UAE Medical Device Registration: EDE (formerly MOHAP)

Federal medical device market authorization in the United Arab Emirates is administered by the Emirates Drug Establishment (EDE). Older materials may refer to MOHAP, but manufacturers planning a current filing should follow EDE's service requirements and portal instructions. The official EDE marketing-authorization service lists the current prerequisites, service standard, fees, and validity period.

UAE classification and route planning

The regulatory route starts by confirming that the product is a medical device or IVD and determining its risk classification. The intended purpose, duration of use, invasiveness, active functions, and potential consequences of failure affect classification and dossier depth. Borderline or combination products may need an EDE classification decision before the marketing-authorization application can proceed.

The EDE service currently describes company and manufacturing-site registration as prerequisites for device marketing authorization. It also identifies an eligible local applicant, such as a licensed medical warehouse or marketing office, as part of the filing structure. Foreign manufacturers should therefore plan local representation, establishment readiness, and product work as one connected program rather than treating the product application in isolation.

UAE medical device dossier

A typical submission includes manufacturer and site information, an authorization letter, quality-management-system evidence, reference-market approvals or conformity evidence where applicable, device descriptions, intended use, classification, labeling, instructions for use, test reports, and clinical or performance evidence appropriate to risk. Arabic requirements and the exact product information shown in the portal should be checked before filing.

EDE publishes a 45-working-day service completion target for this service when a complete application is accepted, together with current application and authorization fees. These are service standards, not a guaranteed end-to-end launch date: classification questions, prerequisite registrations, deficiency responses, and document legalization can extend the project.

Maintenance and post-market obligations

The published EDE service states a five-year authorization validity, subject to current rules and continued compliance. Manufacturers and local applicants must keep company, site, quality certificates, labeling, and product information current. Complaints, adverse events, recalls, and field safety corrective actions need local procedures. Proposed changes should be assessed before implementation to determine whether EDE notification, amendment, or a new application is required.

UAE pathway and evidence decisions

The EDE service page publishes a five-year authorization validity and a 45-working-day service duration. Those figures describe this service, not the entire time from first company enrolment to commercial launch. Confirm the portal scope and actual certificate; unrelated drug boilerplate must not be turned into a universal medical-device bioequivalence requirement.

Use the official EDE instructions for the filing scope. Maintain a controlled record of the chosen route, current evidence, open gaps, responsible parties and authority responses. Separate fees, document preparation, review and applicant work when planning the launch.

For a multi-country program, use the market directory to coordinate evidence reuse while retaining the local applicant, language, registration and postmarket requirements for each destination.