Opening an Operating Suite: Requirements for Premises, Equipment, and Staff

Opening your own operating room is an ambitious step that can take a medical center to a new level. It creates an opportunity to perform complex procedures, significantly expand the range of services, and provide comprehensive patient care. However, between the idea of creating a modern surgical facility and performing the first legally authorized procedure lies a complex framework of Ukrainian state construction standards, sanitary regulations, and Ministry of Health requirements.

Many clinic owners and patients see an operating room as simply a room with good lighting and a sterile surgical table. For regulators, however, an operating suite is a complex and carefully coordinated safety system. Every square meter, every ventilation component, and every anesthesiologist's qualification must comply with strict regulatory requirements.

The most frustrating mistake is completing an expensive renovation, purchasing high-end equipment, and only then discovering that the facility does not meet the requirements for obtaining a medical practice license.

This article explains how to establish an operating room on a turnkey basis so that it is not only modern and functional but also fully compliant with licensing requirements.

When Does a Clinic Really Need Its Own Operating Room?

Private clinics usually begin with outpatient services such as consultations, ultrasound examinations, and simple procedures performed under local anesthesia. However, a successful business can quickly reach what is sometimes called a “glass ceiling” in its development. Loyal patients may be ready to undergo more complex procedures with your specialists, but you may have to refer them to competitors or public hospitals, losing both revenue and patient trust.

So, when does investing in an operating suite become justified?

Transition to Same Day Surgery

If your doctors are prepared to perform minimally invasive procedures in gynecology, urology, or general surgery, having a minor or major operating room can become a necessity. This allows patients to receive qualified medical care and return home on the same day, which is a recognized standard of modern healthcare and an indicator of a high level of clinical practice

Anesthesia and Sedation: A New Level of Responsibility

A critical legal threshold arises when a clinic plans to use intravenous sedation or general anesthesia. Once this threshold is crossed, the clinic becomes subject to stricter requirements regarding the availability of an operating suite, an intensive care or resuscitation unit, and appropriately qualified anesthesiology staff. Without the appropriate medical practice license covering surgery and anesthesiology, such activities are unlawful.

Scaling in Aesthetic Medicine and Dentistry

Scaling a modern aesthetic medicine or dental practice is often difficult without an operating room. Complex dental implant procedures performed under deep sedation or plastic surgery also require a level of sterility and patient safety that can only be provided by a properly equipped operating room.

An in-house operating room can become a major marketing advantage. Patients tend to place greater trust in medical clinics that can provide comprehensive care, from initial diagnosis through surgery and postoperative follow-up.

Please note! An operating room is not only an opportunity to increase revenue but also a significant increase in legal and professional responsibility. From a regulatory perspective, once a clinic declares a surgical specialty as part of its licensed medical practice, greater attention is likely to be paid to its safety standards and compliance with applicable requirements.

You might also like: Can a Sole Proprietor Obtain a License for Surgical Operations in Ukraine?

Designing a Surgical Facility in Compliance with Ministry of Health and State Construction Standards

The design of a medical facility must be guided by safety requirements rather than aesthetics. The structure and number of rooms depend directly on the declared medical specialty, the scope of services, and the planned volume of procedures. There is little room for improvisation here because the requirements are set out in the State Construction Standards and the Ministry of Health licensing requirements.

Every operating suite begins not with the operating table but with a consultation room. This is the foundation of the facility, where patients receive their initial consultation and examination and where the decision to perform a procedure is made. Without this room, the clinic's functional structure may be considered incomplete.

The basic requirements for planning a surgical facility are presented in the table below:

Room sizes are not arbitrary figures. They are part of the safety calculations designed to ensure sufficient space for both patients and medical staff. For example, a single patient room requires a certain amount of space, while a two-patient room must be proportionally larger. As a general rule, the area should be at least 7 to 9 m² per bed for a standard room and at least 13 m² per bed for an intensive care room. This ensures that medical staff and equipment can move freely and have adequate access to each patient.

Advice from our lawyers: Do not try to guess which rooms the Ministry of Health will require for your particular medical profile. We have extensive experience in medical practice licensing and know how to adapt your plans to meet the regulator's strict requirements.

Engineering and Finishing Requirements for a Surgical Facility

Surfaces in an operating room must withstand daily intensive disinfection, ultraviolet exposure, and the operation of powerful medical equipment. Ceilings and walls should be completely smooth, without cracks, gaps, or joints. For this purpose, we recommend using specialized wall panels or certified water-resistant paint that can withstand disinfectants.

