FANR License and X-Ray Facility Approvals in the UAE

Who regulates X-ray equipment in the UAE

Several bodies are involved. FANR is the federal regulator for radiation sources, so facilities that use X-ray equipment normally register or obtain authorisation from it, depending on the type of source and activity. The Ministry of Health and Prevention (MOHAP) deals with medical-device registration at federal level, while the Dubai Health Authority (DHA), the Department of Health Abu Dhabi (DOH) and other emirate-level bodies license healthcare facilities and professionals.

Because the split of responsibilities can differ by emirate and by facility type, the first practical step is a written confirmation from each authority of what it requires for your specific equipment. Do not rely on general summaries, including this one, for the final decision.

It also helps to keep one point of contact for regulatory correspondence in your facility, usually the RPO or the facility manager, so that questions from different authorities are answered consistently and nothing is lost between departments.

Typical elements of an X-ray license application

While the exact forms and sequence are set by the authorities, applications for diagnostic X-ray usually draw on the same group of documents. Expect to describe the equipment (manufacturer, model, tube and generator data), the room and its shielding, the people responsible for radiation safety, and your arrangements for dose monitoring and quality assurance.

The following items are commonly requested; confirm the current list and format with FANR and your health authority before preparing the file.

• Equipment details and supplier documents for the X-ray unit
• Room drawings and a shielding assessment by a qualified expert
• Appointment of a radiation protection officer (RPO) and staff training records
• Personal dosimetry arrangements for exposed workers
• Quality assurance and acceptance testing plan
• Emergency, safety and local rules for radiation work

Shielding report, RPO and dosimetry

The shielding report is based on the room layout, the expected workload, the use factors of walls and floors and the occupancy of adjacent areas. It specifies lead or equivalent for walls, doors, windows and, where needed, floors and ceilings. Practical design points are covered in our guide to X-ray room shielding.

The radiation protection officer is the person accountable for local radiation safety, from training and local rules to incident handling. Personal dosimetry for exposed staff is a related requirement; see radiation dosimeter badges for how monitoring typically works.

Acceptance testing and your sequence of steps

A sensible sequence starts before purchase. First agree the room and shielding design with the supplier, then confirm the licensing path with the authorities, install and commission the equipment, perform acceptance tests with a qualified physicist and only then start clinical use once approvals are in place. Our article on X-ray quality control tests explains the acceptance and constancy tests that regulators expect.

Plan the room early with the layout guide in X-ray room design requirements. Ordering the unit before the shielding and permit steps are clear is a common cause of delay.

Keep copies of all acceptance test reports, shielding calculations and the supplier's installation records. They are needed again when equipment is replaced, relocated or when a licence is renewed.

How the supplier can help

A supplier cannot replace the facility's regulatory responsibilities, but it can provide manufacturer documents, technical data sheets, pre-installation requirements and commissioning support. Ask any supplier for the documents it will provide for your file, and when they will be available.

Beckfinity supplies Villa and Perlove X-ray systems and offers installation support. If you are planning a new X-ray room in Dubai, Abu Dhabi, Sharjah or elsewhere in the UAE, contact our team to discuss the equipment documents you will need. Final licensing decisions always remain with the authorities.