Overview of Mexico Mexico is a country with more than 125 million inhabitants and a wide diversity of medical conditions, most of them chronic and degenerative, such as cardiovascular disease, diabetes and cancer. To understand the Mexican market for medical…
Descripción general del país México es un país con más de 125 millones de habitantes, con una gran diversidad de padecimientos, la mayoría crónico degenerativos, como son las enfermedades cardiovasculares, diabetes, cáncer, entre otros. Para entender el mercado de los…
MDCG 2023-2 provides templates1 for Notified Bodies to use to list their standard fees for conformity assessment activities under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Article 50 of…
On 1 January 2023, the Medicines Evaluation Board (MEB) increased its fees for consultation procedures involving medical devices as the costs associated with these activities deviate significantly from their revenue1. A new fee has also been introduced for major changes…
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 20231. Most fees in the Order are being phased in over four…
Certain changes have been made to the annual licence review (ALR) package for 20231. A fees checklist has been incorporated into the ALR summary report. Information relating to fees and small business status should be included in the email instead…
The Food and Drug Administration is seeking public comment on advancing Real-World Data and Real-World Evidence (RWE) with user fee funding1. A public docket (FDA-2023-N-0156) has been opened for stakeholders to provide specific comments on how the Agency should use…
In January 2023, ANMAT Provision 10114/20221 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 period of public consultation has been held on the following three proposals: Draft amendment of the Charge Standards of Administrative Fees for Medical Devices1: addition of a fee of NT$30,000 for Good Distribution System inspection or its follow-up…
The Finnish Medicines Agency’s new fee regulation – Ministry of Social Affairs and Health Decree 798/2022 – has introduced changes to the fees charged for medical devices1. The Decree entered into force on 1 September 2022 and is expected to…
Comments were solicited until 29 October 2022 on the annual review and proposal for fees for 20231. The Health Products Regulatory Authority (HPRA) has proposed a general fee increase of 9% for 2023. However, as medical device fees increased overall…
Applications for marketing authorisation or amendment of marketing authorisation, evaluation of a biocidal active ingredient, and issuance of Certificates of Free Sale must be accompanied by a statement of payment of the relevant fee (as set out in the Ministerial…
New fees for medical devices have been published in the Journal of Laws (item 1582) and came into effect on 29 July 20221. These fees are as follows: for submitting an application to issue a Certificate of Free Sale…
Interested parties have until 11.45pm on 23 November 2022 to submit comments on the 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 2023. The proposed…
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) 2023 (1 October 2022 to 30 September 2023)1. The…
Ministerial Resolution No. 507 of 20221 specifies the fees that will be charged by the Central Administration of Medical Devices for its examination and re‑examination of diagnostic and laboratory reagent files submitted to the Administration to allow circulation in the…
Regulatory authority The Ministry of Health, Drug and Food Control (MoH), through its Pharmaceutical and Herbal Medicines Control and Registration Administration, is responsible for medical device regulation in Kuwait. It oversees the evaluation, classification, registration and licensing of all medical…
Disposition No. 4365/2022 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). Table AR1. Annual maintenance fees (in…
The National Directorate of Medicines (DNM) has informed1 users of the Medical Devices Registration Unit that the fees for requests for certificates and certifications are as follows: proof of registration: US$10; certificate of registration (per product): US$10; proof of…
On 1 July 2022, revised fees and charges for medical device and in vitro diagnostic activities became applicable in Australia for the 2022–2023 financial year. Full details are available on the Therapeutic Goods Administration (TGA) website1. Reference 1. https://www.tga.gov.au/sites/default/files/fees-and-charges-summary-1-july-2022.pdf
The Central Administration of Medical Supplies has announced the fees charged for services relating to the re-registration of medical supplies after the lapse of the specified re-registration periods1: Application to re-register a medical device in the first three months…
In June 2022, MDA/GL/08, Guideline for re-registration of registered medical device, was published by the Medical Device Authority1. This guidance provides information and clarification to establishments on submitting re-registration (renewal) applications for registered medical devices. Medical device registrations are valid…
An updated schedule of fees payable under the Medicines Act 1981 became effective on 1 July 20221. A Regulatory Statement to Foreign Government for a medical device now costs NZ$186 per statement. Reference 1. https://www.medsafe.govt.nz/regulatory/FeesScheduleJuly2022.pdf
The Central Administration of Medical Supplies has published1 a schedule of fees for the services of issuing an annual import approval for a set of (finished) in vitro diagnostic reagents (see Table EG1). Table EG1. Fees for issuing an…
Consultation has been held on proposed amendments to the Therapeutic Goods Administration’s (TGA’s) fees and charges for the 2022–2023 financial year1. Three options for the annual change to fees and charges have been proposed, including no increases and a percentage…
