Free Georgia medical device classification tool

What the Georgia classifier checks

How are medical devices classified in Georgia?

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) uses a risk-based framework. Possible classes include Class I — low risk, Class IIa — medium risk, Class IIb — increased risk, Class III — high risk. Georgia's only in-force device class axis is Annex No. 1.1 to the medical-device clinical-investigation technical regulation approved by Government Decree No. 386 of 3 October 2023, which classifies medical devices — the definition includes in vitro diagnostic products, reagents included — into classes I, IIa, IIb and III on rules reproduced from the European model, with the usual duration-of-use and invasiveness distinctions. The class decides the clinical-investigation registration route: for classes IIa, IIb and III the Agency registers a clinical investigation only on the positive recommendation of the Coordination Council for clinical investigations of medical devices, while for the other classes the certificate is issued by Agency decision. General medical goods are not registered as devices at all, so the class axis does not gate market placement. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Georgia classifier use?

Current official LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) classification requirements. Your result includes an explanation and links to the official sources used.

Is the result an official LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.