MedTech, Medical Devices & IVDs.
End-to-End SFDA MDMA, MDNR Approvals & Technical File Authoring
Engineered compliance across the product lifecycle.
Muhrat Al Marasim acts as your regulatory conduit into Saudi Arabia and the GCC for medical devices, in-vitro diagnostics (IVDs), active implantables, and software as a medical device (SaMD). We navigate the rigorous SFDA MDMA classification, Technical Documentation (TFA), risk management (ISO 14971), and post-market surveillance requirements across KSA and the UAE.
Guaranteed Statutory Deliverables
Select the documentation components currently available for your product:
Our senior directorate will conduct an initial gap analysis of your dossier before statutory filing.
Medical Devices
Saudi Arabia • Egypt • UAE • MENA Region
United Arab Emirates
Product listing with Abu Dhabi Health Authority (HAAD) and Dubai Health Authority (DHA), as well as registering medical products with the Emirates Authority for Standardization and Metrology (ESMA).
We also manage all post-marketing duties, guaranteeing full compliance and a smooth path to market across the Emirates.
Our support ensures that your products meet all regulatory requirements, achieving compliance and a hassle-free launch across the UAE market.
Regulatory Process Timeline
Select your target market to view the authority-specific registration pathway for Saudi Arabia, the UAE, or Egypt.
Define registration strategy across HAAD, DHA, and ESMA requirements and appoint the UAE authorized representative.
Compile device technical documentation, ISO 13485 certificates, labeling, and Free Sale Certificate for UAE submissions.
File product listings with Abu Dhabi and Dubai health authorities and register with ESMA where applicable.
Manage technical queries and deficiency responses until product listing and import authorization are confirmed.
Handle renewals, variations, adverse event reporting, and ongoing compliance across UAE emirates.
Required Documents
Select your target market to view the authority-specific documentation required for Saudi Arabia, the UAE, or Egypt.
Technical Documentation
- Device description and classification rationale
- Risk management file (ISO 14971)
- Clinical evaluation report
- ISO 13485 certificate and FSC
Authority Submissions
- HAAD product listing application (Abu Dhabi)
- DHA product listing application (Dubai)
- ESMA registration documents (where applicable)
- UAE authorized representative agreement
Labeling & Import
- Device labeling and IFU (Arabic/English)
- Import and distribution authorization
- Emirate-specific clearance documents
- Post-market surveillance plan