Georgia medical device regulations

საქართველოს მთავრობის 2024 წლის 7 ოქტომბრის №334 დადგენილება, in force on publication. Adds paragraphs 3–5 to Art. 7 of the Technical Regulation approved by Decree No. 386 (Annex No. 1): the requirement of para. 2 does not apply to a clinical investigation carried out in a country recognised by Government Decree No. 188 of 22 October 2009 where the device is an analogue/substitute of the same manufacturer's already registered device with improved technical characteristics, the previous generation is on the market of a recognised country, and the country of manufacture is on that same list. Para. 4 adds the documents the applicant must file (opinion of an authoritative professional association, recommendation of the Georgian National Bioethics Council, informed-consent form) and para. 5 assigns the decision to the Minister or a specialist group. Two articles only.

საქართველოს მთავრობის 2023 წლის 3 ოქტომბრის №386 დადგენილება. Approves the Technical Regulation on the clinical investigation of medical devices (Annex No. 1) and, as Annex No. 1.1, the rules for classifying medical devices, including the definitions of transient, short-term and long-term use. Art. 2 defines the Ministry and the Agency, the latter as the public-law legal entity under the Ministry's state control — სამედიცინო და ფარმაცევტული საქმიანობის რეგულირების სააგენტო. Ingested in Georgian from matsne.gov.ge document 5934377, the version published 04/10/2023; the amended consolidated view is behind matsne's paid consolidated-version service, so the 2024 amendment is carried as its own expression.

საქართველოს შრომის, ჯანმრთელობისა და სოციალური დაცვის მინისტრის 2012 წლის 12 ივნისის №01-34/ნ ბრძანება. Art. 1 lists, item by item, the ministerial acts declared no longer in force; item შ) is the 10 December 2003 Order No. 318/ნ on the state registration of medical technical devices. Ingested because it is the instrument that ends the market's earlier device-registration rule, and its own list is the evidence for that repeal.

Consolidated English text, current to 30/11/2023 (the most recent consolidated publication the matsne page lists), of the Law of Georgia on Medicines and Pharmaceutical Activities, Chapters I–XIII (several chapters, e.g. VII, IX, XI and XII, are marked "(Deleted)") and Arts. 1–38. Read against the Georgian view of the same document, this instrument is a medicines and pharmaceutical-activity law: its chapters cover pharmaceutical products, manufacturing, sale, substances under special control and side-effect monitoring. It is not a general device law, but it does reach three device-type categories: Art. 1^1(12) defines medical goods, Art. 1(4) exempts non-invasive contraceptive mechanical devices, Art. 11^11(19)(d) names dental material, invasive contraceptive mechanical devices and diagnostic products as products registered within the pharmaceutical regimes, and Art. 11^11(20)(i)-(k) sets their dossiers; the registration clocks (Art. 11^11(9)), validity and variation rules of those regimes therefore apply to them, while instruments and devices as such stay outside the Law.

საქართველოს შრომის, ჯანმრთელობისა და სოციალური დაცვის მინისტრის 2003 წლის 10 დეკემბრის №318/ნ ბრძანება. Approved the rules for the state registration of medical technical devices (Annex No. 1, Arts. 1–8): general provisions, terms and definitions, the registration fee, the registration sequence, the sequence for re-registration and modernised models, notification of changes to the documentation of registered devices, and cancellation of registration. The order was to enter into force on the 90th day after publication. Repealed with effect from 13/06/2012 by Order No. 01-34/ნ; the instrument is ingested because it is the market's earlier registration rule and the repeal instrument names it verbatim.

Consolidated English text, current to 01/04/2026, of the Product Safety and Free Movement Code, Chapters I–X and Arts. 1–104. It is the general product-safety framework: responsibility for placing defective products on the market, general product-safety requirements, technical-threat control, technical regulations (Arts. 56–58 provide for their approval and for market surveillance), standardisation, traceability of measurements, conformity assessment, accreditation, and transitional and final provisions. The text names no medical device; it is the enabling framework under which the device technical regulations are approved, not a device-naming instrument.