Companies need to determine the regulatory classification and applicable requirements for a product before bringing it into the UAE market. The Emirates Drug Establishment (EDE) provides a product classification service covering products of different types and forms based on factors such as presentation, composition, use, and design. If the classification determines that EDE marketing authorisation is required, the product must subsequently be registered with EDE according to the category specified in the classification letter.
The UAE regulatory authority has its official procedures to follow for product classification. This blog helps us understand it along with the requirements and considerations.
EDE Product Classification in the UAE
Applicants can submit a product classification application to the Emirates Drug Establishment (EDE) to determine the applicable regulatory category for their product. EDE evaluates the product based on factors such as its presentation, composition, intended use, and design. The current service completion time is 10 working days, subject to the requirements of the application and any additional information requested by the authority.
Key Components of the Product Classification Process in UAE
The current EDE service says that the classification letter has the following:
- Informs the applicant of the laws governing the product
- Determines the regulatory category
- Decides the need for EDE marketing authorisation
Distinction Between Product Classification and Registration
It is important to distinguish product classification from product registration. Classification determines the applicable regulatory category and whether EDE marketing authorisation is required; it does not itself constitute marketing authorisation or approval to market the product in the UAE. The classification service is available to companies and individuals, while subsequent registration requirements depend on the regulatory category assigned to the product.
Product classification should therefore not be treated as marketing authorisation. It establishes the applicable regulatory pathway; any required product registration must be completed separately according to the classification outcome.
Documentation Requirements for Product Classification in the UAE
To initiate the regulatory classification process, certain documents must be submitted, including the ones mentioned below:
Mandatory Documents
The required documents are as follows:
- Emirates ID or Passport or Trade License or Drug Store License (Depending on the user type)
- Certificate from the Country Of Origin Authority Related To The Product (CPP/Free Sale Certificate/CE/ISO)
- Product Photo
- Leaflet/Product Information in English/Arabic
Optional Documents
The following documents are optional:
- Inner and outer pack label with clear and readable product information (artwork)
- Composition Certificate or Material Safety Data Sheet (MSDS)
- Registration and Marketing Status in Other Countries
- Product Catalogue for Medical Devices
Additional Requirements for Medical Devices Product Classification in UAE
Medical devices may require additional classification considerations based on their accessories, sizes, configurations, intended uses, kits, and related components. The EDE classification guidance sets out specific requirements for these cases.
All these points are discussed below:
Accessory Identification
For devices with numerous accessories, a comprehensive table listing accessory names and codes, if applicable, must be provided. The list should be prepared on the manufacturer’s letterhead and carry the manufacturer and local distributor stamps. If the list extends over multiple pages, each page should be stamped accordingly.
Size Variation
Products with multiple sizes can be submitted under one application. However, variations in models, configurations, uses, or dosage forms are treated as distinct applications.
Treatment of Devices and Accessories
Each device and its accessories are treated as a single product for classification purposes, with corresponding fees applied accordingly.
Differentiating Supporting Items
Supporting items targeting different areas of the body or functions of the device are considered separate products, subject to applicable fees.
First Aid Kits Classification
Individual items within first aid bags and kits are classified separately, with associated fees applied accordingly.
Classification of Dentistry Kits
Dentistry kits are classified based on their components. Tools and equipment within the same group are classified together, while products containing pharmaceutical and chemical substances are treated as separate applications.
Laboratory Reagents Handling
Reagents linked to specific systems/analysers are treated as a single application, while separate individual reagents or rapid test kits require separate applications.
EDE Product Classification Application Submission Process in the UAE
Applicants can access the EDE Product Classification service through the EDE portal using UAE PASS. The application process involves creating a new application, selecting Product Classification, completing the product details, uploading the required attachments, reviewing the application, accepting the applicable terms and conditions, and submitting the application. The applicant is then directed to checkout to pay the applicable fee of AED 500 per application, made through EDE’s payment gateway.
EDE Product Classification Application Review Process in the UAE
Here’s how the applications are reviewed by EDE:
1. Application Correction
If an EDE officer identifies fields or attachments that require modification, the application may be returned to the applicant for correction as part of the Product Classification review process. The applicant will have access to modify only the relevant section requiring updates, while other sections will be deemed final and subsequently locked against further changes.
2. Sample Request
EDE officers may seek further clarification or request the submission of product samples to conduct a more thorough evaluation of the product under consideration. The applicant is responsible for shipping the samples to EDE and providing the sample shipment details via the portal application. These details must include the name of the courier company, tracking number, and date of shipment.
3. Appointment Request
The officer may seek additional discussions or consultations regarding the application and propose an appointment with a suggested schedule. This process fosters direct communication between applicants and EDE officers, improving clarity and addressing any enquiries or concerns. The applicant has the option to either accept the proposed schedule or propose an alternative date and time.
4. Analysis Request
As part of the Product Classification review, an EDE officer may request an analysis of a medical product. Where an analysis is requested, the EDE External User Guide specifies an analysis fee of AED 3,000 and a certificate fee of AED 500. During the analysis evaluation, the applicant may also be asked to provide corrections, submit a sample, or attend an appointment, as applicable.
5. Product Classification Letter
Once an application has been thoroughly reviewed and approved by an EDE officer, the applicant is issued a Product Classification Certificate. The Product Classification Letter issued includes the following particulars:
- Application Number
- Date of Issue
- Expiry Date
- Name of Applicant, along with City and Country
- Committee M. No., along with the Date
- Name and Form of the Product
- Manufacturer’s Name and Country
- Classification Assigned
Timelines, Fees, and Validity
EDE strives to ensure efficiency in its processes, aiming for a turnaround time of 10 working days for product classification requests. The associated fee for product classification is AED 500. The Product Classification Letter includes an expiry date. Applicants should refer to the validity stated on the issued classification letter and the latest EDE requirements.
Conclusion
Product classification is an important step in determining the regulatory pathway for products intended for the UAE market. The EDE Product Classification service allows companies and individuals to determine the applicable regulatory category based on the product’s presentation, composition, use, and design.
The classification process is completed through the EDE portal, where applicants can submit product information and supporting documents, respond to any required corrections or requests, and complete the applicable payment. Where the classification determines that EDE marketing authorisation is required, the product must subsequently be registered with EDE according to the category specified in the classification letter.
So, if you need regulatory assistance for your product in the UAE, partner with Artixio to make your product journey successful. Artixio has well-experienced and trained local professionals working in the region with expertise in regulatory compliance, who aim to help throughout your product journey. So, contact us today at info@artixio.com.
FAQs
What is the validity period of the EDE classification certificate?
The Product Classification Letter issued by EDE contains an expiry date. Applicants should refer to the expiry date stated on their issued classification letter and the latest EDE requirements.
Can multiple product sizes or pack sizes be included in an EDE classification application?
Yes. Where applicable, applicants can provide information about multiple product sizes or pack sizes as part of the Product Classification application. The EDE user guide provides for a specific attachment listing product sizes, pack sizes, accessories, or kit components.
Do I need a localised agent in the UAE for classification application submission to EDE?
The target audience for medical product classification is medical warehouses, pharmaceutical manufacturers, local facilities, and individuals.
What is the role of UAE PASS in the EDE product classification application?
UAE PASS is used to log in to the EDE portal and access the relevant services. The EDE user-management guide describes the UAE PASS login and account-linking process for accessing the Drug Registration System through the EDE portal.
