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Reanny Medical Devices Management Consulting Co., Ltd.

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Head Office

0755-27391220

Guangzhou Company

020-82513196

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United Arab Emirates Registered Agent Service
United Arab Emirates Registered Agent Service
The United Arab Emirates, or UAE for short, with its capital in Abu Dhabi, is an Arab country bordering Saudi Arabia. In the UAE, medical devices and in vitro diagnostic medical devices are regulated by the Drug Control Department under the Ministry of Health and Prevention (MOHAP).
It is worth noting that foreign companies in the UAE need to find a legitimate local agent to submit medical device classifications and registrations and to communicate with MOHAP. At the same time, the local representative in the UAE also has a very important role that cannot be replaced, that is, the applicant for the import permit, only through the local representative can be carried out after the product has been certified import permit application and issuance, which means that your local representative still need to assist you to complete the subsequent import issues.
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0755-27391220

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STEP 1 Appointment of UAE Authorised Representative (Agent)

According to the UAE medical device regulations, non-local legal manufacturers/applicants are required to appoint an Authorised Representative (Agent) company to act as the contact person for the relevant device in the UAE. The Authorised Representative will be responsible for product compliance and post-market surveillance.

STEP 2 Determine the classification of the product

Determine the classification of your device according to the MOHAP classification rules (application submitted by the UAE Authorised Representative and classification approval obtained).

STEP 3 Prepare technical documentation and systems

The company needs to prepare the documents to be submitted according to the requirements of MOHAP and prepare the system certificate (recognised as ISO13485).

STEP 4 Submission of Technical Documents to MOHAP The manufacturer transfers the completed technical documentation to an authorised representative in the UAE, who then submits it, accepts the questions, and responds to corrections. STEP 5 MOHAP Approval Once MOHAP is granted, the licence holder (always the legal manufacturer) can ship the goods to the UAE for sale.
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Head Office

0755-27391220

Guangzhou Company

020-82513196

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reanny@reanny.com