The Legal Form and Standards of a Medical Institution
A medical institution is a legal person of an organizational and legal form permitted by Georgian legislation that carries out medical activity in the established manner. The law describes this status through strict quantitative criteria: the share of income from medical activity in the financial resources of the institution must be at least 75 percent, and at least 75 percent of the average annual value of the fixed assets on its balance must be allocated to the performance of medical functions. The full amount of income received from services performed under internal standards remains at the disposal of the institution, while the salary fund must constitute at least 30 percent of income. These requirements ensure that the licensed entity has a genuinely medical orientation rather than being merely formally registered.
The functions of medical institutions are the determination of the patient's state of health; the prophylaxis and, or, treatment of diseases, the rehabilitation of patients and, or, palliative care; obstetric activity; pharmaceutical activity; the pathological anatomical examination of corpses and forensic medical examination; and the carrying out of epidemiological control measures. The institution is obliged to provide emergency medical care to the patient in the cases provided by law, to observe the standards, rules and norms regulating medical and pharmaceutical activity, and to ensure equal accessibility of the institution for persons with disabilities.
Licence, Permit and the Personnel List
In the sphere of medical activity, the document confirming the corresponding right — a licence and, or, a permit — is issued by the relevant ministry. The list of health care personnel with the right of employment and the corresponding education is approved by the minister. The licensing process thus unfolds on two levels: the right confirming document and the control of the qualifications of personnel.
High Risk Medical Activity
Where medical activity carried out on an outpatient or day clinic basis contains high risk, it is regulated by a technical regulation and is subject to mandatory notification to the ministry. The list of such activities and the technical regulation are determined by a government decree; the regulation contains requirements concerning medical equipment, instruments, hygienic conditions and the maintenance of medical documentation. Compliance is verified by selective control, three times a year. Where the activity is already covered by a licence or permit, and the licence conditions encompass the requirements of the regulation and the activity is carried on at a single actual address, working without notification is also possible. The notification form may be filled in electronically and must contain the name of the activity, the identification data of the person, the address and contact information.
For the provider this regime creates meaningful flexibility: high risk medical activity does not require licensing — it is sufficient to notify the ministry in the prescribed form and to observe the requirements of the technical regulation. At the same time, the notification is not a mere technical document but a legal safeguard: it establishes the provider's place in the list of specific activities, and thereby defines both the object of inspection and the obligation to comply with the requirements. The regulation must be accessible to interested persons, and it is on this document that an appeal may be grounded — both against the results of an inspection and against a suspension decision.
Suspension and Judicial Control
Where violations are revealed during an inspection and a danger arises to human life, health or the epidemiological situation, the competent body of the ministry is empowered to suspend the activity fully or partially until the conditions of the regulation are satisfied. Within 24 hours of the suspension decision the body must submit to the court a motion to confirm the suspension; if the motion is not submitted within that term, the decision is deemed revoked and the activity restored. After the violations are eliminated, the body, on the basis of an application, verifies compliance on site within 5 working days and issues an inspection act; a substantiated decision to refuse revocation of the suspension is immediately handed to the interested party and may be appealed to court.
Frequently Asked Questions
What must the share of medical income be?
At least 75 percent of financial resources, and at least 75 percent of the average annual value of fixed assets must be allocated to medical functions; the salary fund must be at least 30 percent of income.
Who issues the licence or permit?
The relevant ministry. The list of personnel with the right of employment and the required education is approved by the minister.
How often does selective control take place for high risk activity?
Three times a year. Inspection is possible only with respect to activities subject to notification.
What happens after suspension?
Within 24 hours the body applies to the court to confirm the suspension; after the violations are eliminated, on site verification within 5 working days follows on the basis of an application, with an act issued.
How We Help on Legal.ge
The health law team of Legal.ge assists in obtaining licences and permits, preparing notifications, appealing suspension decisions and interacting with the ministry. Contact us — we will assess your activity and plan the path of ensuring legality.