The Concept of a Medical Institution and Its Criteria
Opening a diagnostic centre in Georgia begins with the legal concept of a medical institution. Under the law, a medical institution is a legal entity of an organisational and legal form permitted by Georgian legislation that carries out medical activity in the prescribed manner. This definition has practical weight: the centre must be registered as a legal entity and its medical status properly formalised.
Together with the concept, the law sets financial criteria that essentially define the status of a medical institution. The share of income derived from medical activity in the financial resources of the institution 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 for carrying out the medical functions. In addition, 100% of the income received from medical services and other economic activity performed under internal standards remains at the disposal of the institution, while the salary fund must constitute not less than 30% of that income.
The Functions of a Medical Institution and Its Obligations
The law defines the functions of a medical institution: determining the state of a patient’s health; prophylaxis, treatment, rehabilitation or palliative care; midwifery activity; pharmaceutical activity; pathologoanatomic examination and forensic medical expertise; and epidemiological control measures. For a diagnostic centre the first of these — determining the state of health — is central and defines its profile. At the same time, the institution is obliged to provide emergency medical care to a patient in the cases provided for by law, 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 and Permit: Which Document Is Needed When
In the sphere of medical activity, the document confirming the relevant right — a licence and/or a permit — is issued by the ministry. The rule is clear: activity subject to licensing or permitting may not be carried out without the appropriate licence and/or permit. The personnel question is equally important: the list of health-care personnel with the right of employment in a medical institution and with appropriate education is approved by the minister. Each service must also be analysed separately: some activities require a licence, others a permit, and yet others fall under a notification regime.
High-Risk Medical Activity and the Notification Regime
Particular attention is devoted to medical activity carried out on an outpatient basis or in the conditions of a day station and involving high risk. Such activity is regulated by the technical regulation of medical activity and is subject to mandatory notification to the ministry. The list of high-risk medical activities is determined by a decree of the Government of Georgia, and the technical regulation — which contains requirements concerning medical equipment, instruments, hygienic conditions and the maintenance of medical documentation — is adopted by government decree as well.
Compliance with the technical regulation is verified by selective control, and such control is carried out three times a year. Where violations are detected that threaten human life or 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 technical regulation are satisfied. In that case the body must submit to the court, within 24 hours of taking the suspension decision, 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, the body verifies compliance on site within 5 working days and issues an act. Where a provider already holds a licence or permit whose conditions cover the requirements of the technical regulation and the activity is carried out at a single factual address, the provider may conduct the relevant activity without a separate notification.
Frequently Asked Questions on Diagnostic Centre Licensing
Which authority issues the licence for a diagnostic centre?
In the sphere of medical activity the confirming document — a licence and/or a permit — is issued by the ministry. Which document a particular service requires depends on the classification of the specific list of services the centre intends to provide.
Which financial indicators must a medical institution observe?
The share of income from medical activity in the financial resources must reach not less than 75%, and not less than 75% of the average annual value of fixed assets must serve the medical functions. Of the income, 100% remains at the disposal of the institution, while the salary fund must constitute not less than 30% of the income.
What is the regime of high-risk medical activity?
Such activity is carried out on an outpatient or day-station basis, is governed by a technical regulation and requires mandatory notification to the ministry. The list is determined by government decree, and compliance is verified by selective control conducted three times a year.
How do suspension and restoration of activity take place?
Where a threat arises, the body suspends the activity and must submit a motion to the court within 24 hours; if it fails to do so, the decision is revoked. After the violation is eliminated, an on-site inspection is carried out within 5 working days and an act is issued, followed by a decision on the merits.
How We Help on Legal.ge
Licensing a diagnostic centre combines several regulatory axes: the legal form, financial criteria, the personnel list and the choice of authorisation regime. The Legal.ge team will help you arrange these axes into a single plan: we will assess your profile, define the required authorisations, prepare the notification and the compliance file, and represent you in dealings with the ministry. Contact us — your centre will stand on a complete legal foundation.