We support businesses with medical device registration in the UAE, from product classification and documentation to EDE submission, follow-up, and Marketing Authorization.
Understand Your Product Requirements
We assess your product and identify the applicable regulatory requirements and documentation needed for EDE registration.
Prepare and Submit Your File
We prepare and review the required registration documents and coordinate the submission with EDE.
From Submission to Authorization
We follow up with EDE, handle regulatory requirements, and support the process through Marketing Authorization.
We assess your medical product and identify the applicable classification and regulatory requirements for registration.
We prepare and review registration documents, manufacturer and product certificates, and required technical information.
We submit your application to EDE and handle follow-up, regulatory clarifications, and authority requirements throughout the process.
We follow the application through to the issuance of the EDE Marketing Authorization Certificate, with renewal support when required.
We assess and classify your medical product to identify the applicable regulatory requirements.
We identify and prepare the required registration documents, technical information, and product details.
We review manufacturer and product certificates and coordinate Free Sale and conformity documents where required.
We submit the completed registration application and supporting documents to EDE.
We follow up with EDE and handle regulatory clarifications or additional requirements throughout the process.
We continue the process until the EDE Marketing Authorization Certificate is issued.
We provide ongoing support for renewal and regulatory requirements related to registered medical devices.
