How do I import and sell Medical Devices in the UAE?
How do I import and sell Medical Devices in UAE?
In order to import Medical Devices, Medical Equipment and the corresponding consumables into Dubai, Abu Dhabi and the wider UAE there are a number of requirements:
The distribution and importation of Medical Devices in the UAE is controlled by the Ministry of Health (Ministry of Health and Prevention) which is a Federal body and regulates the importation and distribution of Medical Equipment and Consumables in all Emirates.
In order to import and sell Medical Devices and Equipment into the UAE, firstly the company importing the equipment must be correctly set up and registered with the Ministry of Health with the correct activities on the Department of Economic Development (DED) Trade Licence. The importer must be a legal entity established in the UAE or an UAE national.
Then the Medical Equipment itself needs to be individually registered with the UAE Ministry of Health.
Companies wishing to import and distribute medical products within the UAE (sell medical equipment) must therefore establish their own legal entity, such as a medical supply business, in the UAE and apply for registration of that company with the Ministry of Health.
Alternatively the company can look to engage a local distribution agent or commercial agent who is already registered with the Ministry of Health for the importation and distribution of medical products. That agent will then register the medical products for them - be aware that in the case of commercial agency the local agent appointed will then become the agent for those products and will effectively own the distribution rights to them in UAE. It can be very difficult to unwind a commercial agency agreement in the future if the agent is not performing.
The two key activities listed in the Dubai DED relating to Trading and Importing of Medical Equipment, Instruments and Devices are as follows:
1. Medical, Surgical Articles & Requisites Trading
Includes reselling of certain instruments and precise medical apparatuses for treating of certain diseases, such as earphones, batteries for cardiac patients, pulse regulators, walking-sticks, splints for bone fractures, medical shoes, artificial limbs, dentures and other medical instruments, also, surgical requisites like artificial organs and parts to replace damaged organs, bone joints, heart valves, in additional to surgical suture bandages and plasters.
2. Medical, Surgical Equipment & Instruments Trading
Includes selling medical devices, reselling instruments and equipment used in hospitals and clinics for diagnosis, treatment, surgical operations, medicine and blood preservation, X-raying, sterilization, waste disposal, physical therapy and rehabilitation, also, manual kits and instruments used for check-up, surgical operations and bandaging, as well as electronic devices using communication techniques.
These two Medical Devices trading activities can be issued on the same licence so this can cover a wide scope. They can be done through setting up an Limited Liability Company (LLC), which can be 100% foreign owned. Some businesses opt to have a Corporate Nominee Partner like PRO Partner Group, holding 51% or less, providing majority Foreign Party ownership. The choice to have a Corporate Nominee Local Partner can in some cases remain in the businesses best interest in easing the process of conducting business with local or government medical facilities and/or persons.
Establishing your own company in the UAE or using a Corporate Nominee Partner means you would not require a commercial agent to import these types of goods and the foreign party can maintain control and be safeguarded long-term. Some of the benefits of using a corporate partner can be found below:
There are no external approvals required from the DED to obtain the trade licence, however once the Trade Licence has been obtained the company importing the goods will need to make sure the following steps are completed for each product.
Product registration with Ministry of Health and Prevention (MOHAP)
1. Classification by Ministry of Health and Prevention. The MOHAP will issue a certificate of classification if this product meets use rules and regulation to import and sell in UAE. Each product costs AED 500 to registered. This is to check the product is safe and also that this product is not already registered. It can take 10 working days for registration of the product.
2. Registration of the product to enable the product to be sold within the UAE. Cost is AED 5,100 per product for application and registration. This can take up to 45 working days.
Company registration with Ministry of Health and Prevention (MOHAP)
Once the product has been registered and classified the importer has a choice of 2 options set out below:
1. If the company wishes to import the good and sell directly to the hospitals or any health facility, then the company (importer) will need to be registered as an authorised reseller of the devices. In this basis the importer will need to register with MOHAP and to meet their guidelines which include taking a minimum warehouse space.
a. The warehouse facility should be a minimum of 2,000 sqft, meet Fire Safety requirements and also have air conditioning to protect imported medical devices against the heat of storage.
b. When the authorised importer is selling to the medical institution, the said institution is required to have qualified staff to operate 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 company wishes to use an intermediary registered seller to the healthcare systems/hospitals. In this case no registration or warehouse is required.
PRO Partner Group can provide services to assist you with importation and registration of medical products and devices. We can also assist with Department of Health (DOH) approvals and guidance throughout the necessary company setup and company and product registration procedure. In addition PRO Partner Group can also act as the secure corporate local partner if required ensuring that the foreign party has full control on the company and products, branding and IP. For further information or assistance, please get in touch with us below.