The Statutory Framework for Medical Devices
Georgia has no separate statute dedicated to medical devices: their regulation rests on the Law of Georgia on Health Care. Under this law, the design, production, operation and repair of medical technical products are carried out according to the procedure established by legislation (Article 66). This means that the entire life cycle of a device — from design to repair — is governed by specific rules, and their neglect entails liability determined by Georgian legislation.
At the level of standards, the Ministry, together with the relevant state bodies, develops and implements quality and safety standards for medical technical products and medical technologies (Article 67, part 1). The type approval of measuring instruments, their entry into the registry, and their import and production are carried out in accordance with Georgian legislation (part 2) — which makes type approval a directly practical task for importers of devices with a measuring function.
The Technical Regulation of High-Risk Medical Activity
Medical activity carried out on an outpatient or day-stationary basis that involves high risk is regulated by the technical regulation of medical activity and is subject to mandatory notification to the Ministry (Article 63, part 1). The list of such activities is determined by a decree of the Government of Georgia, and the technical regulation itself is adopted by government decree and contains requirements concerning the production of medical equipment and instruments, hygienic conditions and medical documentation (parts 2 and 3).
Compliance with the regulation is verified through selective control, according to rules approved by an order of the Minister, and non-compliance entails liability established by Georgian legislation (part 4). The mandatory notification form must contain the name of the activity, the identification data of the person, its address and contact information; the form may also be completed electronically, and the form and the rule are approved by the Minister, including a different notification deadline for existing providers (parts 8–10).
Suspension of Activity and Judicial Control
Where violations are revealed during the inspection of compliance with the technical regulation and a threat arises to human life and health and/or to the epidemiological situation, the competent body of the Ministry is authorized to suspend the high-risk medical activity fully or partially until the conditions of the regulation are satisfied. In doing so the body must, within 24 hours of adopting the suspension decision, submit to the court an application for approval of the suspension; if the application is not submitted within that period, the decision is deemed revoked and the activity restored (Article 63, part 4¹).
After the violations have been eliminated, upon the application of the person entitled to conduct the activity, the competent body checks on-site, within 5 working days, the fact of compliance with the conditions of the regulation, issues an inspection act and decides on revoking the suspension (part 4²). A reasoned decision to refuse revocation must be delivered to the interested party immediately and may be appealed in court (part 4³). This sequence — suspension, judicial approval, re-inspection, revocation — gives operators a clearly structured path back to lawful operation.