On October 3, 2023, the Georgian Government passed Resolution no. 386, focusing on the Technical Regulation for the implementation of clinical research of medical devices.

This Technical Regulation aligns with the Declaration of Helsinki and incorporates the latest changes and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice (GCP). It also adheres to the Standards and Guidelines of the International Organization for Standardization “Involving People in the Clinical Trial of Medical Devices” (ISO 14155:2020).

According to the Regulation, a clinical trial aims to evaluate the effectiveness and safety of a medical device, along with assessing the risk-benefit ratio for its intended usage. The clinical trial registration certificate, issued by the Agency, is made public on the Ministry and Agency’s websites within 20 working days after the application’s submission.

Shota Jibuti, GCT Managing Director in Georgia commented: “I am more than glad that the new legislation has been released for regulation of Medical Devices related clinical trials in Georgia. This remarkable fact gives us an opportunity to spread our knowledge, competence, and thoroughness in this direction too.”

Article 4 outlines conditions for conducting a clinical trial, including requirements such as the issuance of a registration certificate by the Agency, a positive opinion from the Local Ethics Committee, the presence of a Legal Representative registered in Georgia, and protection of the rights of vulnerable populations.

The Regulation covers various aspects, including methods of conducting clinical research, requirements for trial subjects, and terms and conditions for submitting applications for registration. The following documents are currently required to be submitted as a part of the dossier:

  1. Application and registration payment receipt
  2. Power of attorney issued by the Sponsor – original document/apostilized or legalized and notarized by a foreign country
  3. Clinical trial plan and clinical trial protocol – in accordance with the GCP, with a notarized Georgian translation. Pre-clinical trial materials.
  4. Sample of the clinical trial subject’s information sheet and written informed consent form along with a notarized translation into Georgian
  5. CRF
  6. A copy of the document confirming the risk/responsibility of the clinical trial
  7. A document confirming the production according to the relevant standard must be submitted for the medical device to be used in the trial
  8. Written consents of the director and clinical manager of the medical institution(s) participating in the clinical trial
  9. A substantiated positive conclusion of the local independent ethics committee of each medical institution participating in the clinical trial.