The Opportunity in the Middle East
The Middle East represents one of the fastest-growing IVF and Assisted Reproductive Technology (ART) markets globally, fueled by rising infertility rates, expanding private healthcare, and supportive government initiatives. But market entry depends on mastering regulatory pathways that remain diverse and evolving.
For manufacturers, success in 2025 means preparing IMDRF-compliant dossiers, securing trusted local Authorized Representatives (ARs) or Marketing Authorization Holders (MAHs), and navigating new digital submission portals, UDI requirements, and post-market vigilance obligations.
Common Principles Across the Region
- Risk-based classification: Aligned to GHTF/IMDRF standards.
- Local AR/MAH mandatory: Required to submit dossiers and hold licenses.
- Digital submissions: Increasingly the standard, with bilingual documentation (Arabic/English).
- Post-market vigilance: UDI traceability, incident reporting, and labeling localization are non-negotiable.
Saudi Arabia (KSA) — The Regional Benchmark
- Authority: Saudi Food and Drug Authority (SFDA)
- Pathway: All devices require a Medical Devices Marketing Authorization (MDMA). Applications are fully electronic, IMDRF-aligned, and include clinical data, risk management, bilingual labeling, and a PMS plan.
- UDI: The Saudi-DI program is mandatory for labeling, packaging, and database entry.
- 2025 Focus: IVF software/AI (e.g., embryo-scoring) is scrutinized under digital-health guidance. Pre-submission meetings are strongly advised.
United Arab Emirates (UAE) — The Efficient Hub
- Authority: Ministry of Health and Prevention (MOHAP)
- Pathway: Two steps — company/MAH registration, then device registration. Requires ISO 13485, CSDT/MDR-style file, and local warehouse/MAH license.
- Timeline: MOHAP targets 45 working days for complete applications.
- IVF Insight: Reference approvals (CE/FDA) can expedite review, but full UAE registration is still required. All claims must align with the IFU and advertising rules.
Egypt — The Volume Market
- Authority: Egyptian Drug Authority (EDA)
- Pathway: Fully electronic submission; timelines typically 4–9 months. A local Egyptian Registration Holder (ERH) must be appointed.
- 2025 Update: Vigilance and incident reporting procedures have been tightened.
- IVF Insight: Culture media and consumables require biocompatibility & performance evidence. IVF software must demonstrate human factors validation & cybersecurity safeguards.
Jordan — JFDA
- Authority: Jordan Food & Drug Administration (JFDA)
- Pathway: Risk-based classification, CSDT/MDR-style file. Local AR mandatory.
- Certificates: Valid for up to 10 years.
Qatar — MoPH
- Authority: Ministry of Public Health (MoPH)
- Pathway: Local partner required. Documentation includes corporate license, technical file, and labeling.
- 2025 Update: AI/innovative devices are reviewed case-by-case; regulatory expertise of AR is crucial.
Bahrain — NHRA
- Authority: National Health Regulatory Authority (NHRA)
- Critical Deadline: Mandatory device registration from 1 Feb 2026.
- Pathway: Applicants must first register as a medical device establishment, then proceed via the NHRA e-submission system.
- Tip: Early action is key to avoid disruption.
Oman — DGPA&DC
- Authority: Ministry of Health, Directorate General of Pharmaceutical Affairs & Drug Control
- Pathway: Local agent required; applications submitted electronically with GHTF-aligned dossiers.
- Update: New 2025 circulars have introduced stricter import requirements.
Kuwait — MOH
- Authority: Ministry of Health (Drug & Food Control)
- Pathway: Based on Ministerial Decree No. 13/2022. Requires local AR, full technical file, and legalized documentation.
- Note: Expect evolving review processes; confirm current requirements before submission.
Strategic Roadmap for 2025
- Build a Master Dossier
Use the IMDRF Table of Contents format and localize for each market. - Select AR/MAHs Early
Your local partner is your legal face to the regulator. Prioritize IVF/ART experience, e-submission access, and vigilance capacity. - Embed UDI & Vigilance
With Saudi-DI live and Egypt/NHRA tightening PMS, these are core compliance obligations, not afterthoughts. - Use Reference Approvals Wisely
CE/FDA approvals add credibility but do not replace local registration, labeling, or advertising rules. - Plan for Timelines
MOHAP (UAE) can be as short as 45 days; Egypt 4–9 months; SFDA (KSA) depends on dossier quality; Bahrain will close its transition by Feb 2026.
How FinDBest IVF Helps
At FinDBest IVF, we accelerate market access by:
- Identifying pre-vetted ARs & distributors across KSA, UAE, Egypt, and other Midldle East markets.
- Validating partners based on IVF expertise, RA readiness, and vigilance systems.
- Cutting partner qualification and onboarding time by up to 50%, ensuring faster entry and compliance.
Sources & References
- Saudi Arabia (SFDA) – Medical Devices Marketing Authorization (MDMA), Saudi-DI UDI requirements, and vigilance guidance.
- SFDA Official Website
- Qserve Group: 10 Things You Should Know About RDC 751/2022
- Emergo by UL: Saudi Arabia Medical Device Regulations
- United Arab Emirates (MOHAP) – Device registration service, classification, and fee structure.
- MOHAP Medical Device Registration Service
- Emergo: UAE Medical Device Regulatory Framework
- Egypt (EDA) – Medical device registration and vigilance guidelines.
- EDA Official Portal
- Freyr Solutions: Egypt Medical Device Regulations
- Jordan (JFDA) – Device classification, AR requirements, and registration validity.
- JFDA Official Website
- Qatar (MoPH) – Regulatory procedures for device registration and accreditation.
- Bahrain (NHRA) – Device registration guidance (mandatory from Feb 2026).
- NHRA Bahrain
- Oman (DGPA&DC) – Directorate General of Pharmaceutical Affairs & Drug Control medical device regulations.
- MOH Oman
- Kuwait (MOH) – Medical device regulatory framework under Ministerial Decree No. 13/2022.
- MOH Kuwait
Acronyms
| Acronym | Meaning |
| AR/MAH | Authorized Representative / Marketing Authorization Holder |
| CSDT | Common Submission Dossier Template |
| EDA | Egyptian Drug Authority |
| IMDRF | International Medical Device Regulators Forum |
| JFDA | Jordan Food & Drug Administration |
| MDMA | Medical Devices Marketing Authorization (KSA) |
| MOHAP | UAE Ministry of Health & Prevention |
| NHRA | Bahrain National Health Regulatory Authority |
| SFDA | Saudi Food & Drug Authority |
| UDI | Unique Device Identification |
