Georgia Medical Device Public Procurement: Registration Status as a Bid Threshold

1. Key takeaways

In Georgian public procurement and tender scenarios, the registration status of a medical device is a hard threshold: the bidder must prove that the product has completed registration under Article 11⁴ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009, and is entered in the departmental register under Article 11⁶. The evidence strategy should rely on the register record as the primary proof and the registration certificate as secondary, and neither substitutes for the other. The register is maintained by the institution and is publicly searchable, so the contracting authority can verify it directly, while a paper certificate must be authenticated. Beyond the threshold, tender scenarios carry two further regulatory hooks: Article 67 paragraph 1 of the Law on Health Care No. 6000 of March 21, 2008 allows ministries to set quality and safety standards for medical technology devices, which can become scored technical requirements, and Article 11¹⁰ paragraph 6 of Law No. 1586 allows revocation and removal from the register, which converts any post-market compliance failure into a bid capability loss. The practical consequence is that tender readiness and regulatory maintenance are one program: the same register record that opens the bid door must stay clean to keep it open. as a practical estimate. Bidders should therefore read every tender document as a standalone specification and never copy evidence formats from a previous tender without checking.

2. Legal basis

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11⁴ (the two registration procedures), Article 11⁶ (the departmental register), Article 11⁵ (period of validity), Article 11¹⁰ paragraph 6 (revocation and removal from the register).
2. Article 1¹: the definition of an interested person and the definition of the departmental register.
3. Law of Georgia No. 6157-Iს of May 8, 2012 on product safety and free movement, Article 3 paragraph 1 and Article 3 paragraph 2.
4. Law of Georgia on Health Care No. 6000 of March 21, 2008: Article 66, Article 67 paragraph 1 and Article 67 paragraph 2.
5. Practical estimate statement: the concrete evidence formats and scoring approaches of tender documents are stated in no official legal provision and follow the requirements of each tender.

3. Expert insights

Insight one: the register is the credential a contracting authority can verify most easily. The departmental register established under Article 11⁶ is maintained by the institution and open to inspection, so a tender evaluator can confirm registration status directly and without authentication effort. A paper certificate, by contrast, must have its authenticity established. The evidence strategy follows from this asymmetry: lead with the register search record, dated and archived, and present the certificate as corroboration. Bidders who reverse this order create avoidable friction, because evaluators then spend verification effort on a document that the register would have confirmed in one query. Keeping a standing register search in the bid library, refreshed on a schedule, turns the threshold item into a five-minute download. The search date on the record matters, because it fixes the moment at which the status was true, and an evaluator can reconcile it with the bid submission date.

Insight two: Article 67 paragraph 1 can make conformity with standards a scored technical item. Ministries are empowered to set quality and safety standards for medical technology devices. Where tender technical specifications cite such standards, bidders must respond item by item, and although the number of publicly available dedicated standards is currently limited, any published standard that goes unanswered can eliminate the bid directly. Procurement teams should therefore monitor the standard-setting activity tied to Article 67 as part of tender readiness, maintain a response matrix mapping each product to the standards it meets, and attach the standard numbers and evidence page indexes to every bid rather than assembling them at submission time. Where a cited standard is not met, the response should say so explicitly and state the mitigation, because silence is scored as non-response.

Insight three: the revocation risk of Article 11¹⁰ paragraph 6 is amplified in procurement scenarios. Revocation removes the product from the register, which fails not only the current bid but can render awarded projects unperformable, triggering default and contractual liability. Post-market compliance and bid capability are two faces of the same asset: vigilance reporting, change filings and periodic updates protect the register entry, and the register entry protects the revenue stream that tenders provide. Finance and sales leadership should therefore read a post-market compliance budget not as a regulatory overhead but as insurance on the tender pipeline, since one revocation can outweigh years of saved compliance effort. The same logic applies to change filings: an unfiled change that surfaces during contract performance looks like bad faith to the contracting authority, not just a procedural lapse.

4. Practical recommendations

1. Maintain a standing bid document package: the register search record including the search date, a scan of the registration certificate, a statement of the period of validity, and a sample of the Georgian-language labeling.
2. Re-verify the register status and the validity period 7 working days before bidding, and start the renewal procedure first for registrations close to expiry.
3. Respond to every technical specification item by item, attaching the standard numbers and an evidence page index for each response.
4. Include post-market compliance, covering vigilance, change filings and periodic reports, in the bid qualification maintenance list, so that no compliance lapse endangers the tender pipeline.

5. Verification checklist

• □ The four elements of the bid document package are complete
• □ The register status and validity period were re-verified before bidding
• □ Technical specifications have been answered item by item with an evidence index
• □ The Georgian-language labeling sample is ready
• □ Post-market compliance is included in the bid qualification maintenance list

Regulatory information verified as of October 30, 2026

This English edition of the GRZAN international regulatory guide is published by GRZAN for informational purposes only. GRZAN supports manufacturers, importers and distributors with regulatory strategy, registration filings, local representative coordination, labeling review and import compliance for Georgia and other markets. For questions about this article or tailored regulatory support, contact info@grzanglobal.com.