Georgia Medical Device Market Surveillance under Resolution No. 278: Unannounced Inspections and Standing Readiness

1. Key takeaways

The legal foundation of medical device post-market surveillance in Georgia is Government Resolution No. 278 of August 1, 2023, which approves the procedures, rules and conditions of control in the field of medical and pharmaceutical activities, adopted pursuant to the Law of Georgia on Healthcare. The resolution empowers the regulatory authority to conduct unannounced inspections, carried out in two forms: on-site inspections and documentary inquiries, and it authorizes the imposition of fines and the suspension of activities. For medical device manufacturers, importers and authorized representatives placing products on the Georgian market, the practical consequence is clear: compliance must be demonstrated at any moment, without advance preparation time. A company that can only assemble its compliance evidence after receiving a notification is structurally unprepared for the regime that Resolution No. 278 establishes. The resolution also links inspection outcomes to tangible sanctions, which means that a failed inspection can escalate beyond administrative findings into financial penalties and, in serious cases, suspension of the regulated activity itself. Because the resolution covers the entire field of medical and pharmaceutical activities rather than medical devices alone, inspections of a device distributor may be conducted by the same authority and under the same procedural rules that apply to pharmacies, clinics and pharmaceutical wholesalers, which raises the frequency of contact between device companies and inspectors well above what a device-only regime would produce.

2. Legal basis

1. Government Resolution No. 278 of August 1, 2023 of Georgia: approves the procedures, rules and conditions of control in the field of medical and pharmaceutical activities, adopted pursuant to the Law of Georgia on Healthcare.
2. Law of Georgia on Healthcare, Law No. 6000, March 21, 2008: Article 66 (design, production, maintenance and repair to be carried out according to statutory procedures) and Article 67, paragraph 1 (the ministry establishes quality and safety standards).
3. Code of Georgia on Product Safety and Free Movement, Law No. 6157-Iს, May 8, 2012: Article 2, paragraph 1, subparagraph g (advancement of quality infrastructure and market surveillance systems) and Article 3¹ (national market surveillance strategy, added by Law No. 1447 of April 1, 2026, effective June 1, 2026).
4. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 (August 10, 2009), Article 11¹⁰, paragraph 6: cancellation of registration and removal from the sectoral register.
5. Source note: the number and date of Resolution No. 278 are verifiable; the specific content of its provisions, including inspection triggers, fine amounts and procedural deadlines, is drawn in this topic from secondary public sources and the corresponding article numbers of the original text on matsne have not yet been obtained; relevant figures are therefore marked as practical estimates.

3. Expert insights

Insight one: Resolution No. 278 and Article 3¹ together form a two-layer structure of enforcement power plus enforcement strategy. Resolution No. 278 grants the concrete enforcement tools, namely inspections, fines and suspension, while Article 3¹ requires the government level to prepare a national market surveillance strategy on a regular basis and to define priority areas. The former answers whether the authority can inspect; the latter answers what gets inspected first. Taken together, the two instruments show that Georgian post-market regulation is moving from fragmented practice toward a systematized framework, and companies should expect inspection intensity to grow rather than shrink in the coming planning cycle.

Insight two: unannounced inspections change how companies must prepare. A conventional compliance system can be tidied up in a rush before a scheduled inspection; responding to an unannounced inspection requires a standing state of documentary readiness. This shifts the nature of compliance investment from project-based to operational. It requires permanent staffing and a fixed budget line, rather than a team that is assembled for a registration project and dissolved once the certificate is obtained. Organizations that treat Georgian market compliance as a one-off project will find that their evidence base decays precisely when it is most likely to be requested.

Insight three: cancellation of registration is a heavier consequence than a fine. Article 11¹⁰, paragraph 6 of Law No. 1586 provides that the authority may cancel a registration and remove the product from the sectoral register. A fine is a one-time cost; cancellation terminates the legal basis for selling the product in Georgia and can cascade into tender performance failures and distributor contract breaches. The bottom-line objective of post-market compliance should therefore be framed as preserving the register entry, with fines treated as a secondary, financial dimension of the same risk.

Insight four: the secondary-source status of the procedural detail shapes how legal advice should be written. Because the fine amounts, inspection triggers and procedural deadlines cited from secondary sources have not yet been matched to article numbers in the original text published on matsne, contracts, distribution agreements and internal SOPs should cite the resolution by number and date only, describe the substantive obligations, and flag every quantitative element as a practical estimate pending verification. When the original article numbers are confirmed, the documents can be updated in one controlled revision rather than renegotiated clause by clause.

The Law of Georgia on Healthcare of March 21, 2008 supplies the enabling framework: Article 66 requires that the design, production, maintenance and repair of medical devices follow the procedures established by law, and Article 67, paragraph 1 delegates to the ministry the establishment of quality and safety standards. The Code of Georgia on Product Safety and Free Movement completes the picture from the general product safety side, with Article 2, paragraph 1, subparagraph g mandating the advancement of quality infrastructure and market surveillance systems, and Article 3¹, added by Law No. 1447 of April 1, 2026 and effective June 1, 2026, anchoring the national market surveillance strategy. Read together, these instruments leave no gap in which a device company could argue that post-market oversight is somehow outside the Georgian legal order.

4. Practical recommendations

1. Build a standing document readiness list covering registration certificates, register records, label specimens, complaint logs, vigilance records and maintenance and repair records, all retrievable on demand.
2. Designate a fixed post-market compliance owner whose role does not end when a project closes, and record the delegation in an internal procedure so the responsibility survives personnel changes.
3. Maintain the document readiness list in both electronic and physical form, indexed so that any single record can be produced during an inspection without searching.
4. Track the priority areas defined under the national market surveillance strategy established by Article 3¹ and direct compliance resources toward high-priority areas.
5. Set maintenance of register status as the bottom-line KPI of post-market compliance, assessed alongside fine exposure.

5. Verification checklist

• □ Standing document readiness list established and an owner assigned
• □ Post-market compliance role made permanent and budgeted
• □ Priority areas of the national market surveillance strategy tracked
• □ Register status maintenance set as a bottom-line KPI
• □ Inspection response card distributed to warehouse and distribution staff
• □ Original article numbers of Resolution No. 278 listed as pending verification

Regulatory information verified as of October 30, 2026

This English edition is provided by GRZAN, the international regulatory translation service of the GRZAN global compliance desk. GRZAN translates medical device regulatory guidance for manufacturers, importers and authorized representatives preparing documentation for Eurasian, Caucasian and EU-aligned markets. For translation, regulatory monitoring or compliance support inquiries, contact info@grzanglobal.com.