There is no registration of medical devices in Georgia, with the exception of dental materials and diagnostic tools (test systems, allergens, reagents), but medical devices are certified when imported. Prior to import, we recommend receiving a confirmation (letter) from the Ministry of Health stating that the product planned for import is not a medicinal product and does not need to be registered.
The registration procedure for dental materials, test systems, allergens and reagents is similar to the registration procedure for medicinal products, and, according to the Law “On Medicinal Products”, it can be performed both according to the national procedure (registration period is 2 months) and the recognition procedure (registration period is 15 calendar days); documents are submitted according to the approved list.
Administrative documents are provided in English or Russian, in original, with a seal and signature from the manufacturer. All administrative documents are submitted to the bureau for translation into Georgian, and are notarized. Technical and clinical parts are submitted only in electronic forms in English or Russian.
The instruction is provided from the manufacturer with a seal and signature (original) in English, Russian, or bilingual.
For the national procedure, package labeling information (artworks) is submitted in English, Russian, or bilingual. For the recognition procedure, a packaging layout is submitted and approved; it must correspond to the packaging layout registered and authorized for sale on the pharmaceutical market of the reference country, the registration of which is recognized.
The Marketing Authorization is issued for a period of 5 years.
For renewal procedure (applies only to products registered according to the national procedure), it is necessary to submit documentation on the approved list not later than 2 months before the expiration of the Marketing Authorization. The duration of the procedure is 1 month, not taking into account the period for responses to comments (2 months).
During the period of Marketing Authorization validity, the Applicant may initiate amendment: type IA variations (duration is 20 days), type IB variations (duration is 1 month), type II variations require a new registration.
Cratia provides professional services of state registration of medical devices in Georgia. We have an excellent knowledge of national legislation, necessary experience and resources. We have an excellent knowledge of national legislation, necessary experience and resources.