Medical Device Regulation in Georgia: Market Overview, Registration Procedures, and Regulatory Compliance

Regulatory Authority

State Regulation Agency for Medical Activities, Ministry of Labour, Health, and Social Affairs

Link for Ministry of Health

Ministry of Health (Georgia) | GHDx (healthdata.org)

Listing or Registration Requirements

Registration of medical devices in Georgia is not required, but prior to importation and marketing it would be necessary to obtain a letter from the Ministry of Labor, Health and Social Affairs of Georgia related to product classification.

Documents Required for Georgia Medical Device Registration

The registration process for dental materials, test systems, allergens, and reagents follow a similar procedure as that for medicinal products. According to the Law “On Medicinal Products,” registration can be conducted through either the national procedure, which takes 2 months, or the recognition procedure, with a registration period of 15 calendar days. The submission of documents aligns with an approved list.

License Validity

The Marketing Authorization is granted for a duration of 5 years

License Renewal

In the case of a renewal procedure, applicable solely to products registered through the national procedure, documentation from the approved list must be submitted no later than 2 months before the expiration of the Marketing Authorization. The procedure typically spans 1 month, excluding the time allocated for responding to comments, which is 2 months.

Special Labelling Requirements

Official documents, in English or Russian and bearing the original seal and signature from the manufacturer, are submitted for translation into Georgian, followed by notarization. Technical and clinical components are exclusively submitted in electronic format, available in English or Russian, with instructions from the manufacturer in the original, featuring a seal and signature, and provided in English, Russian, or both.

Who should make this communication?

Manufacturer

When to make this communication?

Before placing a medical device into the market.

Market Overview

The anticipated revenue for the Medical Devices market in Georgia is forecasted to reach US$134.20 million in 2024. Among the diverse market segments, US$21.25 million is expected to be the largest, contributing to a market volume of US$181.90 million in the same year.

Looking forward, the industry is poised to undergo a consistent annual growth rate (CAGR 2024-2028) of 7.90%, leading to a projected market volume of US$181.90 million by 2028. It is noteworthy that, on a global scale, the United States is predicted to be the highest revenue generator, reaching US$182.00 billion in 2024. The medical devices market in Georgia is witnessing a surge in demand, particularly for advanced diagnostic equipment.