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 Emirates Gateway

The United Arab Emirates (UAE) is an emerging market for Israeli medical devices companies.

Like in other countries, Medical Devices are regulated by a local dedicated Control Department. whose objective is to ensure the safety, efficacy, and quality of all registered medical devices. Federal and Emirate level regulates healthcare. The UAE Ministry of Health regulates the registration of medical devices to maintain a balance between product safety, quality, and effectiveness.

 

UAE Medical Device Regulations

 

All medical devices must be approved by the UAE Ministry of Health Drug Registration and Control Department. Imported medical devices will not be cleared by Customs unless a pre-approval for the importation of the consignment is issued by MOH.

If the exporter company/manufacturer has no legal presence in the UAE, it will have to appoint a local representative to act on its behalf to register the devices. 

The local representative must be appointed by a written contract stating the appointment of the local authorized representative by the company. The local representative should be licensed by the Ministry of Health.

 

UAE Qualification of registration of Medical Devices

 

An application to register a medical device in the UAE must be made by the device manufacturer or its local representative/distributor. The local representative/distributor must be formally authorized by the manufacturer to handle the application process and the manufacturer’s legal obligations and responsibilities concerning placing the medical device in the UAE market. The authorized representative/distributor must be available to interact between the medical device manufacturer and the Ministry of Health.

 

This is just a sample of many more written and oral rules and information we will share with you and provide while you decide to enter this promising and growing market.

 

Hamada regulatory experts will provide the regulatory support and keys to enter this expanding market.  From our side, it could start with a registration process.

Regulatory, Clinical & Quality Affairs for the MedTech Industry

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