LexisNexis Middle East

Bahrain: New Regulations On Medical Devices And Products

29/11/202429/11/2024
by Hannah Gutang

The Daily Tribune, 26 November 2024: The Chairman of the Supreme Health Council has announced new regulations aimed at ensuring the quality of medical devices and products in Bahrain.

The decision mandates that all establishments must obtain a licence from the National Health Regulatory Authority (NHRA) to market contact lenses, medical devices, and lasers used for cosmetic purposes.

Under the new regulations, all entities are required to secure a licence from the NHRA, and any activity related to medical devices and products is strictly prohibited unless conducted by a licensed establishment.

This move is intended to strengthen oversight and ensure that only approved products are available in the market.

Furthermore, the regulations stipulate that medical devices and products must only be used in health facilities that hold the appropriate licenses issued by the NHRA.

No device or product may be manufactured, imported, or marketed in Bahrain without prior registration with the NHRA and obtaining written permission for marketing.

The decision outlines that devices and products registered in Bahrain must come from one of the following reference countries: Saudi Arabia (SFDA), the United States (FDA), Australia (TGA), Japan (PMDA), the United Kingdom (MHRA), Ireland (HPRA), Switzerland (Swissmedic), France (ANSM), and Germany (BfArM).

Registration with one of these countries is required, along with payment of the applicable fees.

Establishments are also obligated to store and transport medical devices and products according to the manufacturer’s instructions.

Failure to comply may result in the NHRA revoking the registration of the medical device or the establishment’s licence.

Furthermore, the marketing and advertising of medical devices and products are prohibited without prior authorisation from the NHRA and payment of the required fees.

However, low-risk home medical devices, such as digital thermometers and blood pressure monitors, are exempt from this requirement.

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News developments

Saudi Arabia: To Introduce VAT Refund System for Tourists

28/11/202428/11/2024
by Hannah Gutang

Saudi Arabia will introduce a VAT refund system for tourists in 2025, as outlined in the Saudi Budget statement for the upcoming fiscal year.

The Zakat, Tax, and Customs Authority will oversee the implementation of the system, which is designed to streamline tax compliance and enhance the travel experience.

This initiative underscores Saudi Arabia’s dedication to creating a visitor-friendly environment and attracting more tourists to explore the Kingdom.

As part of its tourism goals, Saudi Arabia aims to attract 127 million visitors by the end of 2025, aligning with the National Tourism Strategy.

The strategy promotes both domestic and international tourism, reinforcing the Kingdom’s position as a global destination of choice.

Tourism spending is projected to reach SR346.6 billion in 2025, contributing significantly to the domestic economy, increasing non-oil revenues, and boosting private sector demand.

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News developments

Lexis Middle East Gulf Tax – Autumn 2024 Edition

27/11/202427/11/2024
by Hannah Gutang

Welcome to the latest edition of Lexis Middle East Gulf Tax Magazine, offering insightful perspectives on the dynamic tax environment in the GCC region. It highlights the continuous development of tax regimes across the GCC, with recent major changes and a greater emphasis on clarifying details through manuals and guidance documents. This issue covers the impact on the charity sector in the UAE, the increase in queries and complaints leading to new legislation, and the evolution of the Zakat regime in Saudi Arabia with significant changes in calculation, entities subject to Zakat, and treatment of cessation of activities.

Furthermore, the article covers the evolution of the Zakat regime in Saudi Arabia, where the Implementing Regulations on Zakat collection from 2019 have been repealed and replaced by new regulations.

Gulf Tax Magazine remains committed to providing valuable knowledge and expert perspectives to help you navigate the complexities of the GCC tax environment. We hope you find this issue insightful and beneficial for your tax planning and compliance efforts.

FEATURE: SO THAT IS ZAKAT

In this feature, Essam Rajab of Andersen explains key changes to the way Zakat is calculated and administered in Saudi Arabia following the issue of new regulations.

