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Medical or Healthcare business is booming all over the world. The people in the UAE lead a hectic work and social life. Medical Equipment Trading Business in Dubai The healthcare facility of the country has improved significantly in the past few years with the aim to provide top class diagnostic and treatment facilities to the citizens.
As per a survey conducted by WHO, one in three adults in UAE are obese, and one in five is diabetes. Thus, there is a need to provide high-quality health care facilities to the citizens of the country.
The UAE government is doing all that it can to woo medical tourists to the country by providing excellent healthcare facilities. The UAE has a lot of advantages that help in the development of the healthcare facility.
The country has an excellent infrastructure and well-built transportation and logistics facility that helps to connect people from different parts of the world. In addition to this, the country has adopted an innovation-driven approach to boosting the healthcare industry. All this provides an excellent opportunity for the medical business set up in Dubai.
Activity has to be registered as either Mainland or Free Zone structure, however, both structures require certain approvals from the following authorities:
A. Dubai Municipality.
B. Ministry of health.
C. Department of Environment.
Considering the current situation of COVID-19, the global pandemic, the importation, and buying of the medical device have become a mainstream requirement for healthcare clinics and hospitals significantly. It has become a need of the hour to meet
As per a survey conducted by WHO, one in three adults in UAE are obese, and one in five is diabetes. Thus, there is a need to provide high-quality health care facilities to the citizens of the country. the rising demand for numerous equipment such as testing kits, PPE suits, ventilators, and more medical devices.
All the medical devices must be approved by the UAE Ministry of Health (MOH) Drug Registration and Control Department
Filled application form, signed and stamped by an authorized person in the company
Issuing notarized and authorized original letter to a local establishment, giving an authority to submit the registration files on their behalf to the Drug Department & Distribution Rights
Valid ISO 13485 certificate issued by the corresponding authority in the country of origin for each site involved in the manufacturing process of medical devices (notarized and legalized)
Detailed company profile
Products list manufactured or assembled by the site
Legal and valid manufacturing license issued by the competent authority in the country of origin
Once the procedure is completed UAE, Ministry of Health provides a registration number with the 5-year validity
Application form from the Department of Economic Development (DED) to register the business
Notarized and authorized letter to be submitted to the Ministry of Health for getting the required clearance for the imports of medical devices.
ISO 13485 certification issued for the manufacturing unit of medical devices in the country of origin.
Company profile in detail
List of products manufactured and imported to the UAE
Manufacturing license of the company in the country of origin.
Documents Required to Complete the Registration Process
The license of the medical warehouse issued by MOHAP
The license of the pharmacist in charge of the warehouse
Valid trade license of the warehouse
Product Minor Variation Certificate, if any
Information, catalog, and pictures of each product as per the invoice
Product Registration Certificate, if any
Certificate of free sale issued by the country of Uae
Good Manufacturing Certificate (GMP)
Purchase invoice and include the country of origin and dates of production and expiry
Product Quality Certificate (C.E. – ISO – FDA Certificate)
1. Classification by the Ministry of Health and Prevention. The MOHAP will issue a certificate of classification of medical products if this product meets the use of rules and regulations to import and sell in the UAE. Each product costs AED 500 to register.
This is to check the product is safe and also that this product is not already registered. As per a survey conducted by WHO, one in three adults in UAE are obese, and one in five is diabetes. Thus, there is a need to provide high-quality health care facilities to the citizens of the country. It can take 10 working days for registration of the product.
2. Registration of the merchandise to enable the merchandise to be sold within the UAE. Medical Equipment Trading Business in Dubai Registration Cost is AED 5,100 per product for application and registration. This can take up to 45 working days.
Once the merchandise has been registered and classified the importer features a choice of two options began below:
1. If the corporate wishes to import the great and sell on to the hospitals or any clinic, then the corporate (importer) will get to be registered as an authorized reseller of the devices. On this basis the importer will get to register with MOHAP and to satisfy their guidelines which include taking a minimum warehouse space.
a. The warehouse facility should be a minimum of two,000 sqft, meet Fire Safety requirements, and even have an air-con to guard imported medical devices against the warmth of storage.
b. When the authorized importer is selling to the clinic, the said institution is required to possess qualified staff to work the devices. As an example, an X-ray machine would require a qualified radiologist to be allowed to purchase/operate the device.
2. If the corporation wishes to use an intermediary registered seller to the healthcare systems/hospitals. In this case, no registration or warehouse is required for a medical trading Medical Equipment Trading Business in Dubai
Foreign investors who want to open companies within the healthcare sector in Dubai must concentrate on the qualifications of the personnel providing medical services. The following licenses are often obtained by those practicing a medical community in Dubai:– a general practice license
a physician license;
a dentist license;
a nurse license;
an allied healthcare professional license;
clinical operating permit.
As the product is registered with the authority and classified, the importer has two options to initiate the trade.
Option -1 Direct Selling
Take a minimum warehouse space and register as an authorized reseller of the devices from the Dubai Economy (form an LLC Company in the Mainland of UAE).
Warehouses with International Standard for storing Medical Devices Safely
The warehouse has got to be equipped to store the medical devices safely and has got to meet international standards. It will enable you to directly sell to hospitals or any health facility.
The health facility or hospital has to have a qualified employee to operate the medical devices.
Option -2 Using an Intermediate Registered Agent
If a company is using a third-party registered agent there is no requirement of any warehouse space. The registered agent will act as the authorized reseller and distribute the medical devices on behalf of your company.
No imported medical Product will clear the customs unless the pre-approval is issued by the UAE Ministry of Health. One needs to get a medical warehouse license from the Ministry of Health.
The UAE Ministry of Health will inspect the warehouse prior to issuing the license of medical. Once the location and warehouse have been inspected, the company must provide the relevant documents to the authority. The required documents are:
Proof of the inspection
Information relating to the medical and pharmaceutical devices that the company intends to import
Once the documents have been reviewed, the authority has the right to accept or reject the proposal
If the Ministry accepts the file, it is passed to a final committee at the Ministry of Health
The final committee meets four times a year to review all the proposals, and the best one is given the import license
If the application is rejected, the authority will provide the reason as to why. This permits the company to make the necessary adjustments and apply again for the same.
Step 1: Opening an LLC Company in Dubai Mainland
To start your operations of import and distribution of medical devices in Dubai, you must register as an LLC Company with the DED. For this registration, you must select the appropriate business activity related to the nature of the business. Then, register with the customs to get the import/export code for shipping in the medical devices into the country.
Step 2: Register the Medical Products with the Ministry of Health
The company’s medical products must be registered with the Ministry of Health in Dubai. Medical Equipment Trading Business in Dubai Concerned Health Authorities must approve the right business activities, medical products before selling them in the UAE. Obtain all legal documentation and clearances before conducting trade in the UAE to avoid penalties and legal actions.
Step 3: Working with a Local Distribution Agent
On the other hand, the company can engage a local distribution agent or commercial agent. The local distributor/agents are registered with the Ministry of Health for carrying out imports and distribution of medical products in Dubai, UAE.
Medical Equipment Trading Business in Dubai On behalf of the company, the agent will then register the medical products with the Ministry of health. The commercial agency/local agent will own the distribution rights of the product in the UAE.
We at BCM Corporate services LLC, extend our quality services to our client with well experienced & qualified Business consultants with rich expertise in Medical Equipment Trading Business in Dubai . so that client’s requirements of Business setup in Dubai. can be completed on time with satisfactory Results outcome. Please feel free to reach us for your Business setup and Start Medical Equipment Trading Business in Dubai requirements on our email id: info@branches.ae or call us on +971502585921 WhatsApp +971-551196792