UAE Medical Device Registration

Medical Device Registration in United Arab Emirates & Regulations

UAE Medical Device Registration is mandatory for all medical devices and in vitro diagnostic (IVD) products before they can be imported, distributed, or marketed in the United Arab Emirates. The Ministry of Health and Prevention (MOHAP) regulates medical devices under a centralized federal system. This guide provides a clear overview of the regulatory framework, product registration process, documentation requirements, timelines, and compliance obligations in the UAE.

» Regulatory Authority

The Ministry of Health and Prevention (MOHAP) is the federal regulatory authority responsible for:

Registration and listing of medical devices and IVDs
Licensing of local establishments (importers, distributors, warehouses)
Post-market surveillance and vigilance
Market control and regulatory inspections

MOHAP operates an electronic registration system for establishment licensing and medical device product registration.

Official Authority: Ministry of Health and Prevention (MOHAP)

» Link for Regulatory Authority

https://mohap.gov.ae/en/services/registration-of-a-medical-equipment

» Local Regulation

UAE Medical Devices Registration Guideline

» UAE Medical Device Regulations

Medical devices and IVDs in the UAE are regulated under MOHAP medical products regulations and executive guidelines. The UAE follows a reliance-based regulatory model, meaning MOHAP primarily depends on approvals from recognized reference regulatory authorities (such as EU CE marking or US FDA clearance) for product registration.

Key regulatory principles include:

Prior approval in a reference market
Appointment of a UAE Local Authorized Representative (LAR)
Establishment licensing before product registration
Post-market vigilance and adverse event reporting

» Medical Device Classification

Classification	Risk Level
Class I	Low risk
Class IIa	Medium risk
Class IIb	Medium risk
Class III	High risk

» Local Listing or Registration in UAE

To place a medical device or IVD on the UAE market, the product must be registered with the Ministry of Health and Prevention (MOHAP) through its electronic registration system. The process is summarized below:

The foreign manufacturer must appoint a UAE Local Authorized Representative (LAR) licensed by MOHAP.
The Local Authorized Representative must first complete establishment registration with MOHAP via the e-services portal.
The medical device or IVD must be classified according to MOHAP’s risk-based classification system, aligned with IMDRF principles (Class I, IIa, IIb, or III).
A medical device product registration application is submitted through the MOHAP online system, along with all required technical and regulatory documents.
MOHAP conducts a regulatory review of the submitted dossier, including verification of prior approvals (e.g., CE marking or US FDA clearance/approval).
If required, MOHAP may raise deficiency queries and request additional information or clarifications from the applicant.
Upon successful review, MOHAP issues a Medical Device Registration Certificate, allowing the product to be legally imported, distributed, and marketed in the UAE.
The registration certificate is typically valid for five (5) years and must be renewed before expiry to maintain market authorization.

Note: Only products registered with MOHAP can be legally imported and distributed in the UAE. All importers, distributors, and medical warehouses must hold valid MOHAP licenses.

» Documents Required for UAE Medical Device Registration

To register a medical device or IVD with the Ministry of Health and Prevention (MOHAP), the following documents are typically required. The exact set may vary depending on device class and risk category:

Application Form
Completed online through the MOHAP e-services portal by the Local Authorized Representative (LAR).
Manufacturer Information
Details of the legal manufacturer, including company profile and manufacturing site information.
Manufacturing Site License / Certificate
Valid manufacturing license or certificate issued by the competent authority in the country of origin.
Certificate of Free Sale (CFS) or Market Authorization Certificate
Issued by the competent authority in the country of origin, confirming the product is legally marketed in that jurisdiction.
Quality Management System Certificate (ISO 13485)
Valid ISO 13485 certificate covering the manufacturing site(s).
Proof of Conformity / Prior Approval
One of the following (as applicable):
- CE Certificate (European Union)
- US FDA 510(k) clearance or PMA approval
- Other recognized international regulatory approvals accepted by MOHAP
Device Classification Declaration
Risk classification of the device based on MOHAP’s risk-based classification system aligned with IMDRF principles, with classification rationale.
Product Description & Technical Information
Detailed description of the device including intended use, model numbers, variants, accessories, and technical specifications.
Instructions for Use (IFU) / User Manual
Latest version of IFU or user manual for the device.
Product Labels & Packaging Artwork
Inner and outer labels and packaging samples showing product name, manufacturer details, lot/serial number, and regulatory symbols.
(English is accepted; bilingual Arabic–English labeling is recommended for market compliance.)
Local Authorized Representative Agreement
Letter of appointment or agency agreement between the foreign manufacturer and the UAE Local Authorized Representative.
Post-Market Surveillance (PMS) / Vigilance Plan
Summary of the manufacturer’s system for complaint handling, adverse event reporting, and post-market monitoring.
Declaration of Conformity
Manufacturer’s declaration confirming compliance with applicable regulatory and quality requirements.

Note: MOHAP may request additional documents during the review process depending on the device type, technology, and risk class.

» Language Requirements

MOHAP accepts English documentation
Labels & IFU are recommended to include Arabic (not strictly enforced in all cases but highly advisable for compliance and market practice)

» Registration Timeline

Typical approval timelines range between 15–45 working days, depending on device class, dossier completeness, and MOHAP review workload.
Timelines may extend if additional information is requested.

» License Validity for UAE Medical Device Registration

Medical device registration certificates issued by MOHAP are valid for 5 years and are renewable.

» Who should make this Communication?

UAE Local Authorized Representative (LAR) / licensed importer or distributor
Foreign manufacturers submit through their appointed LAR (direct submission by overseas manufacturers is not permitted)

» When to make this Communication?

Before placing a medical device into the UAE market.

» Why Choose OMC Medical?

Proven expertise in MOHAP medical device and IVD registrations
Dedicated Local Authorized Representative support in the UAE
Cost-effective and transparent regulatory solutions
On-time project delivery with defined timelines
End-to-end regulatory support from pre-market to post-market compliance

Frequently Asked Questions

1. What is the process for UAE medical device registration?

Medical devices in the UAE must be registered with the Ministry of Health and Prevention (MOHAP). The process involves submitting a detailed application, classification, and compliance with UAE regulations.