The United Arab Emirates is one of the most attractive healthcare markets in the Middle East: a high-income population, world-class hospitals, and a strategic position as a gateway to the wider GCC, Levant and Africa. But before any medicine, supplement or regulated health product can be sold, it must pass through product registration in the UAE. This guide gives international manufacturers a practical overview of how the process works and how to prepare.
Note: regulations and requirements change regularly. Always confirm current requirements directly with the Emirates Drug Establishment before submitting.
Who Regulates Healthcare Products in the UAE?
For many years, product registration was handled by the Ministry of Health and Prevention (MOHAP). In 2023 the UAE created a new federal regulator, the Emirates Drug Establishment (EDE), and responsibility for registering medical products has progressively moved to it. Today the EDE is the federal authority that grants marketing authorisation for medicines and medical devices, and its remit also covers products such as dietary supplements and cosmetics.
Local health authorities, such as the Department of Health in Abu Dhabi and the Dubai Health Authority, continue to regulate healthcare facilities and professionals within their emirates.
Step 1: Classify Your Product
The registration pathway, documents, fees and timelines depend on how your product is classified. Common categories include:
- Prescription and over-the-counter medicines (innovator or generic)
- Medical devices, including injectable devices such as hyaluronic acid products
- Dietary and health supplements
- Cosmetics and personal care products
- Herbal and complementary products
Borderline products – for example, a supplement with a medicinal claim or a cosmetic with a therapeutic ingredient – should be classified carefully at the start, as a wrong classification can cause long delays.
Step 2: Appoint a Local Representative
A foreign manufacturer without a UAE entity must work through a licensed local representative – typically a UAE-based pharmaceutical company or scientific office – that submits applications, communicates with the regulator and is responsible for the product locally. Choosing this partner is one of the most important decisions you will make, because they manage your registrations, supply chain and market relationships.
Step 3: Register the Manufacturer and Prepare the Dossier
For many product categories, the manufacturing site must be registered before individual products can be submitted. Product dossiers usually follow the international Common Technical Document (CTD) format. Documents commonly requested include:
- Letter of Authorisation (LOA) appointing the local representative
- Certificate of Pharmaceutical Product (CPP) or Free Sale Certificate from the country of origin
- Good Manufacturing Practice (GMP) certificate for the manufacturing site
- Product composition and specifications
- Certificates of Analysis for recent batches
- Stability studies supporting the proposed shelf life
- Product samples
- Artwork and labelling in Arabic and English
Official documents usually need to be legalised – for example, through the chamber of commerce and the UAE embassy in the country of origin. Allow time for this step.
Step 4: Submission, Evaluation and Approval
Applications are submitted electronically through the EDE’s online services. The regulator reviews the quality, safety and efficacy data, may request clarifications or samples for laboratory testing, and then issues marketing authorisation and pricing where applicable. Products already approved by recognised reference authorities, such as the US FDA or the European Medicines Agency, may be eligible for faster pathways.
Timelines vary widely by category. Cosmetics and supplements are often faster than new medicines, while a full pharmaceutical registration can take many months.
Common Pitfalls to Avoid
- Incomplete or inconsistent documents between the dossier, labels and certificates
- Documents that are expired or not properly legalised
- Labelling that does not meet local Arabic and English requirements
- Unclear product classification
- Choosing a partner without regulatory experience in your product category
Why the Right Local Partner Matters
A strong local partner does far more than file paperwork. They understand how the regulator works in practice, anticipate questions, keep registrations and renewals on track, and build the commercial channels – pharmacies, clinics and hospitals – that turn an approved product into a successful one.
With roots in the region since 1994, Vitabiohealth manages product registration and distribution for international pharmaceutical, supplement, orthopaedic and dermocosmetic brands in the UAE and Syria. Learn more about us.
Frequently Asked Questions
How long does product registration in the UAE take?
It depends on the product category and the completeness of the dossier. Cosmetics and supplements may take weeks to a few months; new medicines typically take considerably longer.
Can a foreign company register products directly?
Foreign manufacturers generally need a licensed UAE-based representative to submit and hold registrations on their behalf.
Does UAE registration cover other GCC countries?
No. Each GCC country has its own registration requirements, although a UAE registration and a strong local partner can support expansion across the region.
Ready to Enter the UAE Market?
If you are an international healthcare brand looking for a regional partner, we would be glad to discuss your products. Contact our partnerships team today.