---
title: "Medical Device Regulations"
url: "https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/medical-device-regulations-952-en"
field: "Healthcare & Pharmaceutical Law"
description: "Medical devices under Georgia's Health Care Law: quality standards, the technical regulation and selective control three times a year. Legal.ge."
reviewed: "2026-06-27"
updated: "2026-10-24"
publisher: "legal.ge"
---

# Medical Device Regulations

> Source: legal.ge, https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/medical-device-regulations-952-en

## 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 full text is available on legal.ge after signing in: https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/medical-device-regulations-952-en

### Is there a separate medical device law?

No. Regulation rests on the Law on Health Care and subordinate acts: the production and operation procedure, quality and safety standards, and the technical regulation of high-risk medical activity.

### What happens on violation?

The competent body suspends the activity and applies to the court within 24 hours, failing which the decision lapses; after the violations are eliminated, an on-site inspection follows within 5 working days.

### How often does selective control occur?

Three times a year, only over activities subject to notification. Licensed providers may in certain cases operate without notification.

### Who approves the standards?

The Ministry, together with the relevant state bodies, develops and implements quality and safety standards for medical technical products and technologies.