The United Arab Emirates is a significant healthcare and medical technology hub. This development created lucrative business opportunities globally to import and export medical products to this thriving market. However, navigating the regulatory landscape of this market is complex and challenging.
How to Successfully Import and Export Medical Products to and from the UAE
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Establish a Legal Entity
- Register Your Company- The first step is to establish a legal business entity in the UAE, such as a Limited Liability Company (LLC) or a Free Zone company.
- Obtain MOHAP Approval- Your company must be registered with the Ministry of Health and Prevention (MOHAP) to obtain a license for importing and distributing medical products. Local agents with valid medical store licenses can obtain necessary permits.
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Product Registration and Approval
- Product Classification- MOHAP classifies medical products based on their risk level.
- Detailed Product Information- Manufacturing processes, testing procedures, and packaging information are important to gain approval.
- Adherence to International Standards- Your products MUST comply with international quality standards like ISO 13485 for medical devices and GMP for pharmaceuticals.
- Labeling and Packaging- Adhering to MOHAP’s specific guidelines, including the use of Arabic language is a MUST.
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Get Necessary Licenses
- You must acquire an import license from MOHAP for every product you plan to import.
- When exporting from the UAE, particularly controlled substances, securing an export license is crucial for compliance and success.
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Customs Clearance
- Follow the UAE Customs Authority’s rules and regulations for customs clearance.
- Provide all the necessary documentation for smooth customs clearance.
- Pay applicable import duties and taxes.
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Storage and Distribution
- Good Storage Practices: Store your products in licensed warehouses that meet MOHAP’s standards to maintain their safety and efficacy.
Partnering with a Reliable Local Expert
Partnering with a knowledgeable local agent or distributor is highly recommended to streamline the import/export process and ensure compliance with UAE regulations. Wellcomet Middle East, a trusted name in the UAE healthcare industry, offers comprehensive services to assist businesses in navigating the market’s complexities.
Why Wellcomet Middle East?
- We are licensed. Our team of experts stays updated on the latest regulatory changes to ensure compliance.
- Efficient Product Registration and Approval. We expedite the product registration process to minimize time-to-market.
- Reliable Storage and Distribution: Our state-of-the-art warehouses ensure the safety and integrity of your products.
With Wellcomet ME, you are confident in achieving your business goals with our extensive expertise and strong network. Contact us today to learn more about how we can assist you.
Great article! A clear and informative guide on medical product import and export in the UAE. Very helpful for businesses in the field!