FEATURE: GRAPPLING WITH GRIEVANCES

Zain Satardien and Ellen Ray of Hourani & Partners explain the impact a new Ministerial Decision has brought in changes to the way tax grievances are handled in Oman and other recent alterations to the system will have on those disputing the Tax Authority position there.

TAX NEWS ROUND-UP

This round-up covers recent key developments in tax treaties and regulatory changes across the region, providing readers with a comprehensive overview of the latest updates.

WHAT’S CHANGED?

The Federal Tax Authority (FTA) has released an updated list of charities in the UAE that are recognised as ‘Designated Charities,’ allowing them to receive VAT relief. To formalise these updates, the UAE government has issued several Cabinet Decisions.

PRACTICAL FOCUS: PUBLIC BENEFIT ENTITIES

Experts David van der Berg, Gargesh Vn, Tapan Gandhi, and Daryn Blake provided useful information regarding tax exemptions for organisations serving the public good in the United Arab Emirates.

TAX PROFESSIONAL PROFILE

Naveen Sharma, a Chartered Accountant who works as Director of Internal Audit at Oasis Investment Company LLC (Al Shirawi Group), explains his work
and the support he has been giving to the wider tax profession in the UAE.

ANY QUESTIONS?

Rami Alhadhrami of BDO Kuwait analyses
Qatar and Kuwait’s delay in implementing
VAT despite the GCC VAT Agreement.

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Lexis Middle East Gulf Tax_Autumn 2024

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Lexis Middle East Gulf Tax | Summer 2024

Lexis Middle East Gulf Tax | Winter 2023

Lexis Middle East Gulf Tax | Autumn 2023

Lexis Middle East Gulf Tax | Spring 2023

News developments

Lexis Middle East Law Alert: October-November 2024 Edition

27/11/202419/03/2025
by Hannah Gutang

Welcome to the October-November 2024 edition of Lexis Middle East Law Alert, providing insights into the changing legal landscape in the MENA regions. This issue focuses on the GCC countries’ efforts to attract foreign investment and diversify their economies away from hydrocarbons. The publication highlights Saudi Arabia’s new Investment Law, which aims to provide confidence to foreign investors by ensuring fair treatment, protecting ownership rights, and facilitating ease of exit. Additionally, it covers efforts to streamline business establishment processes in Saudi Arabia, as well as developments in the UAE, Bahrain, and the modernisation of Abu Dhabi’s judicial system.

Furthermore, the issue delves into other notable legal developments, including UAE virtual asset marketing regulations, changes to the ADGM Real Property Law, Bahrain’s Domestic Minimum Top-Up Tax, and insights into dispute resolution and contract watch for Saudi labour contracts. The publication serves as a comprehensive resource for staying updated on the latest legal trends and initiatives in the MENA regions, particularly those aimed at fostering a business-friendly environment for foreign investment.

Stay informed with our meticulously curated content, designed to keep you ahead in the ever-changing legal landscape.

FEATURE: EQUALITY AND OPPORTUNITY

Bedoor Alrabiah of GLA & Co explains that Saudi Arabia has a new Investment Law designed to create a more attractive investment environment there by better protecting local and foreign investors’ rights and providing them with more opportunities.

FEATURE: ALL CHANGE

Dhana Pillai, a representative from the Dubai Ports and Trade Corporation (DPTC), sheds light on how Abu Dhabi Law No. 6/2024 is designed to bring about a contemporary transformation of the judicial system in the emirate.

IN-HOUSE PROFILE: TECHNOLOGY’S REGULATORY IMPACT

Hilal Al Khulaifi, Group Chief Legal, Regulatory & Governance Officer, Ooredoo Group explains how dramatic technological change in
the telecoms sector could lead to a regulatory rethink.

DISPUTE RESOLUTION FOCUS

Waleed Hamad and Myriam Simon of Al Aidarous explain how a significant Dubai Court of Cassation ruling has clarified the legal framework surrounding the enforceability of foreign summary judgments in the UAE.

