MOHAP Medical Device Registration & Dossier Strategy

Registration Must Be Built Around a Consistent Regulatory Evidence Package. MOHAP registration enables medical equipment to be imported and traded in the UAE when the applicable conditions are met. A strong application depends on consistency between the local applicant, manufacturing site, product family, intended purpose, classification, country-of-origin evidence, conformity documentation, technical evidence and labeling.

Prepare Your MOHAP Registration

When This Support Is Needed

Registering medical equipment, consumables, IVDs, or SaMD with MOHAP for legal importation and sale in the UAE

Transitioning an existing product line to current MOHAP electronic portal standards

Adding new models, catalogue codes, sizes, or accessories to an active MOHAP registration certificate

Addressing MOHAP technical evaluation committee queries, document deficiencies, or sample requests

What We Challenge Before Submission

Are manufacturer and manufacturing site details registered in the MOHAP database prior to device submission?

Does the Free Sale Certificate explicitly include all submitted model variants and intended clinical indications?

Is there complete data consistency between the CE DoC, IFU, brochure, and MOHAP application forms?

Are high-risk device clinical evaluation reports and bench safety data defensible before technical committees?

Can physical samples and Certificates of Analysis be supplied within statutory MOHAP response windows?

Our MOHAP Dossier Compilation Scope

Registration readiness and dossier submission route assessment

MOHAP electronic system application form and administrative data preparation

Manufacturer registration and manufacturing-site qualification verification

Valid Free Sale Certificate (FSC) / Certificate of Free Sale authentication strategy

Country-of-origin (COO) and reference-market evidence compilation (US FDA, EU CE, Health Canada, Japan MHLW)

CE Declaration of Conformity (EU MDR / IVDR) and ISO 13485 QMS certificate review

Detailed product description, models, configurations, sizes, and commercial catalogue preparation

Safety and clinical efficacy evidence strategy, particularly for Class III and IV high-risk devices

Bilingual packaging labeling, Instructions for Use (IFU), and marketing brochure compilation

Physical sample, Certificate of Analysis (CoA), and laboratory testing readiness where requested

MOHAP technical query resolution and electronic resubmission management

Final MOHAP Registration Certificate review and regulatory handover

Data Cross-Check Standard:

We cross-check every major data point before submission: manufacturer name, product name, model list, intended purpose, classification, certificate scope, labels and technical evidence. Many avoidable delays originate from inconsistencies rather than a complete absence of documentation.

File Your MOHAP Medical Device Registration with Complete Dossier Defense

Our UAE regulatory specialists compile electronic dossiers, authenticate free-sale evidence, and resolve technical committee queries.

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