Any dental or surgical equipment that has to be used in the UAE must be registered before it can be used or even sold. The process is overseen by the Ministry of Health and Prevention in the Emirates and demands some documentation along with a few requirements to be met. This guide will give you an overview of dental/surgical equipment registration in the UAE so that you can complete the process without facing any issues.
Dental/Surgical Equipment Registration in the UAE – Complete Process
The following process must be completed so that your dental/surgical equipment can be legally registered and utilized in the UAE market. If you have any questions or need assistance at any step of the process, don’t hesitate to reach out to professional medical product registration companies like RIZ & MONA CONSULTANCY for guidance and support.
- First, log in to the Ministry of Health and Prevention (MoHAP) website or use the smart app with your UAE PASS.
- Then, submit your registration request through the electronic service and ensure that all necessary payments are completed to meet the specified conditions.
- Your request for registering your dental or surgical equipment will be reviewed by the competent technical committees. Their recommendations will then be forwarded to the relevant ministerial committee for further consideration.
- Next, you will receive official letters from the concerned authorities regarding the decisions made by the committee.
- You need to follow up with the Analysis Section of the Drug Department to stay updated on the progress of your medical product registration application.
- You must make sure that your company fulfills all requirements and submit them electronically through the designated service.
- If any medical products were deferred during the initial deliberation, the technical and ministerial committees will reassess them once all requirements are met.
- Once approved, registration certificates for the dental or surgical products will be issued. These certificates are valid for five years from the date of the committee’s approval, provided all conditions and requirements are satisfied.
The process takes about 45 days to be completed and can be done either by the MOHAP website or the MOHAP smart application.
When considering product registration in Dubai, it’s crucial to adhere to the regulations set forth by the Ministry of Health and Prevention to ensure compliance and facilitate market entry.
Required Documents
You must check that all the following necessary documents are provided. You also need to meet the specified requirements will facilitate a smooth and efficient registration process for your dental/surgical equipment in the UAE.
- A copy of the product agency contract signed between the company and its agent.
- Certificates of quality conformity/marketing authorization, such as 510 K (Premarket Notification), PMA (Parts Manufacturer Approval), and EC (European Conformity), based on the equipment classification (Class I, II, III, IV).
- Completed application form for registration, duly filled, signed, and stamped by the company.
- Safety and efficacy data (for products classified as Class III, IV).
- A copy of the valid registration certificate of the factory.
- A valid certificate of free sale or registration provided by the competent authorities in the country of origin, authenticated by the Embassy of the United Arab Emirates.
- Post-marketing monitoring requirements.
- Company acknowledgment of equipment conformity to the specifications outlined in the Medical Equipment Manual (EC (European Conformity) – Declaration of Conformity).
- Detailed product information, including sizes, models, description, formulation, types, accessories, contraindications, warnings, usages, side effects, precautions, usage guidelines, and photographs of brochures, packaging covers, and usage manuals.
- Laboratory analysis and requirements, along with pricing for specific medical equipment.
- Provision of one sample, certificate of analysis (as per equipment type), brochures, and external and internal covers.
- Certificate of conformity to surgical or dental equipment manufactured from animal products.
Conditions & Requirements
The following conditions and requirements must be met in order to register surgical or dental equipment in Dubai, UAE:
- Marketing Authorization Holder (MAH) companies must be registered with the Ministry of Health and Prevention (MOHAP) before initiating the registration process for their dental or surgical equipment products.
- The medical warehouse or marketing office associated with the MAH company must hold a valid license issued by the Ministry of Health to operate legally in the UAE.
What activities can you conduct Once Your Surgical or Dental Equipment is Registered?
Once your surgical or dental equipment is registered, you can engage in various activities related to importing and trading medical instruments, devices, or equipment in Dubai. Here are some of the activities permitted by the Department of Economic Development:
Surgical, Medical Articles, and Requisites Trading
This category allows for the importation and trading of a wide range of instruments and precise medical items used for treating specific diseases. Examples include
- Walking sticks
- Earphones for hearing aids
- Pulse regulators
- Medical shoes
- Batteries for cardiac patients
- Splints for bone fractures, and more
For a comprehensive list of specific activities permitted under this category, feel free to contact us during the registration process.
Surgical Instruments and Medical Equipment Trading
This category includes the reselling and importation of medical equipment and instruments used in hospitals, clinics, and other medical healthcare centers for various purposes such as
- Treatment
- Diagnosis
- Blood preservation
- Sterilization
- Surgical operations, and more
Under this category of medical device registration, you can engage in trading activities related to a broad spectrum of medical equipment and instruments essential for healthcare facilities.
Benefits of Registering Surgical or Dental Equipment in Dubai
Registering surgical or dental equipment in Dubai offers numerous advantages in the thriving healthcare market of the UAE.
With the UAE’s medical expenditure projected to rise to 4.6% of its GDP by 2026, and medical care spending estimated to reach 126 billion dirhams ($34 billion) by 2027, the market presents significant growth potential. Much of this growth stems from increasing demand for preventive and specialist care, highlighting a sustained interest in healthcare and medical services.
Furthermore, with the government’s implementation of business-friendly policies and liberalization of import regulations for foreign investors, now is an ideal moment to establish a medical company in the region.
Amid the global pandemic, there’s a heightened need for dental, surgical, and other medical equipment to support and aid medical professionals in the UAE. This increased demand underscores the importance and opportunity for foreign entrepreneurs and investors to obtain a medical trading license and venture into the medical equipment trading business in the UAE.
Moreover, The UAE prioritizes providing top-notch medical treatment to its residents, featuring world-class medical services. To maintain these high standards, healthcare professionals rely on high-quality medical equipment to deliver exceptional care.
