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UAE Regulatory Process EMERGO

The document outlines the regulatory process for medical devices and in vitro diagnostic devices in the United Arab Emirates. The process is overseen by the Ministry of Health and Prevention and involves classifying products, appointing a local representative, preparing documentation, submitting applications, and potentially undergoing inspections before obtaining necessary approvals and permits to market products in the country.

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456 views1 page

UAE Regulatory Process EMERGO

The document outlines the regulatory process for medical devices and in vitro diagnostic devices in the United Arab Emirates. The process is overseen by the Ministry of Health and Prevention and involves classifying products, appointing a local representative, preparing documentation, submitting applications, and potentially undergoing inspections before obtaining necessary approvals and permits to market products in the country.

Uploaded by

zakirahzaidi1
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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United Arab Emirates

Regulatory Process for Medical Devices & IVDs

Medical devices and in vitro diagnostic devices (IVDs) are regulated by the Ministry of Health and Prevention (MOHAP),
Drug Control Department. The regulatory framework is based on Federal Law No. 8 of 2019 and associated guidance.
However, the regulatory system in the UAE is primarily based on case-by-case decisions by the MOHAP, and the written
guidance is not always followed in practice. This chart presents a generalized overview of the approval process, but due to the
case-by-case nature of the regulatory system, the process can vary considerably for each device.

Appoint a Local Authorized Representative (Agent).

Agent submits a classification request to the MOHAP, who reviews key product information including the intended use and
global marketing approvals. Upon review, the MOHAP issues a Classification Letter.
The Classification Letter details the risk classification and whether the product is subject to registration.

The following steps are applicable to devices subject to registration with the MOHAP, as detailed in the Classification Letter.
For devices not subject to registration, an Import Permit from the MOHAP is generally still required.*

Class I MD Class II MD Class III MD Class IV MD


Class A IVD Class B IVD Class C IVD Class D IVD

Prepare technical files and accompanying documents for submission.

The Agent submits the application via the Business Services page on the MOHAP website. Pay regulatory service fees.

A pre-registration GMP inspection or quality system audit may be conducted to verify compliance.

The Drug Control Department


reviews the submission and The Drug Control Department reviews the application and issues a
issues a Listing Certificate Registration Certificate upon approval.
upon approval.

You may begin marketing your device in UAE. Maintain post-market obligations. Import permits from the MOHAP are
required to bring the products into the country.

* If your product is identified as exempt from Registration or Listing based on the Classification Letter issued by MOHAP, your product must still conform with the UAE labeling requirements and must have the
following documents to obtain an Import Permit: (1) Quality Management System Certificate issued by a recognized body, (2) Proof of approval in the country of origin, (3) Declaration of Conformity
(for Class I devices).
This is a simplified overview of the process. Additional steps may be required depending on the classification of your device and quality of technical documentation.

© 2020 Emergo by UL - Have comments or suggestions about the content of this chart? Email us at [email protected]. Table updated 11/2020. EmergobyUL.com

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