In March 2022, ANMAT Provision 1641/20221 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) including: …
On 28 March 2022, the Food and Drug Administration (FDA) announced it is requesting a total budget of US$8.4 billion as part of the President’s fiscal year (FY) 2023 budget, which is almost 34% higher than the Agency’s FY 2022…
With effect from 1 April 2017, a number of central administrative fees have been cancelled or suspended in China1, including the fees charged by China Food and Drug Administration (CFDA) testing centres for medical equipment and drug inspections (type testing),…
On 9 February 2017, an Interministerial Ordinance from the Ministries of Finance and Health (45/2017)1 formally revoked the high fee increases for medical device and in vitro diagnostic (IVD) related activities, including registration and Good Manufacturing Practice certification, introduced in…
On 16 March 2017, the Trump Administration unveiled its blueprint for the 2018 budget1. This budget proposal indicates that the Food and Drug Administration (FDA) will need to collect over US$2 billion in 2018 from medical product user fees, approximately US$1…
On 1 April 2017, Health Canada’s revised fee structure came into effect1. In line with Section 4 of the 2011 Fees in Respect of Drugs and Medical Devices Regulations, every fee outlined by the Regulations must be increased annually by…
On 1 April 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) increased its fees significantly through publication of The Medical Devices (Fees Amendment) Regulations 2017 (Statutory Instrument 2017/207)1. The previous fees charged by the MHRA did not recover…
The idea of a common Eurasian medical device market The Eurasian Economic Union (EAEU) comprises Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan and has a combined population of more than 184 million. In its first five years, the gross domestic product…
Introduction The VietNamese healthcare market is in a time of change as the government seeks to invest in aging facilities and equipment while enticing foreign manufacturers with new, friendlier regulations. Seen as a high potential market, only specific medical devices…
A Commission Implementing Regulation has been drafted to set out the detailed rules for the application of Article 100 of Regulation (EU) 2017/746 (IVDR) with respect to the tasks of, and criteria for, European Union Reference Laboratories (EURLs) in the…
The State Institute for Drug Control has updated its tariff of fees and services with effect from 1 January 20221. This new tariff reflects rising operating and labour costs, removes some out of date items and adds new items. The fees…
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 20221. Most fees in the Order are being phased in over four…
If an applicant needs to pay a fee for a medical device or in vitro diagnostic reagent registration application, the applicant must now pay that fee within 15 working days after acceptance of the application, otherwise the application will be…
From 1 July 2022, a fee increase averaging 3% 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…
Introduction À une certaine époque, il existait un monopole d’État sur toutes les activités économiques en Algérie, y compris celles relatives aux produits pharmaceutiques et aux dispositifs médicaux. La médecine gratuite a été instaurée en 19741 et la loi santé…
Introduction The medical device industry has been largely unregulated in South Africa with the first medical device regulations introduced in 20161. As such, South Africa is still within the early stages of developing and implementing medical device regulations. The South…
Introduction At one time, there had been a State monopoly on all economic activities in Algeria, including those relating to pharmaceutical products and medical devices. Free healthcare was first introduced in 19741 and the 2018 Health Law continues this through…
Comments were solicited until 29 October 2021 on the annual review and proposal for fees for 20221. The Health Products Regulatory Authority has proposed a general fee freeze for 2022, subject to some amendments arising from submissions or changing circumstances…
The State Institute for Drug Control has expanded the scope of its eVAR system – electronic assignment of a variable symbol (for identifying a transaction) and monitoring of payment – to speed up and streamline processes in the field of…
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) 2022 (1 October 2021 to 30 September 2022)1. The…
Food and Drug Administration (FDA) Circular No. 2021-019 sets out updated guidelines1 for the payment of applications to the Radiation Regulation Division (RRD) of the Center for Device Regulation, Radiation Health, and Research (CDRRHR), repealing FDA Circular No. 2018-004. The…
Introduction As the standard of living continues to rise in Thailand and around the world, people continue to demand better healthcare. Better healthcare can come in many forms, from early detection diagnostics utilising artificial intelligence to wearable technology. Heavily relying…
The Ministry of Social Affairs and Health has issued a new payment Regulation to specify the updated fees payable for the regulatory activities undertaken by Fimea, the Finnish Medicines Agency1. This new payment Regulation (437/2021) replaces the old Regulation (1499/2019)…
Disposition No. 4530/2021 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 1). Table 1. Annual maintenance fees (in…
On 1 July 2021, revised fees and charges for medical device and in vitro diagnostic activities became applicable in Australia for the 2021–2022 financial year. Full details are available on the Therapeutic Goods Administration (TGA) website1. Reference 1. https://www.tga.gov.au/publication/fees-and-charges-summary-1-july-2021
