Since 1 May 2021, the fees and charges set out in Table 3 apply to medical equipment1, in accordance with Article 76, Item 2 of the Medical Device Management Law and Article 10 of the Fees Law. Table 3.…
Public consultation was held in May 2021 on a proposal for The Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 20211. These Regulations would apply to fees for regulatory activities for non-regulated and regulated products to include medicines, medical…
Consultation has been held on proposed amendments to the Therapeutic Goods Administration’s (TGA’s) fees and charges for the 2021–2022 financial year1. Three options for the annual change to fees and charges were proposed, including no increases and a percentage increase…
Taiwan’s new Medical Devices Act1, which formally separates the regulation of medical devices from pharmaceuticals, is set to take effect on 1 May 2021. The Act defines medical devices as: ‘instruments, machines, apparatus, materials, software, reagents for in vitro…
Regulatory authority The Ministry of Health and Prevention (MoHAP) is responsible for the administration of medical device regulation in the United Arab Emirates (UAE). The Ministry oversees evaluation, classification, registration, and licensing of all medical devices, including in vitro diagnostic…
On 22 December 2020, the South African Health Products Regulatory Authority (SAHPRA) published a list of new fees payable to them1. The fees that affect the medical device industry (Section 4) are as follows: new licence application fees: manufacture =…
In a recent announcement1, the Saudi Food and Drug Authority has clarified the reduced and administrative fees that apply to applications for various updates to an existing Medical Device Marketing Authorization (MDMA): addition of a device(s) = 5000 SAR…
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 20211. Most fees in the Order are being phased in over four…
Council Directive (EU) 2020/2020 was published on 11 December 2020 to amend Directive 2006/112/EC and introduce temporary measures for value added tax (VAT) applicable to COVID-19 vaccines and in vitro diagnostic medical devices (IVDs) in response to the COVID-19 pandemic1.…
Regulatory authority The regulatory system for healthcare in the Republic of Peru is not segmented; there is a single national authority for pharmaceutical products and medical devices, including in vitro diagnostic medical devices (IVDs). That authority is the General Direction…
Comments have been solicited on the medical device fees for 2021 proposed by the Health Products Regulatory Authority (HPRA)1. Although the HPRA expects 2021 to be a challenging year, the cost savings made in 2020 mean that a general fee…
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) 2021 (1 October 2020 to 30 September 2021)1. The…
The Drugs Controller General of India has confirmed that no fee is payable for changing the address of an Authorised Agent post-approval as long as there is no change in constitution1. Post-approval changes are set out in the Sixth Schedule…
A period of public consultation has been held on proposed amendments1 to the Enforcement Rule of the Medical Devices Act. The changes, proposed by the Ministry of Food and Drug Safety, would increase the fees for medical device licences and…
New administrative fees and charges for medical equipment have been drafted by the Taiwan Food and Drug Administration1. As the number of applications for medical equipment inspection registrations continues to grow and is innovative and progressive, it requires a lot…
Circular 64/2020/TT-BTC temporarily reduces the fees due for processing applications in the medical sector, including medical devices, until 31 December 20201. This move is designed to assist businesses who are struggling because of the COVID-19 pandemic, while ensuring social welfare…
On 1 July 2020, revised fees and charges for medical device and in vitro diagnostic activities became applicable in Australia for the 2020–2021 financial year. Full details are available on the Therapeutic Goods Administration (TGA) website1. Additionally, a 50% reduction…
The fees that are being charged by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for 2020/2021 are remaining the same as for 2019/20201. These fees include the issuance of medical device export certificates, clinical investigations for medical devices,…
Since 1 April 2020, fees for medical devices are charged as per the Fees in Respect of Drugs and Medical Devices Order (see Table 1)1. Medical device licence application fees only apply to Class II, III and IV medical device…
A new schedule of fees and charges for the services rendered by the Food and Drug Administration (FDA), along with guidelines for its implementation in 2020, has been proposed1. When finalised, the new schedule will repeal Administrative Order No 50…
Regulatory authority The Central Administration of Pharmaceutical Affairs (CAPA) within the Egyptian Drug Authority (EDA) is responsible for overseeing the regulation of medical devices in Egypt. CAPA has overall responsibility for the evaluation, classification, registration and licensing of locally produced…
On 1 January 2020, control of health technology and other related activities transferred1 from Valvira (a national agency operating under the Ministry of Social Affairs and Health, charged with the supervision of the social and health care, alcohol and environmental…
On 20 December 2019, President Donald Trump signed Bill HR 1865, the Further Consolidated Appropriations Act, 2020, which became Public Law No 116-941. Among its numerous provisions, this law repeals the controversial medical device excise tax for sales made after…
Industry and other stakeholders are being provided with an opportunity to comment on options for the Therapeutic Goods Administration’s (TGA’s) proposed fees and charges for the 2020–2021 financial year1. The TGA’s preferred option is to increase all fees and charges…
New Medical Device Marketing Authorisation (MDMA) fees were set to take effect in Saudi Arabia on 1 December 2019 (04/04/1441 H)1. However, an announcement in December 20192 has postponed the implementation date of these new fees until further notice. …
