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.