MENA Medical Device Clinical Investigation & Trials: Regulatory Requirements by Country

Clinical Trials Are Becoming Mandatory for High-Risk Devices in MENA

Across the Middle East and North Africa, regulatory authorities are tightening clinical evidence requirements for medical devices. Saudi Arabia's SFDA has evaluated 295 clinical studies for medical devices, approving 157 after they fulfilled all regulatory requirements — with 84 currently active across the Kingdom. Egypt enacted Clinical Trials Law No. 214/2020 and subsequently published comprehensive GCP guidelines. Qatar enacted Law No. 6/2025 on the Regulation of Health Research, which includes provisions for clinical trials involving medical products.

For manufacturers of high-risk devices, innovative technologies, and products without established predicates, conducting clinical investigations in MENA is no longer optional — it is a regulatory requirement. This guide covers the clinical trial frameworks across MENA's major medical device markets as of April 2026.

Saudi Arabia: SFDA Clinical Trial Framework

Regulatory Authority

The Saudi Food and Drug Authority (SFDA) regulates clinical trials of medical devices through MDS-REQ-2 V5 (Requirements for Clinical Trials of Medical Devices), updated in 2025. The framework aligns with the Medical Devices Law (Royal Decree No. M/54) and its Implementing Regulations.

Clinical Trial Landscape

The SFDA has established itself as the region's most active medical device clinical trial regulator:

• 295 clinical studies evaluated to date
• 157 approved after meeting all regulatory requirements
• 84 currently active across various regions of Saudi Arabia
• 33 studies focused on pre-market safety and effectiveness assessment
• 9 clinical studies on innovative medical devices utilizing advanced technologies

When Clinical Trials Are Required

Clinical investigations are mandatory when:

• The device is a novel product without established safety and performance history
• The device is an innovative medical device utilizing advanced technologies (per MDS-G002 Guidance on Innovative Medical Devices)
• Existing clinical evidence from literature or reference markets is insufficient to demonstrate safety and performance
• The SFDA specifically requests clinical data as part of the MDMA review process

Applicable Standards

Clinical trials in Saudi Arabia must comply with:

• Implementing Regulations of the Law of Ethics of Research on Living Creatures
• Declaration of Helsinki
• ISO 14155 — Clinical investigation of medical devices (good clinical practice)
• ISO 20916 — Clinical performance studies of in vitro diagnostic medical devices (for IVD trials)
• MDS-REQ-2 V5 — SFDA-specific clinical trial requirements

Application Process

The SFDA clinical trial application process follows these steps:

1. Obtain SFDA Authorized Representative License — The sponsor must hold a valid AR license
2. Obtain SFDA Establishment License — Required for the entity conducting the trial
3. Submit Clinical Trial Application — Via SFDA electronic system (cloud-based submission; CDs no longer required as of 2025)
4. SFDA Review — The application is reviewed for completeness and compliance
5. Approval or Rejection — SFDA issues an approval letter or rejection letter based on compliance assessment

Required Documentation

• Application form (Annex 1 of MDS-REQ-2)
• Clinical Investigation Plan (CIP) with study design, objectives, and methodology
• Investigator's Brochure
• Informed consent documents (Arabic and English)
• Ethics Committee/IRB approval
• ISO 13485 certificate from the manufacturer
• Device description and intended use
• Risk management file
• Previous clinical data and literature review
• Statistical analysis plan
• Case Report Form (CRF) — version-controlled, as updated in V5
• Manufacturing documentation for the investigational device
• Import authorization (if the investigational device will be imported into KSA)

Key V5 Updates (2025)

The updated MDS-REQ-2 V5 introduced several important changes:

• Version-controlled CRFs are now explicitly required, capturing all protocol-required data with version number and date as approved by the local EC/IRB
• Serious adverse event notification processes and timeframes have been clarified — sponsors must notify the National Center for Medical Devices Reporting within specified time periods
• Trial suspension procedures — new processes and timeframes for suspension of clinical trials
• Cloud-based submission — CDs are no longer required; documents are submitted via SFDA's cloud service
• Arabic-headed letter requirement — list of submitted documents and needed scientific advice must be provided in an Arabic-headed letter

Special Cases

The SFDA has amended the framework for clinical trials in special cases:

• Trials related to national initiatives from the SFDA and related bodies receive priority appointments via the electronic system
• Clinical trials involving innovative medical devices follow additional guidance per MDS-G002, with requirements for documenting all development phases

