MENA IVD & Diagnostics Registration: Country-by-Country Requirements
Complete guide to in vitro diagnostic (IVD) registration across MENA — Saudi SFDA IVD classification (A–D) and companion diagnostic guidance, UAE EDE IVD requirements and fees, Egypt EDA IVD classes with ISO 15189/CLSI performance evaluation, Turkey TITCK IVDR-aligned framework, Israel AMAR IVD declaration route, and point-of-care testing requirements.
The MENA IVD Market Is Growing Faster Than Any Other Device Segment
The Middle East and Africa in vitro diagnostics market was valued at $3.33 billion in 2025 and is projected to reach $4.42 billion by 2031, growing at a 4.8% CAGR according to MarketsandMarkets (April 2026). The Middle East IVD market alone — excluding Africa — was estimated at $2.17 billion in 2025 and is expanding at 7.25% CAGR to reach $3.80 billion by 2033 (Grand View Research). Saudi Arabia holds the largest share, with its IVD market set to reach $1.06 billion by 2033 at a 3.8% CAGR.
These numbers reflect a fundamental shift: governments across MENA are investing in laboratory modernization, expanding diagnostic testing capacity, and adopting point-of-care testing at unprecedented rates. Yet IVD registration remains a country-by-country process with distinct classification systems, documentation requirements, and regulatory timelines. This guide covers the complete IVD registration requirements for each major MENA market as of April 2026.
Saudi Arabia: SFDA IVD Framework
Regulatory Authority
The Saudi Food and Drug Authority (SFDA) regulates IVDs through its Medical Devices Sector, applying the same Medical Devices Marketing Authorization (MDMA) framework used for conventional medical devices. IVDs are classified under the SFDA's GHTF-aligned risk-based system.
IVD Classification System
The SFDA classifies IVDs into four risk categories:
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low individual and public health risk | General laboratory reagents, specimen collection devices, instruments not intended for specific diagnostic use |
| Class B | Moderate individual risk, low public health risk | Self-testing pregnancy tests, blood glucose meters, clinical chemistry reagents, urine dipsticks |
| Class C | High individual risk, moderate public health risk | Blood typing reagents, infectious disease screening tests (non-bloodborne), genetic testing kits, tumor marker assays |
| Class D | High individual and public health risk | Bloodborne pathogen screening (HIV, HBV, HCV), blood grouping reagents, companion diagnostics |
Registration Pathway
IVDs follow the same MDMA process as conventional devices:
- Class A IVDs — Registration via listing only. No full technical review required. The applicant submits basic product information and the SFDA issues a listing certificate.
- Class B, C, D IVDs — Full MDMA application required, including technical documentation review, conformity assessment, and clinical/performance evaluation data.
Companion Diagnostic Guidance (March 2025)
In March 2025, the SFDA published dedicated guidance on companion diagnostic (CDx) IVDs (MDS-G026). Key requirements:
- CDx IVDs must demonstrate clinical performance through studies conducted per Annex 7 of MDS-REQ1
- Clinical performance studies conducted within Saudi Arabia must comply with MDS-REQ2 (Requirements for Clinical Trials of Medical Devices) and receive formal SFDA Medical Devices Sector approval
- The guidance applies to local CDx manufacturers, authorized representatives of foreign manufacturers, and healthcare institutions developing in-house CDx assays
- CDx devices require coordination between the drug regulatory pathway and the device MDMA process
Required Documentation
- IVD classification justification per SFDA rules
- ISO 13485 certificate from the manufacturer
- CE certificate under EU IVDR or FDA clearance (if available)
- Performance evaluation report
- Clinical evidence or clinical performance study data (for Class C/D)
- Risk management file (ISO 14971)
- Labels and IFU in Arabic and English
- Letter of Authorization to the Local Authorized Representative (LAR), legalized
- Certificate of Free Sale from country of origin
Fees and Timeline
| Item | Details |
|---|---|
| MDMA application fee (Class B) | Approximately SAR 19,000 ($5,060) |
| MDMA application fee (Class C) | Approximately SAR 21,000 ($5,600) |
| MDMA application fee (Class D) | Approximately SAR 23,000 ($6,130) |
| Review timeline | 35 working days for MDMA review |
| Registration validity | 3 years (renewable) |
| Authorized Representative | LAR mandatory for all foreign manufacturers |
IVD vs. General Laboratory Products
The SFDA distinguishes between IVDs and general laboratory products (GLU). Products labeled "For General Laboratory Use" and "Not for medical use or for use in diagnostic procedures" are not regulated as IVDs. However, when a general laboratory product is labeled or promoted for a specific medical use, it becomes an IVD regulated by the SFDA. Examples of GLU products include centrifuges, scales, balances, and autoclaves not intended for diagnostic purposes.
