Overview of Medical Laboratory Setup:

As medical sector in Dubai is booming, several medical clinics and hospitals are in place in Dubai and as the country develops and improves its infrastructure, more of these clinics and hospitals are sure to come. In this scenario, there is a high demand for laboratories as the clinical industry and the laboratories go hand in hand. The authority which regulates medical laboratory in Dubai is the Dubai Health authority (DHA). With all development and regulations, DHA makes sure that all the practicing clinical laboratories provide the best quality of services.
Clinical Laboratory by definition means a place or an institution where all the procedures of the examination taken from the human body are tested in order to obtain the result through various practices like pathology, microbiology etc. for further diagnosis or treatment.

Authorities Involved in Licensing Process

Clinical Laboratory services in Dubai could be issued as an independent laboratory or as a part of hospitals, Polyclinics or specialty centers. The Licensing authority is DHA to operate a laboratory, in addition to a license which will be issued from the Department of Economic Development for mainland under professional license or in Dubai Healthcare city Free Zone Authority.

Procedure to Issue a Laboratory License

As for any Mainland License, the process for a Medical Laboratory license starts with approaching the Department of Economic Development (DED), Dubai, for the trade name and the Initial approval. Upon receiving the same, an application needs to be filled and processed with the Dubai Health Authority (DHA) for its approval. During the time of initial approval for the facility from DHA, the proposed layout plan of the facility needs to be provided.

Facility Space Requirement

The facility could be a commercial retail space, commercial office or a commercial villa. The size of the facility depends on the number of specifications taken under the facility. every specification like pathology, X-RAY etc requires a separate treatment room. the common reception along with the waiting areas need to be allocated. If the facility is in a retail space or a villa separate male and female toilets to be maintained. In case of an office, this can be omitted if the floor has the same. The approximate requirement of the space would be a minimum of 1000 sq ft. but it again depends on the above requirement.

Upon the approval of the layout of the facility, an NOC is issued from DHA through which the DED authority would issue the trade license. But the laboratory facility becomes operation only upon receiving the final DHA License, which is done by completing the requirements of the fit out as per the approved layout. The layout must clearly depict the whole clinic with proper rooms for examination. The total number of rooms depends on the laboratory services provided by the independent facility. Upon the final inspection of the facility, a Laboratory operational permit is issued from DHA.

Who can own a Laboratory License?

The beauty of this business is that any individual having an interest or an idea to invest in a laboratory can own the license from both DED as well as DHA. But a non DHA Licensed practitioner must appoint a DHA-licensed medical director on the trade license who would take care of the practice in the clinical laboratory. The medical director needs to be sponsored by the company for the residency in order to enter the license.

Requirements for Setting up a Medical Laboratory

• The laboratory needs to be in operation as per the standards of DHA.
• The safety measures need to be taken into consideration as per the regular standards of civil defense and DHA.
• A general quality assurance program is provided in order to have a standardized procedure followed by all the licensed facilities.
• Random inspections from the DHA authority are made to make sure the facility is running as per the set guidelines.
• All the licensed facilities must follow a standard operation procedure which could cover both analytical and operational procedures. This could vary from a facility to facility.
• All the laboratory equipment’s need to be well maintained by periodic inspection and cleaning.

Medical Laboratory Setup Cost

Approx total cost for medical laboratory setup will be AED 18,500 ($5040) with one specialty. This Medical Laboratory Setup Cost in Dubai includes only Government fee up to the issuance of license and cost breakup for DED and DHA.
But with the help of expert advisors, we’ve pinned an approximate number to each of these costs, so you can start to understand, in a real sense, what your startup costs will look like.

Investor Visa eligibility criteria

The license once is issued is eligible to have a maximum of 2 investor visa’s whose name appears on the MOA.

In a nutshell, all the facilities are approved and inspected by the DHA and it is mandatory to understand all the procedures and processes well in advance along with the thought of owning a facility. We at Flyingcolour business setup in Dubai and UAE are specialized in the procedures of setting up a laboratory license with both DED and DHA. For further details and an experienced consultancy services for the same reach us on +9714542366 or email info@flyingcolour.com. This blog post written by Ms. Sowmya, CEO at Flyingcolour Business Setup in Dubai, emphasize in providing the best advisory and customer satisfaction to clients.