Diagnostic X-Ray and Radiation Facility Licensing in Bangladesh
Practical legal support in Dhaka with radiation facility licensing in Bangladesh for hospitals, diagnostic centres, dental clinics, veterinary practices, industrial users and equipment suppliers, covering BAERA licences, equipment import clearance, renewals, changes of ownership or premises, inspections and enforcement.
- Map the approvals
- Prepare the file
- Engage with BAERA
- Maintain and protect
Radiation facility licensing in Bangladesh: the regulatory picture
Any facility in Bangladesh that installs and operates radiation-generating equipment, from a single dental X-ray unit to a multi-room imaging department with CT, mammography and fluoroscopy, needs authorisation from the Bangladesh Atomic Energy Regulatory Authority (BAERA). Radiation facility licensing is separate from the clinic or hospital licence issued by the health authorities, and both must be in place before patients are scanned. We advise providers, investors and suppliers on the legal side of that process as part of our regulatory practice in Bangladesh, working with physicists and engineers on the technical file.
BAERA was established under the Bangladesh Atomic Energy Regulatory Act 2012 as an independent regulator for nuclear safety, security and radiation protection. The Act and the rules on nuclear safety and radiation control made under the earlier legislation, as continued and supplemented, require licences or other authorisations for the import, possession, use, transfer and disposal of radiation sources and radiation-generating equipment. Licences are typically granted for a fixed period, subject to conditions, and are not transferable. The regulator issues guidance and forms that change over time, so applications must follow the current versions.
In practice, the process usually covers the facility layout and shielding design, the specification and source of each unit, the qualifications of operators and the radiation control officer, personal dosimetry arrangements, quality assurance and acceptance testing, and emergency procedures. Inspections may take place before and after commissioning. Problems commonly arise when a facility is built or equipment is ordered before the design has been checked against regulatory requirements, leaving the owner to modify walls or change rooms at significant cost after the fact. Early radiation facility licensing review of drawings and specifications avoids this.
Imports add another layer. Radiation-generating equipment generally needs regulatory clearance before Customs will release it, and suppliers, importers and end users must agree who is responsible for each permit. Second-hand and refurbished equipment raises further questions about documentation and safety history. Healthcare investors acquiring hospitals or diagnostic chains need to check that every licence is current and held by the right entity, because a change of ownership, premises or equipment can require a fresh application or notification under the radiation facility licensing framework. Careful radiation facility licensing due diligence protects buyers.
We focus on the legal and documentary aspects: licensing strategy, structure, contracts, regulatory correspondence, and enforcement. Barrister Remura Meheruba Mahbub and our healthcare regulatory team coordinate with medical physicists, equipment suppliers and hospital management. Where BAERA issues a notice, suspends a licence or seals equipment, our litigation team led by Adv Syed Wahid advises on the response and any challenge.
For related clinic and hospital approvals, see our healthcare practice, or contact our Dhaka office to discuss a project. We work in Bangla and English with all stakeholders. Radiation facility licensing is often one part of a wider healthcare project.
Core workstreams
Four clear stages
- 01Map the approvals
- 02Prepare the file
- 03Engage with BAERA
- 04Maintain and protect
Talk to a partner
Consultations in Dhaka or by video. Scope, team and fees are agreed in writing first.
Book →How we support imaging providers and suppliers
Licensing strategy for new facilities
- Map the approvals
- Prepare the file
- Engage with BAERA
- Maintain and protect
BAERA applications and documentation
- Map the approvals
- Prepare the file
- Engage with BAERA
- Maintain and protect
Equipment import and supply contracts
- Map the approvals
- Prepare the file
- Engage with BAERA
- Maintain and protect
Renewals, changes and transactions
- Map the approvals
- Prepare the file
- Engage with BAERA
- Maintain and protect
Inspections and compliance reviews
- Map the approvals
- Prepare the file
- Engage with BAERA
- Maintain and protect
Enforcement and disputes
- Map the approvals
- Prepare the file
- Engage with BAERA
- Maintain and protect
Licensing strategy for new facilities
Before construction or procurement, we map the authorisations needed for the facility: BAERA licences, health licences, trade licence, fire and environmental clearances. We identify the entity that should hold each licence, the sequence of applications and the points where design or equipment decisions affect approval. This prevents the common situation where equipment arrives before the room or the paperwork is ready. Radiation facility licensing comes first.