MOVERS AND SHAKERS

A round-up of the most notable appointments and career progressions within the legal field across the region, highlighting the pivotal shifts reshaping the professional landscape.

CONTRACT WATCH: SAUDI LABOUR CONTRACTS

Jassar Aljohani, along with Sara Khoja and Sarit Thomas from Clyde & Co, shed light on the significant amendments to the Saudi Labour Law, which aim to modernise the Saudi labour market, enhance workers’ rights, and streamline employer responsibilities.

Lexis Middle East Law Alert_October-November 2024

Explore the past editions of the Lexis® Middle East Law Alert and stay up-to-date with the latest news! Click the links below for instant access to older editions.

Lexis Middle East Law Alert_January-February 2024

Lexis Middle East Law Alert_May/June 2024

Lexis Middle East Law Alert_August-September 2024

Lexis Middle East Law Alert_July August 2023

TAX AND FINANCE ROUND-UP

Stay updated on the newest tax and financial news across the region, highlighting Bahrain’s recently introduced Domestic Minimum Top Up Tax.

LEGAL ROUND-UP

Stay informed with our legal round-up, providing a comprehensive overview of recent developments across the region with a spotlight on the UAE’s virtual asset marketing regulations.

LAW MONITOR

Delve into the latest legal advancements in the GCC, encompassing modifications to the ADGM Real Property Law.

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News developments

Sharjah: SEDD Implements Executive Council Decision on Registering Family Businesses

27/11/202427/11/2024
by Hannah Gutang

Sharjah Economic Development Department (SEDD) began to implement the Sharjah Executive Council decision regarding the registration of family businesses in the emirate.

This aims to develop the family business system in Sharjah in accordance with the best global practices that go with the provisions of Sharjah Executive Council Decision No. 31/2024 regarding the regulation of family companies in the Emirate of Sharjah.

The SEDD Chairman has stressed that Sharjah is working continuously to develop a legislative and regulatory environment to enhance the growth of family businesses and support their continuity and sustainability over the coming decades, in accordance with the best international practices.

He has added that such thing is important because family businesses represent a basic and significant element in enhancing the growth of the emirate’s economy and supporting its competitiveness regionally and globally.

Also, he has pointed out that in continuation of the national efforts to provide an ideal work environment for family businesses and encourage them to grow and prosper, a number of family businesses have been registered in the Companies Register.

SEDD Director has stated that the decision specified the scope of its provisions to be applied to family companies established in the emirate, existing companies owned by owners from one family, branches of family companies from the emirates, and family companies established in free zones, in a manner that does not conflict with the laws and regulations of the free zones.

According to the decision, the company shall have an incorporation contract in accordance with the provisions mentioned in the Companies Law.

The decision has also included articles regulating the ownership of the family company, the partner’s shares disposition and valuation, the categories of shares, the family endowment company, in addition to the family charter, dispute settlement, dissolution and liquidation of the company, executive decisions, implementation and validity.

Furthermore, the document that regulates the governance of family affairs related to the Family Business, and the family relationship with the family business, in accordance with Sharjah Executive Council Decision No. 31/2024 regarding the regulation of family companies in Sharjah.

This charter includes the rules for family ownership, goals and values, mechanisms for evaluating shares and methods for distributing profits.

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News developments

UAE: Private firms Reminded To Meet Emiratisation Targets By Year End

22/11/202422/11/2024
by Hannah Gutang

Khaleej Times, 19 November 2024: Authorities in the UAE have reminded private sector companies to meet their 2024 Emiratisation targets by the end of December.

Non-compliant firms will face hefty fines starting from 1 January 2025.

Emiratisation policies apply to establishments with 50 or more workers, requiring them to increase the number of Emirati employees in skilled positions by 2% by the end of the year.

Failure to comply will result in a fine of Dh96,000 for each Emirati not hired.