Safety Reporting Requirements

Sponsors must report:

• SUSAR (Suspected Unexpected Serious Adverse Reactions) — within 15 days; 7 days for fatal or life-threatening cases
• Progress reports — after half the study duration has passed for trials less than one year (changed from quarterly reporting)
• Immediate notification of any event that could seriously affect participant safety

United Arab Emirates: Clinical Investigation Requirements

Regulatory Framework

Clinical trials for medical devices in the UAE are governed by the Emirates Drug Establishment (EDE) and, for specific emirates, by the Dubai Health Authority (DHA) and Department of Health – Abu Dhabi (DOH). The UAE's clinical trial framework has evolved significantly with the establishment of EDE under Federal Decree-Law No. 38 of 2024.

When Clinical Trials Are Required

Clinical investigations may be required when:

• The device is novel or high-risk (Class III/IV) without adequate clinical evidence from reference markets
• The EDE Technical Committee determines that existing clinical data is insufficient
• Devices intended for populations specific to the MENA region may need local clinical evidence

Ethics Committee Approval

All clinical investigations in the UAE require approval from an accredited Ethics Committee (Institutional Review Board). Key requirements:

• The study protocol must be reviewed and approved before enrollment begins
• Informed consent must be obtained in Arabic and English
• The ethics committee must be registered with the relevant health authority

Clinical Trial Registration

Clinical trials conducted in the UAE should be registered with:

• The EDE portal for medical device trials
• The relevant emirate health authority (DHA for Dubai, DOH for Abu Dhabi)
• International registries (ClinicalTrials.gov) are encouraged

MOHAP Clinical Trial Guidelines

The UAE's Ministry of Health and Prevention published Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices, which provides the regulatory framework for interventional clinical trials. Key provisions:

• 90 calendar day review period — MOHAP must notify the applicant within 90 days whether the trial may proceed, requires modification, or is refused
• The Regulatory Committee at MOHAP (RCMOHP) issues permissions for interventional trials, exercises control through annual and safety reporting, and maintains records of all ongoing and completed trials
• Import authorization — Only the sponsor or authorized representative can import investigational products and devices into the UAE
• Ethics committee approval from each participating site is mandatory
• The guidelines apply to both pharmaceutical and medical device clinical trials

Key Considerations

• The UAE's diverse population provides access to varied patient demographics
• Free zone healthcare facilities (e.g., DHCC) may have streamlined ethics approval processes
• Local principal investigators must be licensed by the relevant health authority
• Import of investigational devices requires specific EDE/MOHAP authorization

Egypt: EDA Clinical Trials Framework

Regulatory Authority

Egypt's clinical trial framework is governed by Clinical Trials Law No. 214 of 2020 and its Executive Regulations. The Egyptian Drug Authority (EDA) published a comprehensive Guideline for Good Regulatory Oversight of Clinical Trials that aligns Egypt's framework with ICH E6, WHO GCP, and the Declaration of Helsinki.

Scope

The EDA clinical trial framework applies to interventional clinical research involving:

• Pharmaceuticals
• Biologicals
• Innovative products
• Medical devices
• Herbal medicines

Authorization Pathways

The EDA has established three clinical trial authorization pathways with defined timelines:

Application Process

1. Preclinical Submission — Required for First-in-Human (FIH) trials, including screening, evaluation, and decision timelines
2. Protocol Submission — Complete protocol submitted via EDA Clinical Trial Platform
3. Evaluation — Scientific and ethical review
4. Conditional Approval — May be granted with specific conditions
5. Final Approval — Issued upon meeting all conditions

Amendment Management

The EDA classifies amendments as:

• Substantial amendments — Require EDA approval before implementation, with defined review timelines
• Non-substantial amendments — May be implemented with notification (except to eliminate immediate hazards)

Safety Reporting

Ongoing safety reporting requirements include:

• Adverse Events (AE) and Serious Adverse Events (SAE)
• SUSAR reporting
• DSUR (Development Safety Update Report)
• Periodic progress reports
• Annual renewal of EDA clinical trial approvals

GCP Inspections

The EDA has authority to conduct GCP inspections with the power to:

• Issue findings classified as critical, major, or minor
• Enforce corrective actions
• Suspend or terminate studies for non-compliance
• Inspect investigator sites, sponsors, and CROs

Turkey: TITCK Clinical Trial Framework

Regulatory Authority

The Turkish Medicines and Medical Devices Agency (TITCK) regulates clinical trials under the Regulation on Clinical Trials of Medical Devices, which is aligned with EU clinical investigation requirements. Turkey's framework follows EU MDR principles for medical device clinical evidence.

