Importing Pharmaceuticals and Medical Devices to the UAE: A Comprehensive Guide

With a focus on emerging as a global leader in healthcare, the UAE is rapidly developing its healthcare market. Presently, the country heavily relies on imported medical devices and pharmaceuticals. Its supportive infrastructure, strategic location, and conducive business environment make the UAE a regional trading hub for medical devices and pharmaceuticals.

This blog intends to guide you while importing pharmaceuticals and medical devices to the UAE. It gives a comprehensive picture of all processes involved, from registering your company in the UAE with the Ministry of Health to clearing your products at customs. 

Comprehensive Guide to Importing Pharmaceuticals and Medical Devices to the UAE: Regulatory Framework Governing Imports

The UAE’s regulatory framework for pharmaceuticals and medical devices recently replaced Federal Law No. 8 of 2019 with new Federal Law No. 38 of 2024. This new law took effect on January 2, 2025, and aims to improve the governance of pharmaceutical establishments, medical products, and pharmacy jobs in the UAE. 

Key authorities overseeing the medical equipment and pharma goods clearance during import are: 

• Ministry of Health and Prevention (MOHAP)—the federal ministry overseeing healthcare policy in the UAE
• Department of Health Abu Dhabi (DOH)—the primary regulatory authority in Abu Dhabi
• Dubai Health Authority (DHA)—the regulatory body regulating medical equipment and healthcare activities, including pharmaceuticals, within the Emirate of Dubai.

Comprehensive Guide to Importing Pharmaceuticals and Medical Devices to the UAE: Licensing Requirements for Importers

To import pharmaceuticals and medical devices into the UAE:

• UAE companies (even those with a part of foreign shareholding) require a medical warehouse license to import medical devices and pharmaceuticals. 
• UAE citizens require a medical importer license. 

Also read: Warehouse Safety and Security: Top Technologies and Practices

Marketing Authorization Process:

• Marketing authorization holder companies, marketing consultants, and distributors, along with entities and individuals involved in the purchasing, enlisting, prescription, dispensing, and reimbursement of medical products, should get marketing authorization approval from the Ministry of Health and Prevention (MoHAP).
• Products can only be imported by the local agent cited in the approval for the product’s marketing authorization 

Required Document:

• A valid certificate of free registration or sale certified by the UAE Embassy and issued by competent authorities in the country of origin.
• Product agency contract’s copy signed between the agent and the company. 

Comprehensive Guide to Importing Pharmaceuticals and Medical Devices to the UAE: Medical Equipment and Pharma Goods Clearance Process

The process of obtaining import permits for medical devices and pharmaceuticals includes the following steps:

• Register your company in the UAE (with you as a shareholder) with the Ministry of Health and Prevention (MoHAP).
• Get a trade license that permits activities related to the importation of medical devices and pharmaceuticals. 
• As per Article 47 of the Pharmacy Law, get a license for your medical warehouse in the UAE. 
• Register the medical devices and pharmaceuticals you want to import with MoHAP.
• Gather all necessary documents for MOHAP medical equipment registration.
• Complete payments and submission of your request using a smart app or the MoHAP website.
• Your registration application will be reviewed by a competent technical committee.
• Once approved, you will receive a certificate of registration with a validity of 5 years.

Comprehensive Guide to Importing Pharmaceuticals and Medical Devices to the UAE: MoHAP Medical Equipment Registration and Compliance with UAE Standards

MoHAP medical equipment registration and compliance with UAE standards include the following steps:

• Obtaining a pre-market approval before you introduce medical devices into the market in the UAE
• Appointing a local authorized representative (AR) to guarantee compliance with UAE regulations and act as your point of contact with MoHAP.
• Submission of a comprehensive dossier explaining the device’s quality, safety, and efficacy.

Comprehensive Guide to Importing Pharmaceuticals and Medical Devices to the UAE: Distribution and Marketing Regulations in the UAE

The regulatory framework for the distribution and marketing of medicines and medical devices in the UAE includes:

• Federal Decree-Law No. 38 of 2024:

This law replaces Federal Law No. 8 of 2019 and regulates the pharmacy profession, medical products, and pharmaceutical establishments.

• Emirates Drug Establishment (EDE):

The EDE manages and regulates medical products, including healthcare products, pharmaceuticals, medical devices, biologics, and more. 

• Ministry of Health and Prevention (MOHAP):

MOHAP manages the registration and control of drugs and medical devices. As per the medical device distribution laws in the UAE, you should register all medical devices meant for import, sale, or distribution with the MoHAP. This registration guarantees the quality, safety, and efficacy of the devices.

Importing Pharmaceuticals and Medical Devices to the UAE: Post-Market Surveillance and Quality Control 

• Reporting safety concerns and adverse events to UAE health authorities:

Healthcare companies and professionals can use the MoHAP website or smart app to submit reports, which will be sent to the World Health Organization (WHO).

MoHAP’s system for post-market surveillance of imported pharmaceuticals and medical devices.

• MoHAP, with the Drug Control Department (DCD), controls medical devices, including post-market surveillance. 

The post-market surveillance activities controlled by these regulatory bodies include:

• Monitoring Safety and Performance
• Collecting Data
• Addressing Issues
• Reporting
• Corrective Actions
• Field Safety Corrective Actions (FSCA)
• Data Analysis
• Compliance with Regulations
• Procedures for product recalls and corrective actions.

The Department of Health Abu Dhabi (DOH) manages product recalls and corrective actions for medical devices and medicines in the UAE. 

Challenges and Best Practices for Importers 

The following are the common challenges in medical equipment and pharma goods clearance in UAE ports.

• Regulatory Complexity
• Product Registration
• Marketing Authorization
• Local Ownership Requirements
• Supply Chain Security
• Counterfeit Products

Further, the following are a few strategies that help in faster approvals and seamless regulatory compliance: 

• Establish a UAE Company
• Obtain Necessary Licenses
• Product Registration
• Compliance with Standards
• Partner with Local Experts
• Ensure Quality and Safety
• Utilizing  fast-track approval pathways
• Considering free zone transit in
• Following the UAE’s zero-tolerance policy
• Staying updated on regulatory changes

Conclusion: 

Importing pharmaceuticals and medical devices to the UAE requires you to include a company there and apply for its registration with the Ministry of Health. You can also engage a local distributor or local agent already registered with the Ministry for the importation process. Though these processes may seem daunting, a company like Ryan Worldwide, which is engaged in customs clearance in Dubai, UAE, can help.

We can expedite the entry of your medical products into the UAE by providing expert guidance and streamlining the import process. We can handle the necessary paperwork and ensure the importation process complies with all required regulations. To know more about our services or for inquiries on the importation of medical products to the UAE, contact us at:

• Phone: +9714 2528468 or +971559020985
• Email ID: info@ryan-worldwide.com.

Also read: How to Calculate Import Duty and VAT in UAE: A Comprehensive Guide