In Dubai’s bustling healthcare and cosmetics industry, the demand for state-of-the-art medical gadgets and captivating beauty products is skyrocketing. However, thriving in this dynamic market comes with a set of strict rules that every business must follow.
Our comprehensive guide is your trusted companion for smoothly navigating the process of registering cosmetic devices in Dubai. We’re here to make compliance easy, whether you’re a seasoned healthcare professional or a budding beauty entrepreneur.
Dubai’s charm lies not only in its vibrant business scene but also in its commitment to ensuring the safety and effectiveness of every cosmetic device reaching consumers. Read on as we explore the steps, keeping you informed and empowered. Together, we’ll embark on the path to compliance and excellence.
Table of Contents
What is Cosmetics Device Registration?
Cosmetics device registration is a vital process that empowers the Consumer Products Safety Section (CPSS) to evaluate the effectiveness and safety of cosmetic devices when applied to exposed body parts such as nails, hair, or skin. It ensures that these devices meet the required standards for consumer safety and effectiveness.
However, it’s important to note that no cosmetic device can be distributed, manufactured, imported, advertised, exported, or sold in Dubai without the proper registration. This registration is a legal requirement, serving as a shield to protect consumers.
Furthermore, it’s essential to keep in mind that the registration of cosmetic devices in Dubai is valid for a specific duration, typically five years. After this period, it may need to be renewed to continue compliance with regulatory standards.
Key Features of Cosmetics Device Registration
From the day the product registration certificate is issued, the registered device is valid for 5 years. The cosmetic device will be assessed once the validity term has passed before a government-approved device renewal of registration.
Here are the key features of registering a cosmetic device:
- Before selling in the local market, cosmetic devices must be registered with the authorities. Without Cosmetic Device Registration, distributing in the market is impossible.
- Any businessman who plans to sell, make, import, or distribute a cosmetic device must register it on its own. The availability of a valid trade or industrial license with a linked activity in the United Arab Emirates is required for device registration. Plus, the registration validity is on a company level.
- The device needs to fulfill the suggested health and safety requirements listed in the Consumer Products Safety Section (CPSS). The Product Registration Certificate is only then issued to the company.
- If the device is rejected for registration, a Product Assessment Report is generated and the device is labeled as an unapproved device. It cannot be sold in the local market until it gets approved by the authorities.
Advantages of Cosmetic Device Registration in Dubai
The following benefits make cosmetic device registration in Dubai a strategic choice for businesses looking to thrive in the UAE’s cosmetics industry:
- You can expect complete assistance from the government of Dubai, making the registration process more straightforward, quick, and efficient.
- It allows for smooth international trade and shipping beyond the borders of the UAE, making it easier to reach a global market.
- Dubai offers tax-free or very low-tax business opportunities, creating a favorable financial environment for your cosmetic device business.
- Cosmetic device registration protects your product’s label and brand, ensuring that your intellectual property is protected.
- Device registration grants you the rights to import, manufacture, and re-export cosmetic devices, expanding your business opportunities.
- Dubai serves as a gateway to not only the UAE but also other lucrative Gulf countries, providing access to profitable markets in the region.
Required Documents for Cosmetic Device Registration
The following documents are needed for cosmetic device registration in Dubai:
- Certification of incorporation
- An organic certificate, Halal certificate, or any further supporting documentation
- Report about tests conducted at a lab (if applicable)
- Free Sales Certificate
- Certificate of Analysis
- The analysis report for the device
- Picture of the device
- Ingredients Report or the list of ingredients in a product
- GMP (Good Manufacturing Practice) certificate
- Certificate of Free Sale
- Clear artwork of the device
Label Requirements for Cosmetic Device Registration
When it comes to registering cosmetic devices, adhering to label requirements is crucial. Every cosmetic device must have a label on its packaging. Typically, this label is expected to be in English, although it can also be bilingual or multilingual. The key is that the content must be exactly the same in all languages used.
The essential information that should be included on the cosmetic device label comprises:
- Country of Origin
- Device Name
- Brand Name
- Manufacturer Information
- Usage Instructions
- Nutritional Information (if applicable)
- Storage Conditions
- Declaration of any ingredients that may cause hypersensitivity or require special usage instructions
- Clear mention of the production and expiration dates
- Net volume or weight
- Ingredients Information
- Device Barcode
How to Register a Cosmetic Device in Dubai?
Registering a cosmetic device in Dubai involves a series of steps. By following the following steps, you can successfully register your cosmetic device in Dubai, allowing you to legally produce, import, export, advertise, sell, and distribute it in the market. The steps that you need to follow are given below:
1. Establish a Registered Company
Having a registered company is a fundamental requirement for cosmetic device registration in Dubai. Only a UAE-based company with a valid trade license, particularly in the field of cosmetic devices, is eligible to apply for registration.
