Medical Device Registration

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The UAE medical devices market size was $2.4 billion in 2021. The market is expected to grow at a CAGR of more than 6.7% during 2022-2025. As the UAE are almost entirely reliant on imports of medical devices, abundant opportunities are available for medical device companies to meet the country’s growing demand.
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Steps Involved in Medical Device Registration

①
Obtain a Commercial License in the UAE

The initial requirement for product registration is to obtain commercial trade license with relevant business activity. License could be either from Free Zone or from Main Land.

②
Register your company with MOHAP Portal

Register the company with MOHAP portal and create log in credentials.

③
File application for Medical device registration

Create application with mandatory documents and necessary product information.

④
Submit the application and make payment for MOHAP review

Pay the fee for registration.

⑤
MOHAP Review and product assessment

Authority review and assess the product, Send sample to MOHAP lab for analysis and issue Certificate of Conformity. If the analysis is passed, products will be approved for Marketing Authorization.

⑥
Registration Approval Marketing Authorization

Approval for Marketing Authorization will be given once the medical device is registered and the validity will be 5 years from the date of registration.

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Registration of Manufacturing Site

Manufacturing site registration is primary step in Medical device registration. In this process MOHAP will validate, whether the manufacturing site or facility where the product is manufactured is in accordance to the international standard and guideline.

Registration of Product

Medical device registration is the next step after manufacturing site registration. In medical device registration MOHAP will assess the quality and safety of device and once the product is approved a marketing authorization will be granted with validity five years for Agent or Local distributor to import and sell the pharmaceutical product in UAE market.

Documents Required for Registration

  • Certificate of Free Sale (CFS) or Certificate of Pharmaceutical products (CPP)
  • ISO 13485 Certificate
  • CE Certificate
  • GMP Certificate
  • Manufacturing License
  • Three samples of the products

Labelling Requirements

  • Product Name
  • Brand Name
  • Manufacturer details: Name, Address, Web address of manufacturer or Agent acting in UAE
  • Ingredients
  • Made in (Country)
  • Dosage and Instruction to use
  • Product indication / intended use
  • Health Warning
  • Storage Condition
  • Barcode
  • Pack Size
  • Production date & expiry date
  • Batch Number

How Gulf Scientific Liaison (GSL) can assist you?

Our technical team will review and analyse the registration documents and artwork labels are in accordance with MOHAP medical device technical guidelines. Our experts will advise if any additional documents or information’s are required. Our specialists will perform the medical device registration application in MOHAP portal, track the application and liaise with MOHAP officers and MOHAP lab offices to facilitate the successful product registration and extend our support for MOHAP Import permit approval at customs clearance inspection till your product reaches in your Medical Warehouse.
If you appoint GULF SCIENTIFIC LIAISON (GSL) as your UAE agent, we will assist you with the above and ensure you meet all regulatory requirements for selling your Medical Devices in the United Arab Emirates.
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Product Registration

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