Georgia IVD Registration: Nosology-Based Categories and 5-Year Certificates

1. Key takeaways

In vitro diagnostic products in Georgia are registered along the drug pathway, under Article 11⁴ and Article 11⁷ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009. According to established industry practice, which is a practical estimate rather than a statutory enumeration, the categories subject to registration include test systems organised by disease entity, allergens except individualised allergens, clinical biochemistry and clinical chemistry reagents, and sera. The registration certificate is valid for 5 years. The nosology-based organisation of the categories is the feature that most distinguishes Georgian IVD registration from device-style systems and drives how a portfolio must be counted and filed.

Two planning consequences follow. First, because test systems are registered by disease entity rather than by platform, the counting unit for a Georgian IVD project is the disease indication, not the instrument or the reagent kit. Second, because Article 11³ paragraph 6 prohibits unregistered products from claiming disease treatment, the marketing calendar must be locked to the registration calendar; launching claims before the certificate exists creates direct exposure under that provision.

The 5-year validity of the certificate gives the nosology-based structure a long planning horizon, but it also means that a growing assay menu accumulates filings at a steady rate. A laboratory that adds several disease indications per year is running a permanent registration programme, not a one-off market entry. Treating IVD registration as a continuous workstream — with a standing product matrix, a standing evidence library, and a standing compliance gate for promotional material — is the only operating model that fits the Georgian category structure.

2. Legal basis

The following provisions define the IVD registration route.

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11⁴ (the two regimes), Article 11⁷ (recognition regime), Article 11¹¹ (national regime), Article 11⁵ (validity), Article 11⁶ (registry).
2. Article 1¹ definition of radiopharmaceutical and diagnostic medical products: products with ionising radiation properties and/or chemical products used in medical practice.
3. Article 11³ (Article 113) paragraph 6: products not registered as drugs and not voluntarily registered under the national regime may not claim disease treatment.
4. Law of Georgia No. 6157-Iს on Product Safety and Free Movement of May 8, 2012, Article 2 paragraph 3: products manufactured in conformity with the European Union approach directives satisfy the essential safety requirements of the code.
5. Practical estimate statement: the list of IVD categories subject to registration, the nosology-based management approach, and the 5-year validity are not stated in any official legal text and derive from established industry practice.

Read together, the provisions place IVDs squarely inside the pharmaceutical framework while leaving the concrete category list and its granularity to practice. That combination — a firm statutory route with a practice-defined scope — is why the practical estimate statement appears explicitly in the legal basis and why category confirmation with the authority should precede any filing.

3. Expert insights

Insight 1: Georgia treats IVDs as diagnostic medical products, which is a chemistry logic rather than a device logic. The Article 1¹ definition of diagnostic medical products settles on chemical products used in medical practice, showing that the Georgian characterisation gives chemical substance attributes priority over instrument attributes. This decides where the weight of the registration file falls: on composition, stability, and analytical performance, rather than on the electrical safety and software lifecycle documentation that dominates device files. Teams reusing a device-style table of contents for an IVD submission will have to rebuild it before review.

Insight 2: nosology-based management is the distinctive granularity of IVD registration in Georgia. Industry practice indicates that test systems are registered by disease entity, not by platform and not by reagent. The same analytical platform running different clinical assays may therefore require separate filings for each disease indication. Portfolio planning must adopt the disease entity as the counting unit: the number of Georgian registrations is computed from the assay menu, and platform commonality reduces development cost but not the number of filings.

Insight 3: Article 11³ paragraph 6 imposes a real constraint on IVD promotion. The provision prohibits unregistered products from claiming disease treatment. IVD marketing materials routinely contain disease-association statements, and publishing such content before registration is granted carries direct violation risk. The compliance review of promotional material must therefore be scheduled before any market-facing release, and the marketing department timeline must be aligned with the registration timeline rather than the commercial launch plan. Claims language should be reviewed in the same cycle as label artwork, so that no approved asset reaches a distributor or a website carrying a prohibited statement.

4. Practical recommendations

The following practices keep an IVD portfolio and its promotion inside the legal perimeter.

1. Build a product matrix across disease entities and platforms, defining every filing unit explicitly, so that no indication is missed and no unit is filed twice. The matrix should be the single source of truth for the registration project plan.
2. Prepare analytical performance documentation — precision, accuracy, detection limit, interference — separately for each filing unit rather than sharing one report across the menu, since the review evaluates each unit on its own data.
3. Cover stability evidence across transport and storage conditions, and reflect Georgian cold-chain conditions in the stability protocol so the data match the distribution reality the product will face.
4. Subject all marketing materials to compliance review before registration is granted, screening for disease-treatment claims that would engage the risk under Article 11³ paragraph 6.
5. Reconcile the product matrix with the certificate inventory after each approval, so the number of registered disease indications always matches what the sales organisation assumes it can promote.

5. Verification checklist

• □ All filing units defined across disease entities and platforms
• □ Analytical performance documentation prepared per filing unit
• □ Stability evidence covers local transport and storage conditions
• □ Marketing materials cleared against Article 11³
• □ CE or equivalent evidence covers all filing units

Regulatory information verified as of October 30, 2026

This English version was prepared by GRZAN for the international medical device registration guide. GRZAN provides regulatory translation, dossier preparation and market-entry support for Georgia and other jurisdictions. Questions about this article may be sent to info@grzanglobal.com.