This license can be one for a free zone in one of the seven emirates or a license for the Dubai mainland. The only requirements are that the license be current and that the business activity corresponds to the device you want to register with Dubai Municipality.
2. Gather Required Documents
Ensure that you have the necessary documents, including a Certificate of Free Sales (CFS) issued by the health authority or a recognized body from the country of origin. You’ll also need to provide a laboratory test report from either the Dubai Central Laboratory or the country of origin.
Additionally, provide a comprehensive Data Analysis report, which should cover the device ingredients, physical properties, and chemical composition. We have mentioned the rest of the important required documents above.
3. Fill Out the Product Registration Form
Get the official product registration form from the Dubai Municipality office. Complete the form, following the technical instructions provided by the e-form program.
You can also do it online. To do so,
- Create an online account on the Dubai Municipality Portal and wait for its activation. After it is activated, you need to ask for the services for product registration according to the category of your device, in this case, cosmetic device.
- Create an online application through the Montaji portal with the necessary device information and upload the relevant documentation in accordance with Dubai Municipality regulations.
- Once all the necessary files have been uploaded and everything is ready, submit the application, pay the fee, and then wait for a response from their side.
4. Request a Label Evaluation
Your cosmetic device may require a label evaluation. Submit the device label design slip and the necessary application details to the Consumer Products Safety Section (CPSS). CPSS may also need a sample of the device. We have already mentioned the label requirements that should be fulfilled.
5. Cosmetic Label Assessment Report
Once CPSS reviews the label, they will issue a Cosmetic Label Assessment Report. This report includes vital device information and any suggested modifications to meet regulatory requirements.
6. Device Labeling
It’s crucial to ensure that the labeling of your cosmetic device complies with the mandatory information standards. This step may involve the distributor, manufacturer, supplier, importer, or retailer, depending on the responsible party.
7. Review and Certification
After a thorough review of all submitted documents and assessments, the Dubai Municipality office will issue the original certificate for your registered cosmetic device.
Why is it Required to Register a Cosmetic Device in Dubai?
The Dubai Municipality conducted an investigation. It revealed that many cosmetic products contain harmful ingredients. Additionally, it was discovered that roughly 25% arsenic, 30% lead, and 20% chromium were intermingled in nearly 3000 cosmetic products.
So, before a product could hit the market, the DM mandated that it must adhere to the registration requirements. There were some other reasons as well which include:
- Preserving the device’s quality and guaranteeing user safety
- Limiting the sale of dangerous and artificial devices in the local market
Cosmetic Devices that RIZ & MONA CONSULTANCY Registers in Dubai
Here are the cosmetic devices that we can register in Dubai:
- Dermal Fillers: Dermal fillers are injectable substances used to restore volume and fullness to the face, reducing the appearance of wrinkles and fine lines. They are often made from materials like hyaluronic acid and are administered by medical experts.
- Advanced Laser Equipment: Advanced laser equipment includes a range of medical lasers used in dermatology and cosmetic procedures. These lasers can treat various skin conditions, remove unwanted hair, and improve skin texture and tone.
- Microdermabrasion Machine: A microdermabrasion machine is a device that exfoliates the skin’s outer layer, reducing the appearance of fine lines, acne scars, and sun damage. It’s a non-invasive treatment for achieving smoother, rejuvenated skin.
- Injectable Tools: Injectable tools, such as syringes and needles, are used to administer various injectable treatments like Botox or dermal fillers. They require precision and are typically used by medical professionals.
- Micro-Needling Device: Micro-needling devices use fine needles to create tiny, controlled injuries in the skin. This stimulates collagen production and can improve the appearance of scars, wrinkles, and skin texture.
- Skin Analysis Devices: Skin analysis devices use technology like UV light or specialized cameras to assess skin conditions and concerns. They provide a detailed analysis that helps skincare professionals tailor treatments and skincare regimens to individual needs.
- Facial Steamers: Facial steamers are used in skincare routines to open pores, cleanse the skin, and prepare it for various treatments. They provide a relaxing and rejuvenating experience while promoting healthy skin.
- Magnifying Lamp: A magnifying lamp is a tool equipped with a magnifying lens and a light source. It’s commonly used by dermatologists and estheticians to closely examine the skin’s surface, making it easier to identify skin issues and imperfections.
- IPL Device: Intense Pulsed Light (IPL) devices emit broad-spectrum light that can target various skin concerns, including pigmentation, hair removal, and vascular issues. They offer non-invasive treatments for various skin conditions.
You can contact us to register these cosmetics and medical devices in Dubai and start your business right away. We have experienced professionals who can not only guide you through the process but also can help you with registration. We can also register your products on your behalf without giving you the hassle of doing it on your own.