BAERA applications and documentation
We prepare and review applications for licences covering diagnostic X-ray, CT, dental, mammography, fluoroscopy and similar equipment, with supporting documents on layout, shielding, personnel, dosimetry, quality assurance and emergency planning. We check that technical reports from physicists and suppliers are consistent with each other and with the application, and manage correspondence and follow-up questions from the regulator. Radiation facility licensing files are kept consistent. Inconsistent details, such as room dimensions or equipment models, can prompt regulator queries and delay a decision.
Equipment import and supply contracts
We advise importers, distributors and buyers on regulatory clearance for radiation-generating equipment, customs release and the allocation of permit responsibilities in supply contracts. Contracts should cover installation, acceptance testing, documentation, warranty, servicing by qualified engineers, and the return or disposal of equipment at end of life, including refurbished units, which attract additional scrutiny from regulators and Customs. Each party's duties for permits, installation and acceptance testing should be written down, with final payment tied to delivery of the documents.
Renewals, changes and transactions
Licences must be renewed on time and amended when equipment, premises, ownership or key personnel change. We maintain renewal schedules and advise on notifications. In hospital and diagnostic-centre acquisitions, we conduct radiation facility licensing due diligence and plan how licences will be maintained, transferred by fresh application, or reissued after completion, so that services are not interrupted. We confirm in each case whether a change needs prior approval or only notice to the regulator.
Inspections and compliance reviews
We help facilities prepare for regulatory inspections by reviewing licences, conditions, dosimetry records, quality assurance reports and staff training records against the current requirements. Where gaps appear, we advise on corrective steps and on how to communicate them to the regulator. A documented internal review is valuable evidence if questions are later raised by BAERA, patients or insurers. Operators and the radiation control officer should also be briefed on what inspectors may ask.
Enforcement and disputes
Where a facility receives a show-cause notice, a direction to stop using equipment, a suspension or a penalty, we prepare the response, propose corrective action and represent the client in meetings and hearings. If a decision is unlawful or disproportionate, we advise on appeal and writ proceedings. We also handle contractual disputes with equipment suppliers over defective units or missing documentation.
Partner-led, on every matter.
Trade, Competition & Regulation matters at TRW are led by partners, supported by associates, with one responsible lawyer from first advice to final outcome.
Meet the firm →01Does a small dental clinic with one X-ray unit need a BAERA licence?
Generally yes. Radiation-generating equipment, including intraoral and panoramic dental X-ray units, falls within the regulatory framework regardless of the size of the practice. The requirements may be simpler than for a hospital imaging department, but the clinic still needs proper authorisation, a responsible person, shielding appropriate to the room, dosimetry for staff where required and quality assurance. Operating without a licence exposes the practice to enforcement and can cause problems with health licensing and insurance. We help small practices understand the radiation facility licensing steps and prepare a proportionate, complete application. Small clinics often underestimate this.
02What is the difference between a BAERA licence and a DGHS clinic licence?
They cover different risks. The Directorate General of Health Services and the health ministry regulate private clinics, hospitals and diagnostic laboratories as healthcare establishments, under the private clinic and laboratory licensing regime. BAERA regulates radiation safety: equipment, shielding, personnel and protection of patients, staff and the public. A diagnostic centre normally needs both, and the conditions of each can affect the other. We coordinate the two processes so that the facility can open on time and the radiation facility licensing file is consistent with the health licence application. We can map both together.
03Can we order X-ray or CT equipment before the facility licence is granted?
Commercially, many providers place orders early because lead times are long. Legally, the import, possession and installation of radiation-generating equipment may each require clearance, and Customs may not release equipment without the required regulatory documents. Ordering is therefore possible, but the purchase contract should allow for regulatory delays, make clear who obtains import clearance, and give the buyer protection if the equipment cannot be cleared or installed. We review procurement contracts so that the commercial timetable reflects the radiation facility licensing timetable rather than ignoring it. Suppliers usually accept reasonable delay terms.
