Technical Documentation & Safety / Performance Evidence

Technical Documentation Must Substantiate the Product Being Registered. MOHAP may review the evidence supporting the device's safety, efficacy/performance and conformity. The dossier should therefore tell one consistent story from intended purpose and risk through verification, validation, clinical/performance evidence and labeling.

Review Your UAE Technical File

When This Support Is Needed

Compiling a comprehensive technical dossier for Class I, II, III, or IV MOHAP registration

Adapting an overseas EU MDR/IVDR technical file or US FDA 510(k)/PMA dossier for the UAE market

Responding to MOHAP technical evaluation committee requests for safety and performance evidence

Verifying end-to-end traceability between risk mitigations, test reports, and marketing brochure claims

What We Challenge Before Submission

Is the tested device configuration identical to the finished commercial article to be supplied in the UAE?

Do pre-clinical laboratory reports substantiate the exact clinical claims made in the product brochure and IFU?

Are test standards and version editions recognized and accepted by MOHAP technical evaluators?

Are worst-case product selection rationales scientifically defended in mechanical and biological test reports?

Do all risk mitigation controls in the risk file have corresponding, verified test evidence?

Technical File Components We Compile & Review

Device description, engineering specifications, models, configurations, and accessories

Intended clinical purpose, indications, contraindications, and marketing claim alignment

Design and manufacturing process flows, critical supplier evaluations, and facility controls

Risk management file and benefit-risk documentation under ISO 14971

Applicable international standards review and conformity evidence mapping

Biological evaluation and biocompatibility testing evidence (ISO 10993 series)

Sterilization validation and sterile barrier packaging integrity reports

Packaging transit simulation and real-time / accelerated shelf-life aging evidence

Electrical safety and Electromagnetic Compatibility (EMC) testing reports (IEC 60601)

Software lifecycle documentation, architecture, and cybersecurity verification (IEC 62304)

Usability and human factors engineering documentation (IEC 62366-1)

Clinical evaluation reports (CER) and clinical safety/efficacy evidence for medical devices

Analytical and clinical performance evaluation evidence for IVDs

Bilingual labeling, Instructions for Use (IFU), and promotional brochure consistency review

Post-market surveillance plans and lifecycle documentation update procedures

Traceability Standard:

We review evidence traceability: Intended Purpose -> Classification -> Risk -> Verification / Validation -> Clinical or Performance Evidence -> Labeling. A report is not sufficient merely because it exists; it must apply to the marketed configuration and support the claims being registered.

Harmonize Your Technical Dossier for UAE MOHAP Review

Our regulatory engineers compile technical documentation, map evidence matrices, and review pre-clinical data for MOHAP conformity.

Book a Consultation