Georgia (Caucasus)

The primary regulatory authority for health products in Georgia is the National Agency for Pharmacy and Medical Technologies (NAPM), operating under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia. The main governing legislation includes the Law of Georgia on Medicines and Pharmaceutical Activities, the Law on Medical Devices, and a series of subordinate decrees and technical regulations that establish requirements for registration, quality control, and post-market surveillance. All medical devices, diagnostics, pharmaceuticals, and increasingly digital health solutions must undergo a formal registration or conformity assessment process administered by NAPM before they may be legally placed on the Georgian market. The general approval process involves submission of a dossier, review by NAPM technical experts, and, where required, laboratory testing or inspection of manufacturing facilities.

Georgia has progressively aligned its regulatory framework with international standards, reflecting its aspirations under the EU-Georgia Association Agreement and the Deep and Comprehensive Free Trade Area (DCFTA). For pharmaceuticals, submissions are accepted in Common Technical Document (CTD) format, and products already registered by stringent regulatory authorities such as the EMA, US FDA, or Health Canada may benefit from an accelerated or simplified registration pathway. A local representative or authorized person registered in Georgia is required for foreign manufacturers seeking market authorization. For medical devices, the framework draws on EU Medical Device Regulation (MDR) principles, with conformity assessment requirements scaled to risk class. Notable recent reforms include the strengthening of pharmacovigilance obligations, the introduction of a medical device unique device identification (UDI) framework, and growing regulatory attention to software as a medical device (SaMD) and digital health tools, though dedicated digital health legislation remains under development.

Public procurement of health products in Georgia is coordinated primarily through the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs, with the Social Service Agency (SSA) playing a central operational role in purchasing medicines and services under state health programs. Tender procedures are governed by the Law of Georgia on Public Procurement and administered via the State Procurement Agency (SPA), which operates the unified electronic procurement platform (e-procurement). Centralized state programs covering essential medicines, oncology treatments, tuberculosis, HIV/AIDS, hepatitis C, and immunization are the dominant channels for public-sector health product purchases, with contracts awarded primarily on the basis of price competition. Georgia does not currently enforce strong local manufacturing preference policies in public tenders, though domestically produced products meeting quality standards may compete on equal footing.

The private healthcare sector in Georgia is well-developed relative to regional peers, with a significant share of health expenditure flowing through private hospitals, pharmacies, and distribution networks, creating a meaningful commercial procurement channel for health product suppliers. International donor and multilateral organizations also play an important role: the Global Fund to Fight AIDS, Tuberculosis and Malaria has historically funded procurement of diagnostics and medicines for HIV and TB programs; USAID and its implementing partners have supported health system strengthening and commodity supply initiatives; and UNICEF has been involved in vaccine and child health supply procurement. Gavi, the Vaccine Alliance has supported Georgia's immunization program, influencing vaccine procurement standards and cold-chain requirements. Suppliers engaging with donor-funded channels typically must demonstrate compliance with WHO prequalification, stringent regulatory authority approval, or equivalent quality assurance standards, which effectively sets a higher bar than domestic registration alone.