Lawyer
An expert in medical law and medical practice licensing. Specializes in supporting clinics, dental practices, beauty centers, and medical offices, obtaining and amending licenses, preparing for inspections, and advocating for their interests in interactions with the Ministry of Health and regulatory authorities.
License for a diagnostic center
Diagnostic centers are one of the most dynamic areas in the development of private medicine. Modern patients increasingly turn to private institutions to undergo ultrasound, functional, or radiation diagnostics, as it allows them to quickly get examination results without a long wait.
At the same time, opening a diagnostic center is not only about purchasing modern equipment. To legally provide medical services, it is necessary to obtain a medical practice license and ensure that the premises, personnel, and material and technical base comply with the requirements of the Ministry of Health. For this purpose, it is advisable to order professional legal services for medical business in advance.
A specific feature of such institutions is that the licensing requirements depend not only on the doctors’ specialties but also on the type of diagnostic examinations planned to be conducted.
What is considered a diagnostic center
By the term “diagnostic center,” we usually mean a medical institution specializing in conducting diagnostic examinations necessary to establish a diagnosis, monitor a health condition, or evaluate the effectiveness of treatment.
Depending on the concept of the institution, a diagnostic center may provide:
- ultrasound diagnostics (US);
- functional diagnostics (ECG, Holter, spirography, EEG, etc.);
- endoscopic examinations;
- X-ray examinations;
- computed tomography (CT);
- magnetic resonance imaging (MRI);
- consultations by doctors who interpret the examination results.
It is the list of planned services that determines the requirements for the premises, equipment, personnel, and licensing documentation.
Where to start opening a diagnostic center
Before investing in expensive equipment, it is necessary to determine the operating model of the future institution. A consultation with a medical lawyer at the initial stage will save you from critical mistakes.
At this stage, it is recommended to:
- determine the list of diagnostic services;
- choose the legal form (Sole Proprietorship / FOP or LLC);
- select the appropriate NACE (KVED) codes (in particular 86.22, 86.90, etc.);
- form the staff of medical workers;
- check the premises for compliance with the Ministry of Health requirements and state building codes (DBN).
What Ministry of Health requirements must be met
Licensing a diagnostic center has its own specifics, attention should be paid to:
- the area and functional purpose of the premises;
- the compliance of the equipment with the declared examinations;
- the qualifications of the doctors and the availability of CPD points;
- the presence of paramedical / nursing personnel;
- ensuring barrier-free access (inclusivity for people with limited mobility);
- the organization of medical waste management;
- the internal organization of the institution’s work.
Important! If the center conducts X-ray examinations, computed tomography, or other activities related to the use of ionizing radiation sources (IRS), it is also necessary to take into account the special legal requirements in the field of radiation safety and obtain additional permits.
| Assessment criterion | Center of ultrasound/functional diagnostics | Center of radiation diagnostics (CT, MRI, X-ray) |
|---|---|---|
| Main services | Ultrasound, ECG, Holter, EEG | CT, MRI, radiography |
| Requirements for premises | Standard offices in compliance with sanitary norms | Specialized premises with radiation protection (for X-ray/CT) |
| Additional permits | Ministry of Health license for medical practice | Ministry of Health license + radiation safety permits (SNRIU) |
| Staffing | Doctors of ultrasound/functional diagnostics | Radiologists, X-ray technicians, radiation safety engineers |
What documents must be submitted to the Ministry of Health
To obtain a medical license, the following are submitted:
|
🏥
Information on the state of the material and technical base, availability of personnel indicating their educational and qualification level;
📋
Inventory of documents (in two copies).
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At the same time, the “Information” document is the main one that reflects the actual operating model of the diagnostic center: specialties, equipment, premises, and staffing. The correct completion of this document most often determines the success of obtaining the license.
Most common mistakes when opening a diagnostic center
In practice, center owners often:
- purchase equipment even before analyzing the premises and its area;
- rent premises that do not comply with building codes;
- do not take into account special requirements for X-ray equipment and protection;
- incorrectly determine the medical specialties;
- do not check personnel documents and compliance with CPD requirements;
- do not organize a medical waste management system.
Legal support for opening a diagnostic center from Prikhodko & Partners
Prikhodko & Partners Law Firm offers comprehensive legal support for medical business and turnkey opening of diagnostic centers at all stages of project implementation.
We help:
- determine the optimal activity model;
- check the premises even before the start of renovation;
- form a list of specialties;
- check the documents of medical workers;
- prepare information on the material and technical base without mistakes;
- form a package of documents for the Ministry of Health;
- support the procedure for obtaining a license;
- advise on further expansion of the medical practice license.
We do not limit ourselves to the preparation of documents — our goal is to create a legally safe operating model for the diagnostic center that will comply with the requirements of the law and allow the owner to focus on developing the medical business.
Opening a diagnostic center requires strict compliance with medical and building codes. To avoid mistakes at the renovation stage and be guaranteed to obtain a Ministry of Health license, entrust legal issues to the professionals of Prikhodko & Partners Law Firm. Leave a request on the website, and we will ensure a safe and legal start to your medical business!
Calculate the cost of services
1 question
Are you planning to open an ultrasound, MRI, or X-ray center?
2 question
Do you need an inspection of the premises for compliance with the Ministry of Health requirements?
3 question
Have you already selected or rented premises for the future clinic?
Do I need a separate license for a diagnostic center?
No. A diagnostic center obtains a license to conduct economic activities in medical practice, but specifying the relevant medical specialties and types of medical care.
Is it possible to open a center with ultrasound only?
Yes. If the facility provides only ultrasound diagnostic services, the license is issued taking into account the relevant specialty and the requirements for the material and technical base.
Do I need a medical director?
If the diagnostic center operates as a legal entity (e.g., LLC), the issue of the medical director position is resolved according to the organizational structure of the institution and legislative requirements.
Can new types of diagnostics be added later?
Yes. If the center plans to expand the list of specialties or types of medical care, an application to expand the economic activity in medical practice is submitted to the Ministry of Health along with the necessary documents.
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