With favorable business conditions, growing demand, and a commitment to excellence in healthcare, registering surgical or dental equipment in Dubai presents a promising prospect for those looking to enter the healthcare industry in the region.
Who Needs to Register Dental/Surgical Equipment in the UAE?
Registering your medical devices with the MoHAP guarantees the safe and efficient distribution of essential medical equipment across the country. The following business entities must register their surgical or dental equipment in the UAE:
Medical Warehouses
If you run a medical warehouse for importing or trading surgical/dental equipment in the Emirates, you should register these medical devices. Medical warehouses play a crucial role in the distribution and storage of dental and surgical equipment within the UAE healthcare system. These entities are responsible for maintaining the shape and quality of medical supplies before they reach healthcare facilities.
Local Pharmaceutical Manufacturers
Some pharmaceutical manufacturers produce dental and surgical equipment for medical facilities in the UAE. They also need to register their manufactured medical devices with the relevant authorities in the UAE before they can be sold to the clients. These manufacturers must adhere to strict quality control measures and regulatory requirements set by MOHAP to prove the safety and efficacy of their products.
Marketing Offices
Marketing offices serve as intermediaries between manufacturers and healthcare professionals, facilitating the promotion and distribution of dental and surgical equipment in the UAE market. These offices must obtain the necessary approvals and do the required product registration with regulatory authorities such as MOHAP before promoting or selling medical products.
Surgical or Dental Equipment Company Registration with the Ministry of Health and Prevention (MOHAP)
When your surgical or dental equipment has been registered and classified by the Ministry of Health and Prevention (MOHAP), you have two options, direct sales or use intermediary sellers. Choosing the appropriate option depends on your business model and objectives. Regardless of what option you opt for, making sure compliance of the medical devices with MOHAP guidelines is essential for smooth operations within the healthcare sector in the UAE. Here are your options to consider:
Utilization of Intermediary Registered Sellers
If your company prefers to use an intermediary registered seller to distribute to healthcare systems or hospitals, no registration or warehouse is required. This option allows for effortless distribution without the need for direct involvement in the storage and sale process.
Direct Sales to Hospitals or Health Facilities
Alternatively, if your company intends to import surgical or dental equipment and sell directly to hospitals or any health facility, you must register as an authorized reseller of the equipment with MOHAP. This process involves meeting specific guidelines set by MOHAP, including:
- Ensuring that the medical institution purchasing the equipment has qualified staff capable of operating it. For instance, an X-ray machine would require a qualified radiologist to purchase and operate the device.
- Establishing a warehouse facility with a minimum size of 2,000 square feet, complying with fire safety regulations, and equipped with air conditioning to safeguard the imported equipment from heat damage during storage.
Steps Involved in the Import of Dental/Surgical Equipment in the UAE
Here are the steps that you need to take in order to import dental/surgical Equipment in the UAE:
Forming an LLC Company with DED
Begin by registering a Limited Liability Company (LLC) with the Department of Economic Development (DED). Make sure to select the appropriate activity list related to the nature of your surgical or dental equipment business during registration. Additionally, register your company with the UAE Customs Department to obtain the necessary import/export code for shipping medical devices into the Emirates.
Registering the Dental/Surgical Equipment with the Ministry of Health
Next, you need to register your company’s dental/surgical product with the Ministry of Health. Obtain approval from the concerned Health Authorities for the specific business activities and medical products intended for sale in the UAE. Also, make sure all legal clearances and documentation are acquired before commencing trade to stay safe from legal repercussions and penalties.
Working with a Local Distribution Agent
Alternatively, you can opt to engage a local distribution agent or commercial agent for selling equipment in the UAE. These agents are registered with the Ministry of Health and authorized to carry out imports and distribution of dental/surgical products in the UAE. The appointed agent will then proceed to register the medical devices with the Ministry of Health on behalf of your company. Additionally, the commercial agency or local agent will hold the distribution rights of the product in the UAE.
Register Dental or Surgical Equipment in the UAE with RIZ & MONA CONSULTANCY
Starting a medical device trading or importing & re-exporting or reselling business in the UAE is a fine idea. But before taking this step, it is important for you to go for surgical or dental equipment registration in the UAE.
However, dealing with the complexities of medical device registration in the UAE can be daunting. That’s where RIZ & MONA CONSULTANCY steps in. With our expertise, we make the process easy, guiding you from business formation to medical device registration.
Explore the vast opportunities in this thriving economic hub with our knowledgeable insights. Don’t miss out on the benefits awaiting you. Reach out to us today to kickstart your medical, pharmaceutical, or healthcare business venture in the UAE. Don’t waste any time and schedule your free consultation now.
FAQs – Frequently Asked Questions
How much does it cost to register a medical device in UAE?
The cost to register a medical device in the UAE depends on what device you want to register. Depending on your device, the cost of the product registration can vary. It can also vary due to certain other factors such as location, target audience, etc.
How to start a dental/surgical equipment business in UAE?
Here is how to start a dental/surgical equipment business in Dubai:
- Select a legal business structure
- Choose a business jurisdiction
- Reserve your trade or business name
- Select your business activities
- Get the necessary licenses, approvals, and permits
What is the classification of medical equipment in the UAE?
The classification of the medical equipment in the UAE is as follows:
Risk Criteria (Medical Device Class)
- Low Risk (I)
- Low Moderate Risk (IIa)
- Moderate-High Risk (IIb)
- High Risk (III)
Who regulates medical devices in the UAE?
MOHAP or the Ministry of Health and Prevention is responsible for regulating medical devices in the UAE. You need to register your medical devices including surgical or medical equipment with this regulatory authority before you can sell them in the UAE.
