Medical Device Compliance in the UAE

Absolutely not; you cannot be compliant or even eligible for direct registration of your medical device as a non-UAE person.
As per the rules and regulations, you will need to appoint a locally registered and licensed establishment for the distribution & import of goods and a UAE-resident entity as your official point of contact with the EDE. Your AR and distributor can be the same entity.

Yes, all foreign manufacturers applying for registration must possess the quality management system ISO 13485 certification to be eligible for registration and subsequent renewals of their medical devices. Basically, you cannot proceed with import or distribution approvals without the required ISO 13485 certification.

Your class and category will decide the paperwork for your application. For example, a higher risk requires a more detailed dossier, documents, extensive review by the authorities, and post-market obligations.

The primary compliance includes incident reporting, advertising/promotional compliance, renewal of the registration, recall procedure, vigilance process, adverse-event reporting, import licensing, import-export approvals, tech documentation, ISO, and CE Mark/FDO approvals.

Post-market surveillance is basically ongoing monitoring of your product’s safety in the market after launch and distribution. You must track its performance, detect any issues, and fix them with corrective actions.

It is a systematic reporting mechanism through which you must track, evaluate, and report any type of adverse or safety-related incident connected to your devices. This post-market compliance aims to safeguard patients and also facilitates mandatory product recalls whenever required.

Well, during a recall, the affected medical devices may be removed, repaired, replaced, or corrected, and you will also need to inform both the authorities and the customers.

Of course, the labels and instructions for use on your medical devices are one of the most important factors in compliance. Both must be in Arabic and English on the original packaging and must be approved by the EDE during the registration before the devices are imported and promoted in the market.

First, you need a proper device registration in the UAE through an authorized representative and/or a locally registered licensed establishment that can help you with import and distribution.
Secondly, you need a separate permit for import/export each time for the import of the registered products.

You will have to pay penalties, have your registration cancelled by the EDE, incur expensive reexports, delay in shipment, seizure of your consignment due to various reasons such as a lapsed registration, improper labelling/IFU, outdated documentation & global standard certification, or no import licensing or approvals.

You need to apply for the registration at least 3 to 6 months before your current one expires. Make sure to renew it within the timeline to avoid filing for a fresh registration. Submit your previous certificates, labels, ISO, IFUs, and other documents along with new modifications/changes as per your device updates.

Absolutely, if your software falls under SaMD (the ones that don’t require alignment with a physical device, like AI apps and diagnostic apps) and SiMD (the types that work with hardware like an MRI machine.

• Expert knowledge on UAE regulations and constant rule tracking, so you never miss an update- we also help you implement the said changes.
• Accurate and complete classification- so you don’t face any early rejections and late resubmissions.
• Networking and appointments with licensed and registered UAE entities for coordination and local support that helps you register from your home country.
• Accurate technical dossier and document legalization/attestation, so you don’t have to undergo registration delays.
• Import licensing for the local registered entity, if not done already, along with shipment approval paperwork after registration.
• On-time renewals before your registration lapses to make sure your business operations are uninterrupted, saving you from hefty financial penalties and re-registration.
• Ongoing support to conduct surveillance, report changes, adverse event and incident reporting, and product recall management.

Registration is merely enrolling your device with the Emirates Drug Establishment, and compliance means constant ongoing fulfilment of your obligations across the device’s lifecycle as per the UAE regulations.