The floor should have an antistatic surface covering that extends up the walls, creating a seamless, rounded coved base. This eliminates hard-to-clean areas where dirt and contaminants can accumulate.

Even the lighting requires proper engineering calculations. Installing a heavy shadowless surgical light requires prior reinforcement of the ceiling's load-bearing structure to ensure that the equipment can be securely mounted.

Accessibility: No Barriers, No License

Accessibility is another critical requirement in 2026. A medical practice license cannot be obtained without official expert confirmation that the premises are accessible to people with reduced mobility. This means that the clinic must provide ramps or lifting platforms at the entrance, wide doorways without high thresholds, and a specially equipped restroom with sufficient space for a wheelchair to turn and move freely.

For modern healthcare, accessibility is not merely a legal requirement. It is a fundamental expression of respect, equality, and responsible business practices that directly contributes to the reputation of a medical facility.

You might also like: Precursor License Without Fines or Revocation: Practical Rules for Business

Mandatory Equipment for Surgical Licensing

Regardless of the medical specialty you choose, whether plastic surgery or otolaryngology, there is a basic equipment list that must be in place for an operating suite to pass the required regulatory inspection.

1. Operating room equipment. The operating table should be multifunctional, with adjustable height and positioning angles, and its surface must withstand repeated disinfection. A shadowless surgical light should provide high-intensity illumination without shadows cast by the surgeon's hands during procedures. An important safety requirement is connecting the surgical light to a backup uninterruptible power supply in case of a power outage.

2. Anesthesia equipment. If you plan to perform procedures under general anesthesia, the operating room becomes a higher-risk area requiring additional equipment. You will need:

• an anesthesia machine with a ventilator and monitoring of the respiratory gas mixture;
• a multifunctional patient monitor for real-time monitoring of blood pressure, pulse, oxygen saturation, and ECG;
• a defibrillator that is charged and ready for immediate use;
• syringe pumps for precise administration of medications.

3. Sterilization area. To ensure a complete instrument safety cycle, you will need a Class B steam autoclave capable of reliably sterilizing complex instruments with internal channels, as well as an ultrasonic cleaner or washer-disinfector and dedicated cabinets for storing sterile instruments.

Please note: If you plan to establish a fully equipped operating suite, we recommend approving the list of medical specialties first. For example, the equipment required for plastic surgery can differ substantially from that required for ophthalmic surgery. Our lawyers can help you compare your equipment inventory with the current Ministry of Health equipment requirements so that you do not purchase unnecessary equipment while also avoiding a licensing refusal because of one missing item.

You might also like: Medical Facility Reorganization and Medical License: Apply for a New One or Update the Existing License

Staffing Requirements and Documentation for Medical Personnel

A clinic's professional reputation is built on its people, while its legal security depends on the accuracy and validity of their documentation. The staffing requirements depend on the medical specialties you plan to provide. However, for a fully operational surgical department, three key specialists are generally required:

1. A physician in the relevant surgical specialty (a general surgeon, gynecologist, urologist, plastic surgeon, etc.) with a valid specialist certificate and a qualification category certificate, where applicable.
2. An anesthesiologist, whose involvement is required when providing sedation or general anesthesia. The anesthesiologist is responsible for patient safety throughout the anesthesia process, from the preoperative assessment through recovery from anesthesia.
3. An operating room nurse. While this staff member is not always a mandatory member of the surgical team, in practice, this specialist is the surgeon's right hand. The nurse must have a medical education diploma and specialized training as an operating room nurse.

What the Ministry of Health Checks in Physicians' Documents

When reviewing a medical practice licensing application, the Ministry of Health assesses each healthcare professional according to specific requirements. What personnel documents does the Ministry of Health check?

Educational Background

• Medical degree: The basic document confirming the physician's medical qualification.
• Specialist physician certificate: The document that confirms the physician's right to practice in a specific medical specialty, such as Surgery or Anesthesiology.

