for fiscal year (FY) 2025 (1 October 2024 to 30 September 2025)1. The…
Interested parties had until 24 October 2024 to submit comments on proposals to amend the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) statutory fees1. The proposed implementation date for these changes is 1 April 2025. With respect to medical devices,…
Comments were accepted until 30 October 2024 on the proposed fees for 2025 for medical device related activities conducted by the Health Products Regulatory Authority (HPRA)1. A general fee increase of 5% has been proposed. It has also been proposed…
From 1 July 2024, Swissmedic will reduce the fees for processing applications for non-commercially funded clinical trials by 80%1 in an effort to boost Switzerland’s profile as a clinical research location. To qualify for a fee reduction, the sponsor must…
Disposition No. 5634/2024 sets out the new annual fees for the maintenance of a registration in the Register of Medical Technology Producers and Products for both commercialised and non-commercialised products1 (see Table AR1). These fees are approximately three and a…
The new price list for services in the field of medicines and medical products performed by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) entered into force on 9 March 20241. The new fees apply to all…
On 8 February 2024, the standard fee charged for any new registration applications or applications for changes to existing registrations was changed to £240 per application1. All medical devices, including in vitro diagnostics, custom-made devices, and systems or procedure packs…
Consultation has been held on proposed amendments to the Therapeutic Goods Administration’s (TGA’s) fees and charges for the 2024–2025 financial year1. It is proposed that all fees and charges should increase by an inflation-based indexation of 4.7%. There should be…
New fees and charges for services provided by the Ghana Food and Drugs Authority came into effect on 18 March 20241. The registration/re-registration fees for medical devices and medical device reagents are presented in Table GH1. GH1. Registration/re-registration…
Food and Drug Administration Advisory No. 2024-04981 was issued on 6 March 2024 to specify the COVID-19 medicines and medical devices that have been removed from the list of value added tax (VAT) exempt health products, in accordance with Revenue…
A new Decree on the fees charged by the Finnish Medicines Agency (Fimea) has been published1 to replace Ministry of Social Affairs and Health Decree 798/20222. The new Decree took effect on 1 January 2024 and is expected to remain in…
The Fees in Respect of Drugs and Medical Devices Order has been amended to specify the new fees for medical device applications that will apply from 1 April 20241. Details of the fees that will apply from 1 April 2024…
In January 2024, ANMAT Provision 2/20241 modified the fees charged by the National Administration of Drugs, Food and Medical Technology (ANMAT) for the activities it undertakes with respect to medical devices and in vitro diagnostic medical devices (IVDs). A full…
A regular update of the National Institute for Food and Drug Surveillance’s (Invima’s) Tariff Manual1 was carried out on 1 January 2024 and included the following changes: In compliance with the provisions of Article 313 of Law 2294 of…
Interested parties have until 15 March 2024 to comment on a draft schedule of fees and charges for licensing, registration, and other authorisations and regulatory services performed by the Food and Drug Administration (FDA)1,2. The current fees and charges of…
From 1 July 2024, a fee increase averaging 5% will be implemented by the Health Sciences Authority for medical devices and other therapeutic products1. This fee revision is necessary to recover part of the costs for the services rendered to…
Comments were accepted until 27 October 2023 on the proposed fees for 2024 for medical device related activities conducted by the Health Products Regulatory Authority (HPRA)1. A general fee increase of 1.5% has been proposed. It has also been proposed…
Circular No. 44/2023/TT-BTC temporarily reduces the fees due for processing applications in the healthcare sector, including medical devices, until 31 December 20231. This move is designed to assist people and businesses who are struggling because of the current economic climate,…
The Food and Drug Administration (FDA) has published the medical device user fees for device submissions and annual fees both for periodic reports and registration of establishments for fiscal year (FY) 2024 (1 October 2023 to 30 September 2024)1. The…
Regulatory authority State registration is a mandatory procedure necessary for the legal circulation of medical devices in the Republic of Serbia. The following authorities are involved in the approval and marketing of medical devices: Ministry of Health (www.zdravlje.gov.rs) is…
The National Administration of Drugs, Food and Medical Technology (ANMAT) has again amended1 its fees for the activities it undertakes with respect to medical devices and in vitro diagnostic medical devices (IVDs). This is because the fees specified in ANMAT…
Disposition No. 4479/2023 sets out the new annual fees for the maintenance of a registration in the Register of Medical Technology Producers and Products for both commercialised and non-commercialised products1 (see Table AR2). These fees are approximately double the 2022…
Regulatory essentials Regulatory authority Directorate of Medicines and Pharmacy (Direction du Médicament et de la Pharmacie, DMP) Classification system Medical devices: Classes I, Im (measuring), Is (sterile), IIa, IIb, III In vitro diagnostic reagents: None Registration requirements Application form, administrative…
Under certain circumstances, sponsors may apply for a simplified review of a clinical trial authorisation application. Since 1 January 2023, a flat fee of CHF1,500 is charged for this service1. The flat fee for a regular review remains unchanged at…
On 1 April 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) published its new fee schedule for 2023–20241, which generally represents a significant increase from its 2022–2023 fee levels. Details of the fees relating to medical devices are provided…
The Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19)1 introduce amendments to the Medical Devices Regulations to create a permanent regulatory framework for COVID-19…
Consultation has been held on proposed amendments to the Therapeutic Goods Administration’s (TGA’s) fees and charges for the 2023–2024 financial year1. It is proposed that all fees and charges should increase by an inflation-based indexation of 5.2%. There should also…
A new online payment system for the Medical Device Authority called BayarNow became operational on 24 February 20231. This payment system may be used to pay for training fees, product classification letter applications, Certificates of Free Sale and other payments…