New Medical Device Marketing Authorisation (MDMA) fees are set to take effect in Saudi Arabia on 1 December 2019 (04/04/1441 H)1. The new fee structure is based on the number of products in an application and not on the risk…
On 1 July 2019, a new schedule of fees payable under the Medicines Act 1981 came into effect1. The new fee for a medical device Regulatory Statement to Foreign Government (per statement) is NZ$178.25. Reference 1. https://www.medsafe.govt.nz/regulatory/Fees/New%20Fees.pdf
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) 2020 (1 October 2019 to 30 September 2020)1. The…
The Health Products Regulatory Authority of Ireland (HPRA) has proposed a general fee increase of 3% for the 2020 financial year plus other the specific changes, citing increased workloads and staffing costs, as well as the challenges posed by Brexit,…
On 1 July 2019, revised fees and charges for medical device and in vitro diagnostic activities became applicable in Australia for the 2019–2020 financial year. Full details are available on the Therapeutic Goods Administration website1. Reference 1. https://www.tga.gov.au/schedule-fees-and-charges
Canada’s 2017 budget granted the Minister of Health new fee setting authorities that give the flexibility to set and adjust fees in a timely way so that they better reflect actual costs and allow Health Canada to deliver more effectively…
Registration, inspection and other related fees for regulatory activities conducted by the Pharmaceutical and Medical Devices Agency (PMDA) were increased with effect from 1 April 2019. The full fee structure (in Japanese) has been posted on the PMDA website1. …
On 1 April 2019, 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…
Comments are being solicited until 8 February 2019 on the Therapeutic Goods Administration’s (TGA’s) proposed changes in fees and charges for 2019–20201. After extensive consultation with industry representative groups, the preferred option is to increase all fees and charges by…
Singapore’s Health Sciences Authority (HSA) intends to increase the fees it charges for health product regulatory activities, including medical devices, by an average of 3%1. The fee increases are set to take effect on 2 April 2019. The majority of…
A Guidance Document for Medical Devices has been drafted1 by the Indian Pharmacopoeia Commission (IPC) to act as a consolidated reference document describing the standards, regulatory and other requirements for medical devices in India. Topics addressed by the draft guidance…
On 12 October 2018, the Therapeutic Goods Administration’s summary of fees and charges was updated to include a change in the application fee for export only medical devices1. The revised document states that the application fee for inclusion in the…
The Food and Drug Administration has published the medical device user fees for medical device submissions and annual fees both for periodic reports and registration of establishments for Fiscal Year (FY) 20191. The fees, which took effect on 1 October…
The fees that are being charged by the UK Medicines and Healthcare products Regulatory Agency for 2018/2019 are remaining the same as for 2017/20181. These fees include the issuance of medical device export certificates, clinical investigations for medical devices, and…
The Agency for Medicinal Products and Medical Devices of Serbia (ALIMS) has issued a notice to holders of medical device registrations listed in the Register of Medical Devices to clarify the correct payment of fees (amount and timing) for its…
Regulatory authority The Competent Authority for medical devices in Zimbabwe is the Medicines Control Authority of Zimbabwe (MCAZ). This Agency is responsible for, inter alia, control and assessment of the quality of medical devices, and issuing registrations and distributor registration…
A period of public consultation has been held on a new schedule of fees and charges from the Food and Drug Administration for licensing, registration, and other authorisations and regulatory services1,2. The proposed fees that relate specifically to medical devices…
On 1 July 2018, an application fee of Aus$530 was introduced for a Class I medical device entry on the Australian Register of Therapeutic Goods (ARTG)1. To help sponsors optimise their ARTG listings so that they only pay fees where…
On 1 July 2018, revised fees and charges for medical device and in vitro diagnostic activities became applicable in Australia for the 2018–2019 financial year. Full details are available on the Therapeutic Goods Administration website1. Reference https://www.tga.gov.au/schedule-fees-and-charges
A public consultation on the 2018 medical devices fees proposed by the Health Products Regulatory Authority of Ireland (HPRA) ended on 25 May 20181. Based on the comments received in respect of the 2017 fees, the 2018 proposal better aligns…
Introduction The regulatory requirements for market placement of medical devices in the Russian Federation are in a state of transition from the country’s domestic legislation to the rules of the Eurasian Economic Union (EEU). At present the two regulatory systems…
China has reduced the import tariffs on 201 technology products, including around 30 medical device types1, under an amendment to the World Trade Organisation’s Information Technology Agreement, which was ratified by China in September 2016. Affected medical devices include electrodiagnostic…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has proposed increasing its fees significantly from April 2017 in order to collect an additional £221,000 annually1. The current fees charged by the MHRA do not recover fully the costs of…
Regulatory authority Article 3 of the Pharmaceutical Affairs Act (PAA)1 authorised the establishment of the Taiwan Food and Drug Administration (TFDA) in 2010 within the Ministry of Health and Welfare (MoHW) to administer ‘medicaments’. According to Article 4 of the…
On 1 July 2017, revised fees and charges for medical device and in vitro diagnostic activities became applicable in Australia for the 2017–2018 financial year. Full details are available on the Therapeutic Goods Administration website1. Reference https://www.tga.gov.au/schedule-fees-and-charges