United Arab Emirates: EDE IVD Framework
Regulatory Authority
The Emirates Drug Establishment (EDE) manages IVD registration under the framework established by Federal Decree-Law No. 38 of 2024, which replaced MOHAP as the central medical device regulator effective January 2025.
IVD Classification System
The UAE classifies IVDs into four risk tiers:
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low risk | Specimen receptacles, stains for microscopic use, instruments not intended for specific IVD use |
| Class B | Low to moderate risk | Self-testing devices for non-critical parameters, vitamins and enzyme assays |
| Class C | Moderate to high risk | Self-testing blood glucose devices, infectious disease tests, cancer screening assays |
| Class D | High risk | Blood grouping reagents, bloodborne pathogen screening, companion diagnostics |
Registration Process
IVD registration follows the standard EDE medical device registration process:
- Manufacturer Site Registration — The manufacturing facility must be registered with EDE first (4–8 weeks, AED 10,100 registration fee)
- IVD Classification — If uncertain, request a formal classification decision from EDE (AED 500 fee, 2–4 weeks)
- Dossier Preparation — Compile technical documentation including performance evaluation data, CE certificate or FDA clearance, ISO 13485, labels and IFU (Arabic and English)
- Submission via EDE Portal — The Local Authorized Representative submits the dossier through the EDE e-portal using UAE PASS authentication
- Technical Committee Review — The committee evaluates safety, performance, and compliance (45 working days for standard review)
- Registration Certificate Issued — Valid for 5 years
Fees
| Service | Fee (AED) |
|---|---|
| Application fee | 100 AED ($27) |
| IVD registration | 5,000 AED ($1,362) |
| Classification letter | 500 AED ($136) |
| Manufacturer registration | 10,100 AED ($2,748) |
| Renewal (5 years) | 2,500 AED ($681) |
Key Considerations
- All foreign manufacturers must appoint a Local Authorized Representative (LAR) in the UAE
- IVD performance evaluation data should be aligned with international standards
- Higher-risk IVDs (Class C/D) may require clinical data, safety reports, and Free Sale Certificates
- Dubai Health Authority (DHA) and Department of Health – Abu Dhabi (DOH) maintain parallel oversight for procurement within their respective emirates
Egypt: EDA IVD Framework
Regulatory Authority
The Egyptian Drug Authority (EDA), through its Central Administration of Medical Devices, regulates IVDs under the country's evolving medical device framework. In February 2026, the EDA introduced facilitation measures to streamline registration procedures while maintaining safety standards.
IVD Classification System
Egypt has adopted the EU MDR/IVDR-aligned classification system:
| Class | Risk Level | Registration Pathway |
|---|---|---|
| Class A | Low risk | Listing with importation record |
| Class B | Low to moderate risk | Full registration required |
| Class C | Moderate to high risk | Full registration with performance evaluation |
| Class D | High risk | Full registration with detailed clinical performance data |
Registration Requirements
IVD registration in Egypt requires:
- Appointment of an Egyptian Registration Holder (ERH) for foreign manufacturers
- Performance evaluation data aligned with ISO 15189 and/or CLSI guidelines
- CSDT (Common Submission Dossier Template) format or EU MDR/US FDA-based dossier with clear mapping
- CE certificate or FDA clearance (recommended, not always mandatory)
- ISO 13485 certificate
- Labels and IFU in Arabic and English
- Manufacturer's commitment regarding safety of IVDs (declaration form)
- Pilot batch production for local manufacturers without international quality certificates
Fees and Timeline
| Item | Details |
|---|---|
| Regular track fee | ~$450/device |
| Fast-track fee | ~$1,280/device |
| Review timeline | 6–8 months (simplified measures effective Feb 2026) |
| IVD registration validity | 5 years |
| Medical device validity | 10 years |
February 2026 Simplification Measures
The EDA's February 2026 facilitation measures include:
- Relationship letters between company branches accepted via official authenticated email (no prior legalization required at submission)
- Free Sale Certificates accepted without the previous 3-month validity requirement
- Commitment letters to submit legalized documents within a specified timeframe are accepted
Local Manufacturing
Egypt's EDA has specific provisions for locally manufactured IVDs:
- Pilot batch production required for facilities without international quality certificates
- EDA laboratory analysis must be completed within 30 working days
- Factory technical report required after 40 working days grace period
- Registration file must be submitted within one year of receiving EDA response
Turkey: TITCK IVDR-Aligned Framework
Regulatory Authority
The Turkish Medicines and Medical Devices Agency (TITCK) regulates IVDs under the Regulation on Medical Devices for In Vitro Diagnostic Purposes, which is harmonized with the EU IVDR (Regulation 2017/746). Turkey maintains full alignment with EU legislation so that devices lawfully marketed in Turkey can circulate freely within the EU/EEA and vice versa.
