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.
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.
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
What is the primary regulatory authority for medical device registration in the UAE?
The primary regulatory authority for medical device registration in the UAE is the Ministry of Health and Prevention (MOHAP UAE). Pure Global can assist with navigating the registration process to ensure MOHAP approval for selling medical devices in the Emirati market.
How are medical devices classified in the UAE?
Medical devices in the UAE are classified based on their intended use and associated risk level. This classification determines the regulatory pathway, documentation requirements, and the approval process for UAE medical device registration, enabling devices to enter the UAE market.
What are the key requirements for foreign manufacturers to market medical devices in the UAE?
Foreign manufacturers must: Obtain pre-market approval for UAE medical device registration from MOHAP by 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 manages regulatory submissions and ensures compliance with UAE regulations on behalf of the manufacturer.
Why is appointing a local Authorized Representative (AR) important for foreign manufacturers in the UAE?
Appointing a local Authorized Representative (AR) is essential because the AR acts as the local point of contact with MOHAP and manages all regulatory affairs on behalf of the manufacturer. The AR ensures that regulatory submissions are accurate and complete, facilitates communication with authorities, and ensures ongoing compliance with United Arab Emirates medical device regulations, thereby enabling market access and business continuity for medical devices in the UAE.
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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.