UAE Authorized Importer

Streamline your regulatory compliance with Razalution as your UAE Authorized Importer (IAI) for medical device and IVD manufacturers.

Introduction

The UAE Authorized Importer (IAI) is a crucial entity responsible for device registration, acting as a liaison between the manufacturer and the regulatory authorities in the UAE. Our team at Razalution takes on the role of IAI, holding the necessary registration and license to import products under our name, providing you with regulatory control and commercial oversight over your chosen distributors in UAE.

Key Challenges of Selecting Distributors as UAE Authorized Importers

• Multiple Registrations Required
• Technical Documentation Sharing
• Regulatory Knowledge Gap
• Role Conflicts
• Labeling Complexities
• Customs Clearance Hassles

Razalution as your single designated UAE Authorized Importer

Razalution Global offers UAE Authorized Importer services to allow device manufacturers to maintain regulatory control over placing their devices on the UAE market, maintain post market regulatory compliance, and provide for more commercial control over the manufacturer's selected distributors in UAE. We maintain the required wholesale license – Forms 20B and 21B/21C – to allow us to act as your single designated UAE Authorized Importer.

UAE Authorized Importer Service Overview

The device approval process in UAE from start to finish takes between six and nine months to complete. If all is in order, CDSCO will issue a market authorization for your devices through the Import License Form MD-15. Market authorization does not expire for as long as UAE Authorized Importer pays the applicable import license fee every five years. As your UAE Authorized Importer, Razalution provides the following services:

Device Registration

• Confirm that your device has approval in Australia, Canada, Japan, European Union (EU) and US, plus confirm approval in your home country.
• Confirm that your device is included in the CDSCO listing of devices that require registration in UAE and, if not included, verify that your device has not been listed in UAE's Gazette Notifications at a later date.
• Confirm device classification and device grouping per UAE regulations and requirements, this determines how to group the devices and classification for UAE.
• Provide local support on the Registration of predicate products as per the Approved Medical Device Listing published by the CDSCO.
• Comply with the registration obligations by the CDSCO in UAE under the revised Medical Device Rules are G.S.R. 78(E) and prepare the Technical Documentation File (Submission Dossier).
• Prepare the Technical Documentation File as per the UAEn Online Portal Requirements (SUGAM).
• Upload documents and pay the CDSCO fees on the SUGAM portal.
• Assist in preparing responses to queries raised by CDSCO on the dossier submitted.
• A minority of devices such as novel devices require review by CDSCO's Special Expert Committee (SEC). Should your devices require a SEC review, we will provide support with the preparation of the clinical data for presentation to the SEC, and attend the meeting with your regulatory representative(s).
• Register, where applicable, your medical device(s) with the CDSCO (MD-14 application).
• Based on your device type, you may need other specific licenses such as, but not limited to, Electronic Waste Disposal License, BIS Certificate, for batteries supplied with your medical products, PC & PNDT certificate, for ultrasound devices, Atomic Energy Regulatory Board Certificate, for x-rays and other radiation related products, etc. We help you navigate these additional requirements in UAE to ensure minimal disruption to your supply chain.

UAE Importer License Holder

• Provide authorization to place, IAI name/address on your labeling, packaging, and instructions for use when applicable
• Keep an available copy of the Technical Documentation, and other submitted paperwork, including any amendments and supplements, at the disposal of CDSCO, when requested
• Upon CDSCO's request, provide all the information and documentation necessary to demonstrate the conformity of a device.
• Forward the manufacturer any request, to CDSCO, for device samples, or access to a device, and confirm receipt or access with CDSCO
• Cooperate with CDSCO on any preventive or corrective action taken to eliminate or mitigate the risks posed by the medical devices.

Importation into UAE

• Verify that the device labeling fulfils UAE's regulatory labeling requirements
• Determine the duty structure and taxes which will be levied on your devices by the UAEn Customs Authorities at the port of clearance.
• Verify all shipping documents (invoice, packing list, and Batch Release Certificate) accompanying each consignment prior to the dispatch from the manufacturer's location for local compliance and smooth customs clearance
• Prepare and supply all the required Customs Clearing Documents to the Customs House Agent (CHA) and provide necessary support for the clearance of goods at the UAEn Port
• Support your channel partners to import goods at a port of their convenience and get attractive rates for Freight, Clearance, and local transportation.
• Liaison with the Clearing Agent and/or Customs Authorities, to address any queries on the goods being imported.
• Support you in supplying your products to multiple distributors across the country.
• Stock local supplies if needed for emergency stock requirements by your partners.