Georgia Medical Device Clinical Trial Pathway under Resolution No. 386: Four Conditions to First Patient

1. Key takeaways

The complete compliance pathway for medical device clinical trials in Georgia is defined by Government Resolution No. 386 of October 3, 2023, the Technical Regulation on the Conduct of Clinical Trials of Medical Devices. Four conditions must be satisfied simultaneously: a clinical trial registration certificate issued by the regulatory authority, a positive opinion of the local ethics committee of each participating institution, a legal representative registered in Georgia, and protection of the rights of vulnerable groups. The technical regulation expressly references the Declaration of Helsinki, ICH Good Clinical Practice and ISO 14155:2020. Unlike most of the Georgian device framework, which remains principle-level, this pathway is written at the level of checkable conditions, which is why it rewards disciplined project management: each of the four conditions sits with a different actor, and they mature on different schedules.

2. Legal basis

1. Government Resolution No. 386 of October 3, 2023 of Georgia: the Technical Regulation on the Conduct of Clinical Trials of Medical Devices.
2. References of the technical regulation: the Declaration of Helsinki, ICH Good Clinical Practice (GCP) and ISO 14155:2020, the good clinical practice standard for clinical investigation of medical devices for human subjects.
3. Article 4: conditions for conducting a clinical trial, namely issuance of a registration certificate by the authority; a positive opinion of the local ethics committee; a legal representative registered in Georgia; and protection of the rights of vulnerable groups.
4. Purpose of the trial: to evaluate the effectiveness and safety of the medical device and to assess its risk-benefit profile under the intended use.
5. Law of Georgia on Healthcare, Law No. 6000 (March 21, 2008), Articles 66 and 67: the enabling provisions at the level of the parent statute.

3. Expert insights

Insight one: Resolution No. 386 is the only element of this topic for which article-level operational guidance can be given. The statutes governing Georgian device registration are mostly principle-level provisions, whereas this technical regulation specifies the condition list, the document list and the referenced international standards. This makes clinical trials the most deterministic part of Georgian device compliance work: its rules are written down. A sponsor can build a project plan directly against Article 4 and the document list, assign owners and dates, and know in advance what a complete dossier looks like, something that is not yet possible for other compliance segments in Georgia.

Insight two: the reference to ISO 14155:2020 gives Georgian trial data international usability. Trials conducted to this standard have a foundation of usability in regulatory systems that accept foreign GCP standards, for example the acceptance of foreign data by the United States FDA under 21 CFR 812.28. This is the substantive value of Georgia as a trial location: data generated there can travel. It also explains why the country has accumulated practical experience in early feasibility studies in the cardiovascular field, where international sponsors seek fast, GCP-compliant sites outside saturated EU networks.

Insight three: protection of vulnerable groups is listed as a stand-alone condition. Article 4 places this item alongside the registration certificate, the ethics opinion and the legal representative, which shows it is not an appendix to the ethics opinion but an independently reviewed matter. The trial protocol must contain a dedicated chapter identifying vulnerable groups and the protective measures applied to each, and the ethics committee can be expected to assess that chapter on its own merits rather than as part of a general beneficence discussion.

Insight four: the trial purpose clause anchors the scientific framing of the dossier. The regulation defines the purpose of the trial as evaluating the effectiveness and safety of the medical device and assessing its risk-benefit profile under the intended use. This wording aligns with ISO 14155:2020 conventions and should be mirrored in the protocol synopsis, the investigator brochure and the patient-facing materials, so that every layer of the dossier states the same objective in the same terms. Consistency of purpose across documents is one of the few review criteria that can be checked mechanically, and mismatches here generate avoidable queries during ethics review.

The parent statute explains why this pathway exists at all. Articles 66 and 67 of the Law of Georgia on Healthcare of March 21, 2008 require that devices be designed, produced, maintained and repaired according to statutory procedures and delegate the setting of quality and safety standards to the ministry. The 2023 technical regulation is the concrete exercise of that delegation for clinical evidence, which is why its rules are more detailed than anything else in the Georgian device framework. Sponsors can treat the regulation as the template of what full implementation of the coming device statute will look like: condition lists, document lists, referenced standards and defined responsibilities, all in one instrument.

4. Practical recommendations

1. Sequence the project: first appoint the legal representative, then obtain the ethics opinions of each participating institution, then submit the registration certificate application.
2. Write the protocol to ISO 14155:2020 and attach a notarized Georgian translation.
3. Include a separate chapter on identification and protection of vulnerable groups, answering the requirement of Article 4 directly.
4. Design data management to international GCP standards so that data usability is preserved for later filings outside Georgia.
5. Keep a single master tracker mapping every document to its responsible party and its current status, refreshed weekly during preparation.

5. Verification checklist

• □ Legal representative appointed and registered in Georgia
• □ Positive opinions of the local ethics committees of all participating institutions obtained
• □ Protocol written to ISO 14155:2020 with notarized Georgian translation completed
• □ Vulnerable groups protection chapter established as a stand-alone section
• □ Data management plan designed to international GCP standards
• □ Master document tracker maintained and refreshed weekly

Regulatory information verified as of October 30, 2026

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