IVD Classification System
Turkey applies the EU IVDR classification (A–D) directly:
| Class | Risk Level | Conformity Assessment |
|---|---|---|
| Class A | Low risk | Self-declaration of conformity by manufacturer |
| Class B | Moderate risk | Notified Body assessment required |
| Class C | High individual risk | Notified Body assessment required |
| Class D | High public health risk | Notified Body assessment with additional scrutiny |
Registration Process
- CE Marking — IVDs must have valid CE marking under the IVDR
- ÜTS Registration — All IVDs must be registered in the Product Tracking System (Ürün Takip Sistemi) before marketing
- Turkish Authorized Representative — Non-Turkish manufacturers must appoint a Turkey-based Authorized Representative
- Documentation Submission — Technical dossier submitted via ÜTS, including EC certificate, ISO 13485, technical file, and Declaration of Conformity
- TITCK Review — Assessment of compliance with Turkish regulations
Key Requirements
- Documentation, labeling, and IFU must be provided in Turkish
- CE marking alone does not automatically grant Turkish market access — ÜTS registration is mandatory
- Registration is valid indefinitely (renewal only required for significant product changes or certificate renewal)
- TITCK maintains access to EUDAMED under an agreement with the European Commission
- Class I devices can be registered in a few weeks; higher classes may take up to six months
TITCK Exclusion List (2026)
TITCK's 2026 exclusion list clarifies products that are not IVDs:
- Dual-use laboratory equipment used for both medical and non-medical purposes (depending on intended use)
- General laboratory products without specific medical claims
- Devices for non-medical purposes (e.g., paternity tests, drug abuse detection without medical intent)
Israel: AMAR IVD Registration
Regulatory Authority
Israel's Medical Devices Division, operating under the Ministry of Health (AMAR), regulates IVDs using the same tiered registration system as conventional medical devices. AMAR recognizes IVDR classification (A–D) for IVD devices.
IVD Registration Routes
IVDs follow the same route structure as medical devices, based on risk level and prior approval in recognized reference countries:
| Route | IVD Class | Timeline | Requirements |
|---|---|---|---|
| Declaration Route | Class A IVDs | Immediate (self-declaration) | Prior approval in any recognized reference country |
| Fast-Track 1 | Class B IVDs (FDA Class II equivalent) | 45 business days | 4 months market history in reference country |
| Fast-Track 2 | Class C IVDs (EU IIb equivalent) | 60 business days | 6 months market history in both EU and US |
| Standard Route | Class D IVDs | 120+ business days | Reference country approval required |
Required Documentation
- Prior approval documentation from a recognized reference country
- ISO 13485 certificate or equivalent GMP certification
- Performance evaluation data
- Labels and IFU (Hebrew for consumer-facing; English acceptable for professional use)
- Israel Registration Holder (IRH) appointment
Key Considerations
- The IRH bears legal responsibility for the IVD registration and must maintain a "state of control" with real-time post-market vigilance
- Using an independent IRH (rather than a distributor) is recommended to protect registration assets
- Annual renewal required for Declaration Route registrations (October 1 – December 31 cycle)
- The IRH must prepare periodic post-marketing reports and monitor global restrictions that might affect device safety in Israel
- Israel's IVD market was valued at $474.7 million in 2025, growing at 3.59% CAGR
Kuwait: MD 387/2025 IVD Framework
Regulatory Framework
Kuwait's Ministerial Decree No. 387 of 2025 established a structured framework for regulating the registration and circulation of IVD devices. The Medicine and Medical Products Registration and Regulatory Administration (MMPRRA) within the Ministry of Health oversees IVD registration.
