Middle East
Accelerate your product launch with our proven expertise in the Middle East market entry.
Ongoing compliance coordination
As an MD or IVD manufacturer, you’re familiar with the complexities of registration across the Middle East dealing with varying frameworks that rely increasingly on regulatory reliance models. These include SFDA (KSA), MOHAP (UAE), and equivalent systems in Bahrain, Oman, and Qatar, all of which mandate in-country representation, Arabic documentation, and post-market compliance monitoring.
We at Qserve simplify this complexity by operating through local partners and acting as your authorized or responsible representative, ensuring smooth country-specific registration, submission of documentation (including Arabic labels), regulatory liaison, and ongoing compliance coordination.
Market knowledge
Discover how we can help:
Saudi Arabia (SFDA) Market Access
We manage MDMA registrations, risk-based classification (Class A–D), local product testing, Arabic translations, and SFDA dossier submissions.
Saudi Arabia Authorized Representative
We manage your licensed in-country AR , submitting registrations, vigilance reports, UDI to GHAD, handling label changes, renewals, and recalls.
UAE (MOHAP) Market Access
We prepare medical registration dossiers, Arabic documentation, coordinate technical committee submissions, and obtain 5-year MOHAP approvals.
UAE Local Agent
We serve as your UAE Agent, handling MOHAP communications, import license liaison, annual certificate renewals, and local regulatory updates.
GCC & Wider Middle East
We facilitate registration via reliance mechanisms, coordinate Arabic technical files, set up local representation, and ensure ongoing conformity across multiple jurisdictions:
- • Bahrein
- • Oman
- • Qatar
- • Iraq
- • Jordan
- • Lebanon
- • Syria
- • Israel
- • Yemen
- • Iran
Attempting Middle Eastern market access without region-specific know-how can lead to incorrect classification, and consequently, delayed market approval.
We offer complete registration support through an integrated regional network coordinated under one service umbrella. We provide clarity, consistency, and compliance, allowing efficient market rollout and enduring regulatory coverage.
Do you want predictable market approval in the Middle East using one supplier?
Couldn't find your question?
Do all GCC countries require a local Authorized Representative?
Yes, Saudi Arabia, UAE, Bahrain, Oman, Qatar, and Kuwait each mandate a licensed in-country representative (AR or Agent) to facilitate registrations, renewals, and vigilance.
What is a reliance pathway, and which countries use it?
Reliance pathways allow regulators (e.g., Saudi Arabia, UAE, Jordan, Egypt) to accept approvals from trusted authorities (like the FDA/EC), streamlining reviews in exchange for referencing third-party assessments.
Are Arabic-language documents mandatory?
All technical files, labeling, and IFUs must include Arabic translations to meet local requirements and facilitate registration and use.
Can one consultancy manage registration across the region?
Our Middle East-focused team supports dossier alignment, translation, representation, and compliance across all GCC countries and the broader region.