The Legal Form and Status of a Medical Clinic
Opening a medical clinic begins with the choice of legal form. The law provides that a medical institution may be an entrepreneurial or a non-entrepreneurial legal entity: an entrepreneurial medical institution carries out its activity in accordance with the Georgian law on entrepreneurs, while a non-entrepreneurial one acts in accordance with Georgian legislation generally. The concept of the clinic as a medical institution is precisely defined by law: it is a legal entity of an organisational and legal form permitted by Georgian legislation that carries out medical activity in the prescribed manner.
Together with the status, the law sets financial boundaries. The share of income derived from medical activity in the financial resources of the clinic must amount to not less than 75%, and not less than 75% of the average annual value of the fixed assets on its balance must be allocated to the medical functions. Compared with the previous year, 100% of the income received from medical services performed under internal standards and from other economic activity remains at the disposal of the institution, while the salary fund must constitute not less than 30% of that income.
The Functions of the Clinic and Its Duties Towards Patients
The law enumerates the functions that a medical institution may perform: determining the state of a patient’s health; prophylaxis of diseases, treatment, rehabilitation or palliative care; midwifery activity; pharmaceutical activity; pathologoanatomic examination of corpses and forensic medical expertise; and the carrying out of epidemiological control measures. At the same time, the law obliges the clinic to provide emergency medical care to a patient in the cases provided for, to observe the standards, rules and norms established by the legislation regulating medical and pharmaceutical activity, and to ensure equal accessibility of the institution for persons with disabilities.
Licence, Permit and Their Cancellation
In the sphere of medical activity the document confirming the relevant right — a licence and/or a permit — is issued by the ministry, and the list of health-care personnel with the right of employment in a medical institution and with appropriate education is approved by the minister. The rule is unambiguous: medical activity that under Georgian legislation is subject to licensing or permitting may not be carried out without the appropriate licence and/or permit. The procedure for the cancellation of a licence or permit for the relevant medical activity is determined by the Georgian law on licences and permits. When planning a clinic each service must also be classified: some services are fully licensable, others are covered by a permit, and still others fall under the mandatory notification regime.
High-Risk Services and Selective Control
High-risk medical activity carried out by the clinic on an outpatient basis or in the conditions of a day station is regulated by a technical regulation and is subject to mandatory notification to the ministry. The list of such activities is determined by a decree of the Government of Georgia, and the technical regulation contains requirements concerning medical equipment, instruments, hygienic conditions and the maintenance of medical documentation. Compliance with the regulation is verified by selective control, in accordance with rules approved by the minister’s order, and this control is carried out three times a year.
Where the control reveals violations that threaten life, health or the epidemiological situation, the competent body of the ministry is entitled to suspend the activity, fully or partially, until the conditions of the regulation are satisfied. In that case the body must, within 24 hours of taking the suspension decision, submit to the court a motion for approval of the suspension; if the motion is not submitted within that period, the decision is considered revoked and the activity restored. After the violations are eliminated, at the applicant’s request, the body verifies compliance on site within 5 working days and issues an inspection act. A holder of a licence or permit whose conditions cover the requirements of the technical regulation and who operates at a single factual address may conduct the relevant activity without a separate notification.
Frequently Asked Questions on Medical Clinic Licensing
Which legal form may a clinic have?
A medical institution may be an entrepreneurial or a non-entrepreneurial legal entity. The entrepreneurial form operates under the rules of the law on entrepreneurs, the non-entrepreneurial one under the general rules of Georgian legislation. The choice is reflected in tax and governance consequences.
What financial conditions attach to the medical status?
The share of income from medical activity in the financial resources must be not less than 75%, and 75% of the fixed assets must serve the medical functions. Of the income, 100% remains with the clinic and the salary fund must be not less than 30% — these conditions are an essential part of the status.
How are services distributed between licence, permit and notification?
The licence and/or permit is issued by the ministry, while high-risk outpatient services fall under the notification regime and the technical regulation. The status of each service is determined by its list entry, so the classification must be analysed before the application.
What happens if a violation is discovered during control?
In case of a threat, the body suspends the activity and submits a motion to the court within 24 hours; if it fails to do so, the decision is revoked. An on-site inspection within 5 working days then follows, with an act.
How We Help on Legal.ge
Licensing a medical clinic requires the legal form, the financial criteria, the personnel and the authorisation regime to be brought into harmony simultaneously. The Legal.ge team will help you achieve that harmony: we will select the form, map out the licence and permits, prepare the notification and the compliance dossier, and support you in verifying the personnel list. Contact us — your clinic will pass licensing with a precise plan.