04Is a radiation facility licence transferable if we sell the hospital?
Licences are generally granted to a named licensee for specified equipment and premises, and are not freely transferable. In a share sale, the licensee entity remains the same, but changes in control or responsible personnel may still need notification. In an asset sale, the buyer usually needs its own authorisation before taking over operation of the equipment. We plan the regulatory steps alongside the transaction timetable, include appropriate conditions and warranties in the sale documents, and make sure imaging services can continue lawfully through completion. Planning avoids gaps in service.
05Who should be the radiation control officer for a facility?
Facilities are normally required to designate a suitably qualified and trained person responsible for radiation protection within the facility, often called the radiation control officer. The precise qualification and training requirements depend on the type of facility and the current regulatory guidance. The role carries real responsibility for safety procedures, records and liaison with the regulator, so it should be documented in an appointment letter that sets out duties and authority. We advise on these appointments and on the legal implications if the officer leaves or is unavailable. Written appointments help in inspections.
06Can refurbished or second-hand imaging equipment be imported and licensed?
It may be possible, but it attracts closer scrutiny. Importers should expect to provide documentation on the equipment's origin, service history, condition and compliance with applicable standards, and regulators or Customs may impose additional conditions or refuse clearance. Import policy restrictions on used goods may also apply. Buyers should obtain contractual warranties covering documentation and regulatory acceptance, and clear remedies if clearance is refused. We review the regulatory position and supply terms before commitment, since radiation facility licensing problems with refurbished units are difficult to solve after shipment.
07What happens if BAERA finds a problem during an inspection?
Outcomes range from recommendations and a deadline for corrective action to directions to stop using equipment, suspension of a licence or penalties for serious breaches. The facility should obtain the findings in writing, respond within any time limit, and document corrective steps taken. Where the findings are disputed, the response should explain why with technical support. We help facilities prepare accurate responses, engage with the regulator and, where necessary, challenge disproportionate measures, while making sure that genuine safety issues are fixed promptly and properly recorded. Timely responses protect the licence.
08Do veterinary practices and industrial users need a radiation facility licence?
Radiation-generating equipment used outside human healthcare, such as veterinary X-ray units, baggage scanners, industrial radiography and analytical instruments, generally also requires authorisation, although requirements differ by category. Industrial radiography and sealed radioactive sources raise additional security and transport issues. Each business should check the current categories and conditions with the regulator before acquiring equipment. We advise veterinary, industrial and security clients on the radiation facility licensing route that applies to their activity, and on contracts with suppliers and service engineers. Categories should be checked first. Radiation facility licensing rules differ by category.
From first call to resolution.
- 01
Map the approvals
We review the planned facility, equipment, premises and ownership, identify every authorisation needed, and set out the sequence of radiation facility licensing and health licensing steps. Risks and timing are flagged early.
- 02
Prepare the file
With the client's physicist and supplier, we assemble applications, technical reports, personnel documents and contracts, checking that every document is consistent and up to date. Gaps are fixed before filing.
- 03
Engage with BAERA
We file applications, respond to queries, support inspections and keep a written record of conditions and commitments so that the licence reflects how the facility actually operates.
- 04
Maintain and protect
After licensing we track renewals, changes and inspections, and act promptly on any notice, suspension or dispute that threatens the facility's ability to operate. Radiation facility licensing records stay current.
“Demonstrates an extraordinary command over both domestic litigation and international arbitration.”
The Legal 500 Asia Pacific, Bangladesh: Dispute resolution, client feedback
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All insights →
Which authority handles radiation facility licensing in Bangladesh?
How long does radiation facility licensing take?
Do mobile and portable X-ray units need separate authorisation?
What records must a licensed X-ray or imaging facility keep?
What happens to X-ray equipment and sources at the end of their life?
Does radiation facility licensing apply to teleradiology providers?
Can a foreign investor own a licensed diagnostic centre in Bangladesh?
Can TRW carry out radiation safety assessments or shielding calculations?
Plan your imaging facility licences with confidence
Speak with the partners about Radiation facility licensing in Bangladesh or across borders.
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