Five-Year Cycle and Categories

Medicine is constantly evolving, so physicians are required to continuously update their knowledge and demonstrate professional competence. The Ministry of Health therefore checks:

• Professional development: Traditionally, physicians have been required to undergo professional certification every five years, resulting in a certificate confirming the assignment or confirmation of a professional qualification category.
• CPD (Continuing Professional Development). In 2026, this is no longer merely a recommendation but a mandatory requirement for physicians. A specialist must earn at least 50 CPD points annually through participation in conferences, webinars, workshops, and other professional development activities. When preparing a license application, we check whether the physician's professional development activities have been recorded in their educational portfolio.

The “Career Gap” Trap

This is one of the most critical issues when assembling a medical team. If a physician has not officially practiced their specialty for more than three years for any reason, including parental leave, a career change, or living abroad, their specialist certificate may no longer be valid for licensing purposes.

Such a specialist must officially complete the required internship or refresher training and have their qualification confirmed again. Submitting information about a physician whose professional qualification is no longer valid to the Ministry of Health can result in the refusal of a surgical license and delay the opening of your clinic indefinitely.

Five Main Mistakes When Launching an Operating Suite

Based on our experience with dozens of medical centers, we have identified the most common mistakes that can cost clinic owners substantial amounts of money, sometimes millions of hryvnias, as well as months of lost time. Most importantly, these mistakes can undermine confidence in the project from the very beginning. The most serious errors include:

1. Renovating without a professional medical technology project. Entrusting the planning to a talented designer who has “already designed several clinics” can result in major problems after the work is complete. For example, the premises may not allow for the installation of a proper supply and exhaust ventilation system, or the operating room may be two square meters smaller than required by the State Construction Standards. At this stage, correcting the mistakes can cost several times more.
2. Purchasing equipment without checking its documentation. Even if you find an excellent operating table or laser device at an attractive price, the equipment may be unusable for licensing purposes if the seller cannot provide the required official Declaration of Conformity with Ukrainian technical regulations. Medical equipment must not only function properly but also be legally authorized for use in Ukraine.
3. Ignoring the “career gap” rule for physicians. Hiring a well-known surgeon who has spent the last four years working exclusively in administration or abroad without properly documented professional practice can result in licensing problems if the physician's specialist qualification was not renewed after a three-year interruption.
4. Allowing medical and patient flows to cross. If a postoperative patient's route from the operating room to the intensive care unit passes through a common corridor used by visitors wearing outdoor footwear, the Ministry of Health may reject the proposed layout because of the increased risk of infection and failure to meet basic patient safety requirements.
5. Taking accessibility requirements formally. The assumption that installing a call button at the entrance is sufficient to ensure accessibility is incorrect. Current accessibility requirements are comprehensive and may cover the ramp slope, doorway width, threshold height, wheelchair turning radius, etc.

Legal Support for Opening an Operating Suite and Licensing Medical Centers

Opening an operating suite is a complex engineering and legal project. Our company is ready to become your reliable partner, guiding you through every stage and helping you avoid the common obstacles on the way to obtaining a license.

How can we help, and why is this beneficial for you?

1. Preliminary legal audit. Before you sign a lease or start removing walls, we will analyze the premises and advise whether they comply with the State Construction Standards applicable to your medical specialty.
2. Development of an individual facility structure. Our healthcare law specialists will determine the optimal list of consultation rooms, operating rooms, and auxiliary facilities, including preoperative areas, sterilization rooms, and medication storage rooms, based on your specific needs.
3. Support in obtaining an accessibility assessment. We understand the detailed accessibility requirements and will help prepare the premises so that the expert assessment can be successfully completed on the first attempt.
4. Review of the material and technical base and personnel. We will conduct a thorough audit of your equipment and verify the documentation of each healthcare professional.
5. Preparation and submission of the required information to the Ministry of Health. This is one of the most important stages of the licensing process. We professionally prepare the required information on the condition of the material and technical base, avoiding errors in terminology, equipment names, and job titles that can result in a refusal.
6. Obtaining a license for the handling of narcotic drugs, psychotropic substances, and precursors. We take full responsibility for this critical stage. Our lawyers will support the licensing procedure with the State Service of Ukraine on Medicines and Drugs Control, allowing your anesthesiology service to legally use modern anesthetic medicines and controlled substances.

We do not simply prepare documents. We have practical experience in obtaining licenses for complex surgical specialties and understand what licensing authorities expect to see today and how to adapt your business processes to these requirements.

Contact our company today, and our healthcare law specialists will take care of the entire administrative and legal process.

Learn more about medical practice licensing here.

Learn more about obtaining a license for handling narcotic drugs here.