Georgia Unannounced Inspections of Medical Device Facilities: Duties, Rights and Readiness at Any Hour

1. Key takeaways

Government Resolution No. 278 of August 1, 2023 authorizes the regulatory authority to conduct unannounced inspections of facilities subject to state control at any time of day or night. The core duties of the inspected party are to provide documents in both electronic and physical form, to permit copying, and to give explanations; the core rights are to be informed of the individual administrative legal act on which the inspection is based and of the measures intended to be taken, and to have the rights and obligations of the inspected party’s representative explained. For medical device companies operating warehouses, service centers or distribution points in Georgia, the practical reading is that no location and no shift can be assumed to be outside inspection scope. Readiness is therefore not a legal department task alone: night-shift warehouse staff, weekend duty managers and security personnel all need to know what to do when inspectors arrive without warning.

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; empowers the regulatory authority for medical and pharmaceutical activities to conduct unannounced inspections of facilities subject to state control.
2. Law of Georgia on Healthcare, Law No. 6000, March 21, 2008: Article 63², paragraphs 8, 9 and 10 (mandatory notification forms and electronic submission for providers of high-risk medical activities; ministry approval forms and procedures), reflecting the same legislative tradition that procedures must be documented and explained.
3. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 (August 10, 2009), Article 11¹⁰, paragraph 6 and Article 11¹¹.
4. Source note: the number and date of Resolution No. 278 are verifiable; procedural details of inspections, including the content of notifications, document form requirements, the rule that a representative’s refusal to participate does not halt the inspection, and confidentiality obligations, are drawn from secondary public sources and are pending verification against the article numbers of the original text on matsne; relevant procedural figures are marked as practical estimates.

3. Expert insights

Insight one: the phrase any time of day or night removes the temporal boundary of inspections altogether. Ordinary inspections are constrained by working hours; the wording of Resolution No. 278 means that night shifts and weekends fall squarely within inspection scope. For device companies running 24-hour warehousing or distribution, night-shift staff must possess the same document retrieval capability as daytime staff. This is a substantive training requirement, not a formality, and it should be reflected in shift rosters, on-call procedures and the physical placement of key records at each site.

Insight two: among the duties, the requirement to produce documents in both electronic and physical form is the easiest to overlook. The resolution requires the inspected party to submit documents in electronic and physical form. A company that can only show electronic files loses ground on this specific point. The compliance system should be designed so that any document can be printed within 30 minutes, which in practice means maintaining current printouts of the most frequently requested categories, such as registration certificates, register records and complaint logs, at each inspected site rather than only at headquarters.

Insight three: the core of the rights list is the right to know. Inspectors must identify the individual administrative legal act on which the inspection is based, state the measures they intend to take, and explain the rights and obligations of the inspected party’s representative. The site lead should record each of these elements in the inspection record. This record is the foundation of any later objection or administrative appeal; declining to record what was announced at the site amounts to waiving the remedies that procedural law would otherwise preserve.

Insight four: the procedural detail of Article 63² shows what inspectors themselves must comply with. The Law of Georgia on Healthcare regulates the mandatory notification forms for providers of high-risk medical activities, their electronic submission, and the forms and procedures of ministry approval in paragraphs 8, 9 and 10 of Article 63². Although those paragraphs address regulated facilities rather than inspections directly, they demonstrate the legislative style of the same system: procedural acts must be in prescribed written form and the parties must be told what applies to them. Companies can reasonably expect the same style inside Resolution No. 278, and should therefore insist on documentary identification of the inspection basis at the door, politely and consistently, at every visit.

A practical note on refusal: secondary sources indicate that a representative’s refusal to participate does not halt the inspection. This single rule reshapes staffing policy. A site where inspectors arrive and no trained person is present will be inspected anyway, with results recorded unilaterally. Cross-training several employees per site, and posting the inspection response card at each duty station, are the two cheapest controls against that scenario, and they cost far less than contesting a one-sided inspection record afterwards.

4. Practical recommendations

1. Prepare a one-page inspection response card stating: request the legal basis of the inspection, record what is announced, designate an accompanying person, and keep a handover list for every document provided.
2. Train night-shift and weekend duty staff in document retrieval, covering both electronic and physical forms, and refresh the training at least annually.
3. Do not give unverified oral explanations on site; submit all explanations in writing within 3 working days as a practical estimate.
4. Complete an internal report within 24 hours after the inspection ends, assessing whether change notifications or vigilance obligations have been triggered.
5. Log every inspection, including refused or aborted visits, in a central register so that patterns across sites and years become visible to management.

5. Verification checklist

• □ Inspection response card prepared and distributed to duty posts
• □ Night-shift and weekend staff trained in document retrieval
• □ Dual-form retrieval capability, electronic and physical, verified
• □ On-site notification record template ready
• □ 24-hour post-inspection internal reporting mechanism established
• □ Central inspection log maintained across sites

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.