Our Emerging market series continues! In previous Emerging markets articles, we looked in detail at some of the largest medical device markets, specifically Asia Pacific, Middle East, and Latin America and further analysed a selection of the markets in each region.
Now, we’re looking into those territories once again to offer a more succinct look at some of the other potential access markets in those regions. For the second instalment of this series, we’re focussing on the United Arab Emirates.
UNITED ARAB EMIRATES (UAE) – an overview
The UAE is made up of seven emirates including Abu Dhabi and Dubai and is one of the wealthiest countries in the Middle East. The medical devices market is anticipated to undergo impressive growth over the next few years on the account of a surge in demand for new innovative devices and increased investment in the local healthcare industry.
To access the UAE foreign medical device manufacturers must register both the manufacturing site and the medical device with the UAE Ministry of Health and Prevention (MOHAP) via the Registration and Drug Control Department (DRCD). The requirements for UAE device registration broadly follow recognised regulations such as the EU and US FDA. There is a simplified registration process for Devices which have received approval from recognized country including Europe, the US, Australia, Canada, or Japan.
As with most international markets foreign manufacturers must appoint a licensed and authorised representative residing within the UAE to act as their Authorized Representative. The authorised representative must be formally assigned and licensed by MOHAP, they will handle device classification, device application processes and other legal obligations and responsibilities after placing the device on the market.
Risk classification for medical devices in the UAE
Medical Devices in the UAE are categorised into four risk-based types (Class I to IV) which consider the device intended use, duration of use and the degree of invasiveness. The authorised representative will process a classification submission for the manufacturer’s device via the MOHAP e-service and obtain a classification designation from the authorities.
Manufacturing site and device registration submissions are also submitted and processed via the MOH online portals. The authorised representative will be required to submit the application forms, technical documentation, certifications, and manufacturing site information. Quality Management System certification to ISO13485:2016 standards is required as part of the manufacturing site registration. Upon review and approval, the device and site where the device is manufactured will be granted a license certificate. Once the manufacturing site is registered any subsequent device submissions for those devices manufactured at the same site only require device registration.
Final things to consider before entering the UAE medical device market:
- Manufacturers may appoint their distributor as their authorised representative. However, having an independent Local Representative, with no commercial interest, would provide more flexibility to appoint multiple distributors in the UAE.
- As well as submitting registrations the authorised representative should also be able to carry out the listing of the medical device(s) to meet some of the Emirate states additional individual listing requirements, such as Abu Dhabi and Dubai.
If you would like a full requirement summary or a review of access routes specific to your device please contact IMed at hello@imedconsutlancy.com