Registration of medical devices in Georgia

Medical devices require mandatory state registration and obtaining a registration certificate, if subject to registration, in accordance with the current legislation of Georgia. Registration gives the right to import, sell, and use the product throughout the territory of Georgia.


What types of medical devices need to be registered?

According to Law of Georgia No. 1586 dated 10 August 2009 on Medicines and Pharmaceutical Activities, the following medical devices are subject to state registration in Georgia:

  • Dental materials
  • Mechanical contraceptives

Registration stages:

Preparation of the registration dossier
Preliminary analysis of the registration dossier
Import of samples of medical devices
Submission to the authorised body of an application for registration of the medical devices, as well as of the registration dossier and the samples (filing the application for the procedure)
Primary expert examination (administrative expert examination)
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