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.
Selective Control and the Notification Regime
Selective control is exercised only over activities subject to notification, and it is conducted three times a year; in this case the general restrictions of the Law on Control of Entrepreneurial Activity do not apply (Article 63, parts 5 and 6). Where a provider conducts an activity covered by a license or permit, it may operate without notification, provided its license or permit conditions encompass the requirements of the technical regulation and the activity is carried out at a single factual address (part 7).
The accessibility of the technical regulation to interested persons must be ensured in the manner established by Georgian legislation — a principle stated directly in the law and an important orientation for importers and distributors: before supplying a device, it is essential to establish whether the target activity falls under the technical regulation and the corresponding standards.
Practical Tasks for Importers and Distributors
For importers and distributors of medical equipment, three practical conclusions follow from this framework. First, a device that constitutes a measuring instrument is subject in Georgia to type approval, entry into the registry and the procedures established by legislation. Second, equipment used in high-risk medical activity must satisfy the requirements of the technical regulation; otherwise the customer's activity will be suspended and the sale of the device effectively blocked.
Third, procurement specifications for medical equipment and instruments should reflect the quality and safety standards developed by the Ministry together with the relevant bodies. Carrying out this check before concluding a contract substantially reduces the compliance risk under health care legislation.
Frequently Asked Questions
Is there a separate law on medical devices?
No. The regulation is built on the norms of the Law on Health Care and subordinate acts adopted on its basis: the procedure for design, production, operation and repair (Article 66), the standards (Article 67) and the technical regulation of high-risk activity (Article 63).
What happens if the regulation is violated?
If the violation threatens human life and health or the epidemiological situation, the competent body suspends the activity fully or partially and applies to the court within 24 hours; otherwise the decision lapses. After elimination of the violations, an on-site inspection is conducted within 5 working days upon the operator's application.
How often is selective control carried out?
High-risk medical activity is inspected by selective control three times a year, and only over activities subject to notification (Article 63, parts 5 and 6).
Who approves quality and safety standards?
The Ministry, together with the relevant state bodies, develops and implements the quality and safety standards for medical technical products and technologies (Article 67).
How We Help on Legal.ge
The Legal.ge team assists importers, distributors and medical institutions in calculating the requirements connected with medical devices: checking whether a product falls under the measuring-instrument regime, assessing compliance with the technical regulation and preparing procurement contracts. We evaluate your risks and support you in interactions with control bodies. Contact us to discuss your specific situation.