MOHAP UAE Medical Device Registration

The United Arab Emirates, with its strategic location and robust healthcare infrastructure, is a burgeoning market for medical devices. The country's commitment to healthcare excellence and innovation, combined with a growing population and increasing health awareness, makes it an attractive destination for international medical device manufacturers.

UAE
Device Classification and Regulatory Pathways

Aligning with the UAE's MOHAP Regulations

Regulatory Authority

Pure Global can assist with UAE's medical device registration, ensuring MOHAP approval to sell in the Emirati market.

Classification

Medical devices in the UAE are classified according to their intended use and risk level. This classification influences the regulatory pathway, documentation requirements, and the approval process for medical devices seeking entry into the UAE market.

Key Requirements

To introduce medical devices into the UAE, manufacturers must:

  • Obtain pre-market approval from MOHAP, which involves submitting a comprehensive dossier that demonstrates the device's safety, quality, and efficacy.
  • Appoint a local Authorized Representative (AR) if they do not have a direct presence in the UAE. The AR is responsible for managing regulatory submissions and compliance on behalf of the manufacturer.
How We Can Help

Tailored Support for Market Entry

Our services streamline your regulatory journey in the UAE:

  • Assistance with product classification and identification of the appropriate regulatory pathway.

  • Preparation and submission of the necessary documentation for MOHAP approval.

  • Acting as your Authorized Representative in the UAE, handling regulatory submissions, and ensuring compliance with MOHAP's post-market surveillance requirements.

Frequently
Asked Questions

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We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

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