IVD Classification
Kuwait uses a risk-based IVD classification system aligned with IMDRF principles:
| Class | Risk Level |
|---|---|
| IVD Class A | Low individual and public health risk |
| IVD Class B | Moderate individual risk, low public health risk |
| IVD Class C | High individual risk or moderate public health risk |
| IVD Class D | High individual and public health risk |
Registration Pathways
Under MD 387/2025, IVDs can follow the same three pathways as conventional devices:
- Standard Pathway — Full technical dossier review (6–8 months)
- Fast-Track Pathway — For devices addressing urgent healthcare needs (3–5 months)
- Abridged (Reliance) Pathway — Leverages existing marketing authorizations from recognized reference regulators (FDA, CE marking under EU IVDR, MHRA, TGA, PMDA, SFDA) (2–4 months)
Comparative IVD Registration Overview
| Parameter | Saudi Arabia (SFDA) | UAE (EDE) | Egypt (EDA) | Turkey (TITCK) | Israel (AMAR) |
|---|---|---|---|---|---|
| IVD classification | A–D (GHTF) | A–D (GHTF) | A–D (EU IVDR) | A–D (EU IVDR) | A–D (IVDR recognized) |
| Class A pathway | Listing only | Standard registration | Listing | Self-declaration | Declaration route (immediate) |
| Full review required | Class B–D | All classes (varying depth) | Class B–D | Class B–D | Fast-Track / Standard |
| Registration fee | SAR 19K–23K ($5.1K–$6.1K) | AED 5,100 ($1,389) | $450–$1,280 | Varies by class | No government fee |
| Review timeline | 35 working days | 45 working days | 6–8 months | Weeks to 6 months | Immediate to 120 days |
| Registration validity | 3 years | 5 years | 5 years (IVD) | Indefinite | 1 year (declaration) / ongoing |
| Language requirement | Arabic + English | Arabic + English | Arabic + English | Turkish | Hebrew (consumer) + English |
| Local representative | LAR mandatory | LAR mandatory | ERH mandatory | Turkish AR mandatory | IRH mandatory |
| CE/FDA accepted | Facilitates review | Required for Class II–IV | Recommended | CE marking required | Required (reference country) |
Oman: Drug Safety Center IVD Registration
Oman's Drug Safety Center (DSC), under the Ministry of Health, launched its IVD registration framework for Class C and D devices. In November 2025, the DSC published Guideline GD5 — "Guideline on Requirements of Class C & D In Vitro Diagnostics Device Registration in Sultanate of Oman" (First Edition, November 2025).
Key requirements:
- IVD devices must be classified under the A–D risk system
- Registration dossier includes IVD device information (trade name, model, serial number, classification, intended use, category, manufacturer device ID)
- IVD device grouping/bundling provisions are defined
- Class C and D IVDs require full technical documentation submission
- Reference market approvals (CE IVDR, FDA) facilitate the review process
Registration for Class C and D IVDs became mandatory following the MOH announcement in August 2025, with the full requirement taking effect by July 2026.
Point-of-Care Testing (POCT) in MENA
Point-of-care testing represents one of the fastest-growing IVD segments in MENA. The COVID-19 pandemic accelerated POCT adoption, and governments continue to invest in decentralized diagnostic capabilities. Key developments:
- Saudi Arabia's Vision 2030 healthcare transformation includes expanded POCT infrastructure in primary care centers and emergency departments
- The UAE's smart hospital initiatives incorporate POCT devices into connected health ecosystems
- Turkey's TITCK applies the same regulatory framework to POCT devices as to laboratory-based IVDs, requiring CE marking and ÜTS registration
- Israel's AMAR treats POCT devices as standard IVDs, with classification based on intended use and risk level
For POCT manufacturers, the registration pathway is the same as for laboratory IVDs in each country — there is no separate POCT-specific pathway in any MENA market.
Companion Diagnostics Across MENA
Companion diagnostics (CDx) are gaining regulatory attention across the region:
- Saudi Arabia: SFDA published dedicated CDx guidance (March 2025, MDS-G026) — the most comprehensive CDx framework in the region. CDx IVDs require coordinated review between the drug and device regulatory pathways, with clinical performance studies required per MDS-REQ1 and MDS-REQ2.
- UAE: CDx devices are registered as Class C or D IVDs through the standard EDE pathway. No CDx-specific guidance exists yet.
- Turkey: CDx devices follow the EU IVDR framework, classified as Class C IVDs requiring Notified Body assessment.
- Israel: CDx IVDs typically follow the Fast-Track or Standard routes depending on risk classification. No CDx-specific guidance.
- Egypt: CDx registration follows the standard EDA IVD pathway with performance evaluation requirements.
Strategic Recommendations
1. Start with Your Strongest Reference Market Approval
Every MENA country (except Turkey, which requires CE marking) accepts prior approvals from reference regulators as evidence. Having FDA clearance, CE marking under IVDR, or both significantly accelerates review in Saudi Arabia, the UAE, Egypt, and Israel.
2. Prioritize Saudi Arabia and the UAE
These markets offer the largest IVD opportunities and the most predictable regulatory timelines. Saudi Arabia's 35 working day MDMA review and the UAE's 45 working day EDE review are among the fastest in the region.
3. Prepare Performance Evaluation Data Early
Performance evaluation aligned with ISO 15189 and CLSI guidelines is required or recommended across all MENA markets. Investing in robust performance studies upfront reduces queries and delays across multiple country submissions.
4. Consider Turkey's Alignment Advantage
Turkey's full alignment with EU IVDR means CE-marked IVDs have a streamlined pathway — but ÜTS registration is still mandatory and Turkish language documentation is required.
5. Appoint Independent Local Representatives
Across all MENA markets, the local representative (LAR, ERH, Turkish AR, IRH) plays a critical role. Using an independent representative rather than a distributor protects your registration assets and allows flexibility in commercial arrangements.