This message was posted by a user wishing to remain anonymous
Hello,
My team has obtained UAE approval for a CE Marked device (EU Class III). We worked with our distributor to obtain the approval; your distributor should know what is required and be able to provide you with directions. The documentation required was minimal-our CE certs, a certificate of free sale, a letter of authorization (apostilled), labeling, and some basic product information and declarations. We also needed to obtain a classification letter from MOHAP, which was managed by the distributor. I assume a similar pathway exists for FDA-approved/cleared devices.
The way it was explained to us, there are two paths: one is essentially an import approval (so there's a mini-approval process for each importation), and the other is a full approval. We started with the first then proceeded with the second, but the difference between what we needed to submit was not very different for the two paths.
I've attached an infographic we were provided, describing the import pathway (caveat: this is a year or two old, so I can't guarantee it's still accurate).
I hope this helps you get started!
Original Message:
Sent: 04-Dec-2022 07:00
From: Anonymous Member
Subject: Export to United Arab Emirates
This message was posted by a user wishing to remain anonymous
I need to put together a plan for exporting devices to United Arab Emirates. I don't have any experience with International requirements. My experience is limited to US. Does anyone have guidance on how to begin this research? Is it possible that United Arab Emirates acknowledges FDA approvals? Some devices are Class II and some are patient specific where we perform a service for a doctor by assembling a device based on an Rx. Thanks in advance for any guidance you can provide.