When Clinical Trials Are Required

Clinical investigations are required when:

• The device does not have adequate clinical evidence from existing literature or equivalent devices
• The conformity assessment requires clinical data beyond bench testing
• The device is high-risk (Class IIb, III) and the Notified Body requests clinical investigation data
• The device is a novel technology without established safety history

Key Requirements

• Clinical investigations must follow ISO 14155 principles
• Ethics committee approval is required before enrollment
• TITCK notification and approval required for clinical investigations conducted in Turkey
• Informed consent must be obtained in Turkish
• The Turkish Authorized Representative plays a key role in managing regulatory communications

EUDAMED Integration

Turkey has an agreement with the European Commission regarding access to EUDAMED, enabling Turkish manufacturers to register devices and supporting cross-border clinical data exchange. This means clinical investigation data generated in Turkey can potentially support EU regulatory submissions.

Israel: MOH Clinical Investigation Requirements

Regulatory Framework

Israel's Ministry of Health (MOH) oversees clinical trials for medical devices. While there is no specific regulation dedicated exclusively to medical device clinical trials separate from the drug framework, the MOH's Medical Devices Division applies medical device-specific requirements within the broader clinical trial legislation.

Clinical Data Requirements

Israel's AMAR relies heavily on clinical data from recognized reference countries (US, EU, Canada, Australia, Japan). Clinical trials conducted within Israel are typically required only when:

• The device has no prior approval in any recognized reference country
• Additional clinical data specific to the Israeli population is needed
• The device is being studied as part of a global clinical investigation program

Key Considerations

• Israel's strong innovation ecosystem means many medical device clinical trials are conducted in Israeli hospitals and research centers
• The IRH (Israel Registration Holder) may assist in coordinating clinical trial activities
• Helsinki Committee (ethics) approval is required for all clinical investigations
• Israel's four health maintenance organizations (sick funds) can facilitate patient recruitment for clinical trials

Qatar: Law No. 6/2025

New Clinical Trials Framework

Qatar enacted Law No. 6 of 2025 on the Regulation of Health Research. While this legislation covers health research broadly, it includes specific provisions for clinical trials involving medical products and novel medical procedures. This represents a significant development for the Gulf state's research governance framework.

Key provisions include:

• Licensing requirements from the Ministry of Public Health for research institutions and clinical trials involving unregistered medical products
• Approval from the National Committee for Health Research Ethics for clinical trials
• Safety reporting obligations for research participants
• Research participant protections including the right to free healthcare related to research participation
• 12-month regularization period for existing research institutions (i.e., by April 2026)

Comparative Clinical Trial Framework Overview

Strategic Recommendations for Multi-Country Trials

1. Design for the Most Stringent Market

If you plan to conduct clinical investigations across multiple MENA countries, design the protocol to meet Saudi SFDA requirements (ISO 14155 compliance, Arabic documentation, version-controlled CRFs). This is the most structured framework and will satisfy requirements in other markets with minimal adaptation.

2. Leverage Reference Market Data

Israel, Saudi Arabia, and the UAE all accept clinical data from FDA and CE-marking investigations. If you already have clinical data from US or EU studies, present this data first and only conduct local trials if the authority specifically requires additional evidence.

3. Engage Local CROs and Investigators

Each country has specific requirements for local investigator licensing, ethics committee registration, and regulatory submissions. Partnering with experienced local CROs dramatically reduces timelines and avoids common pitfalls.

4. Plan for Arabic Documentation

All clinical trial documents (informed consent, patient-facing materials, progress reports) must be available in Arabic for Saudi Arabia, the UAE, and Egypt. Turkish is required for Turkey. Budget for professional medical translation and back-translation.

5. Use Egypt for Cost-Effective Trials

Egypt's large patient population, established GCP framework, and three-tier authorization system (routine/non-routine/reliance) make it an attractive location for generating clinical evidence that can support registrations across the region.

6. Report Early and Often

Saudi Arabia's updated V5 framework emphasizes timely SUSAR reporting (7 days for life-threatening, 15 days for other SUSARs) and mid-study progress reports. Similar requirements exist across all MENA markets. Establishing robust safety reporting systems from the start prevents regulatory actions and trial suspensions.