Additionally, a select group of establishments employing 20 to 49 workers across 14 specified economic activities are also subject to Emiratisation policies.

These establishments must employ at least one Emirati and retain any nationals employed prior to 1 January 2024.

Non-compliance will also lead to a Dh96,000 fine for each Emirati not hired.

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News developments

Saudi Arabia: SAMA Issues Rules for Opening Electronic Wallets

22/11/202422/11/2024
by Hannah Gutang

The Saudi Central Bank (SAMA) has issued the final version of “E-Wallet Rules” as part of its supervisory and regulatory role over Electronic Money Institutions (EMIs).

The rules included provisions and obligations related to opening electronic wallets, verification of clients’ identities, and considerations for classifying and managing inactive wallets.

The rules set the relevant regulatory requirements that licensed EMIs must comply with to protect market participants and support EMIs in providing services that increase the sector’s safety and stability.

The SAMA’s decision reflects its continuous efforts to develop the financial sector and empower EMIs.

SAMA had already published the E-Wallet Rules, seeking comments and feedback from the public and experts, to achieve transparency and public participation.

The comments and feedback were studied and taken into consideration in the final version of the rules.

More details of the rules can be had from SAMA’s website at: https://www.sama.gov.sa/en-us/rulesinstructions/pages/regulation.aspx.

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News developments

Sharjah: SCC Discusses Developments of Sharjah Ports Customs and Free Zones Authority

22/11/202422/11/2024
by Hannah Gutang

The Sharjah Consultative Council (SCC) continued its third session of the second ordinary meeting in its eleventh legislative term to discuss the policies of the Sharjah Ports, Customs, and Free Zones Authority (SPCFZA).

A Member of Sharjah’s Executive Council and Chairman of SPCFZA has highlighted the authority’s role in supporting the tourism and commercial sectors, aligning its strategies with federal and local visions.

He has emphasised initiatives like digitising services and using AI to streamline operations, enhance sustainability, and foster community engagement.

Members have raised concerns on emiratising jobs in free zones, boosting customs efficiency, and developing specialised zones for food security.

Proposals included leveraging technology like AI for customs processes, promoting sustainable energy in free zones, and enhancing partnerships with educational institutions to align academic outcomes with market needs.

The session concluded with the SPCFZA reiterating its commitment to advancing Sharjah’s investment environment and supporting the national economy through modern infrastructure and digital transformation.

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News developments

Qatar: Shura Discusses Draft Law to Regulate Travel and Air Freight Offices

22/11/202422/11/2024
by Hannah Gutang

Qatar Tribune, 19 November 2024: During the session, the council had discussed a draft law to regulate travel and air freight offices, which was referred to the Health, General Services and the Environment Committee for further review and submission of a report.

Additionally, the council endorsed a bill amending some provisions of Qatar Law No. 15/2011 , on combating human trafficking, following the review of the report by the Committee on Internal and External Affairs and discussion of the provisions of the draft law by the esteemed members.

The council has also discussed reports on the participation of its delegations in several regional and international parliamentary events.

The meeting focused on strengthening Gulf unity, enhancing joint parliamentary action, and serving the interests of GCC states and their citizens.

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News developments

Oman: Health Ministry Launches Health Institutions Accreditation System

22/11/202422/11/2024
by Hannah Gutang

Times of Oman, 17 November 2024: The Health Ministry has marked the launch of the Omani System for Accreditation of Health Institutions (OSAHI), which will be applied to all government, civil, military and private health institutions.

OSAHI, recognised by the International Society for Quality in Health Care (ISQua), aims to develop healthcare service procedures and improve quality.

The new system seeks to help health institutions in Oman meet their obligations by upgrading the quality of healthcare.

The system was established to be compatible with local reality, aligned with international regulations for the next stage of domestic growth.

Besides catering to the needs of patients, the system also ensures the safety of healthcare workers.

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