Cosmetic Device Registration in Dubai with RIZ & MONA
The UAE has witnessed a substantial surge in the demand for medical equipment and cosmetics in the past few years. In this ever-evolving healthcare and beauty landscape, the urgent need for both healthcare and cosmetic devices in the UAE has prompted a significant increase in imports. However, it’s imperative to recognize that distributors, importers, or manufacturers of medical and cosmetic devices must adhere to a mandatory product registration process in the UAE before introducing their products to the market.
Following the crucial steps involved in the UAE’s cosmetics device registration can be a formidable task, especially for foreign investors. This is precisely where the expertise of product registration consultants becomes absolutely important. RIZ & MONA CONSULTANCY, a reputable product registration firm in the UAE, is your dedicated partner in simplifying the registration process for cosmetic devices in Dubai.
Serving as a trusted local representative, We are committed to assisting companies in fulfilling all regulatory requirements while keeping associated costs to a minimum. With a wealth of legal knowledge and industry experience, our team is well-equipped to guide businesses through the process of registering their clinical and cosmetic devices with the UAE Ministry of Health and Prevention (MOHAP). For more information, contact us today.
FAQs – Frequently Asked Questions
What are the labeling requirements for cosmetic devices in Dubai?
Cosmetic device registration in Dubai necessitates specific labeling, including information such as:
- Country of origin
- Device name
- Brand name
- Manufacturer Details
- Usage instructions, and more.
What documents are needed for cosmetic device registration in Dubai?
To complete Cosmetic device registration in Dubai, you’ll need crucial documents, including:
- Certification of incorporation
- Lab test reports
- Free Sales Certificate
- Certificate of Analysis
- GMP certificate, and more.
What's the validity of cosmetic device registration in Dubai?
- Cosmetic device registration in Dubai is typically valid for five years.
- Renewal is possible after this period to maintain compliance.
Why is cosmetic device registration crucial in Dubai?
- Cosmetic device registration ensures safety and quality standards.
- It’s a legal requirement in Dubai to protect consumers.
How can foreign investors register cosmetic devices in Dubai?
Foreign investors looking to complete Cosmetic device registration in Dubai should follow these steps:
- Establish a registered company
- Gather the required documents
- Fill out the product registration form
- Ensure compliance with label requirements.
Professional consultants play a crucial role in simplifying the registration process and providing expert guidance.
What advantages does Dubai's cosmetic device registration offer businesses?
Cosmetic device registration provides numerous advantages, including:
- Government assistance
- Access to international markets
- Favorable tax environments
- Brand protection
- Access to the Gulf region.
It’s mandatory to ensure consumer safety, prevent substandard product sales, and maintain industry quality.
How does RIZ & MONA CONSULTANCY assist with cosmetic device registration in Dubai?
RIZ & MONA CONSULTANCY serves as a trusted local representative, simplifying the Cosmetic device registration process for businesses.
Are dermal fillers considered medical devices in Dubai?
Dermal fillers are indeed classified as medical devices in Dubai. Here’s what you need to know about their registration:
- Registration is mandatory for dermal fillers in Dubai.
- Businesses must provide documentation confirming compliance with safety and quality standards.
What are the registration requirements for advanced laser equipment in Dubai?
When it comes to registering advanced laser equipment in Dubai, it’s essential to follow these guidelines:
- Ensure that your advanced laser equipment meets safety and quality standards.
- Submit the necessary documentation to prove compliance.
How can I register a microdermabrasion machine in Dubai?
Registering a microdermabrasion machine in Dubai involves the following steps:
- Verify that your microdermabrasion machine complies with safety regulations.
- Submit the required documents to support your registration application.
What steps are involved in registering injectable tools in Dubai?
Registering injectable tools in Dubai is a structured process:
- Ensure your injectable tools meet specific safety and quality criteria.
- Prepare and submit the necessary documents for verification.
Is registration needed for micro-needling devices in Dubai, and what are the steps?
Yes, registration is mandatory for micro-needling devices in Dubai. Here’s a breakdown of the process:
- Confirm your device’s compliance with safety standards.
- Complete document submission for registration purposes.
How can I register skin analysis devices in Dubai?
Registering skin analysis devices in Dubai involves these steps:
- Verify that your device meets safety and quality standards.
- Compile and submit the necessary documentation for evaluation.
Are there specific registration requirements for facial steamers in Dubai?
Facial steamers must adhere to these registration criteria in Dubai:
- Comply with safety and quality regulations.
- Submit documentation supporting your registration application.
What are the necessary steps for registering magnifying lamps in Dubai?
Registering magnifying lamps in Dubai follows these guidelines:
- Ensure that your magnifying lamps meet safety and quality standards.
- Prepare and submit the required safety documents for assessment.
Can you explain the registration process for IPL devices in Dubai?
Registering IPL devices in Dubai requires careful consideration of safety and quality compliance. Here’s what you need to do:
- Confirm that your IPL device meets specific safety and quality standards.
- Compile and submit the necessary documentation for the registration process.