MedTech, Medical Devices & IVDs.
Precision regulatory guidance for MedTech manufacturers, IVD developers, active implantables, and clinical hardware creators seeking sovereign market access across Saudi Arabia, the UAE, and the MENA region.
MedTech, Medical Devices & IVDs
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.
SFDA Statutory Pathway Comparison Matrix.
Compare submission pathways, statutory authorities, review cycles, and mandatory local requirements across medical device classifications and therapeutic sectors.
MedTech Class I / Low Risk
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
Need a formal classification opinion for your technology?
Our senior regulatory directors review your existing CE MDR or US FDA technical files, classify your device under Saudi MDS-REQ rules, and construct an actionable timeline within 48 hours.