Georgia Dental Materials Registration: Drug-Pathway Rules and Timelines

1. Key takeaways

Dental materials in Georgia belong to the categories subject to mandatory registration and are managed along the drug pathway, under the two registration regimes established by Article 11⁴ 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 timeline, the national regime takes approximately 2 months, the recognition regime approximately 15 days to 1 month, and the registration certificate is valid for 5 years. These three figures shape the entire project economics of a dental portfolio in Georgia and should be treated as planning values to be confirmed with the authority, not as legal entitlements.

The strategic takeaway is that dental materials are among the few categories where the recognition regime can be used reliably. Mainstream dental materials hold CE certificates in the European Union, so sameness evidence is complete by default. For such products, recognition should be the default route, and the national regime should be reserved for cases where the evidence chain is broken — for example, where the manufacturing site has changed and the comparison can no longer be closed cleanly.

The portfolio consequence is that a dental line should be mapped by material family before any filing decision is made. Filling materials, impression materials, bonding agents, and denture materials differ in the evidence they require — composition and curing behaviour for one group, mechanical performance for another — but they share the drug-pathway characterisation and the sameness logic of the recognition regime. A single mapping exercise across the whole line, done before the first filing, prevents the common failure of discovering mid-project that one model family lacks CE coverage and must be diverted to the national regime with its longer timeline.

2. Legal basis

The following provisions and materials define the treatment of dental materials.

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 (sectoral registry).
2. Article 1¹ definition of medical supplies: the provision expressly lists prosthetic and orthopaedic products among medical supplies, providing the definitional entry point through which dental materials fall within the scope of the law.
3. 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 new approach and global approach directives of the European Union satisfy the essential safety requirements of the code.
4. Law of Georgia on Health Care, Law No. 6000 of March 21, 2008, Article 67 paragraph 2: type approval of measuring instruments.
5. Practical estimate statement: the inclusion of dental materials in the mandatory registration categories, the approximately 2-month and 15-day timelines, and the 5-year certificate validity are not stated in any official legal text and derive from established industry practice.

Taken together, the provisions explain the apparent paradox of dental materials in Georgia: a product class that most markets treat as a device is registered here under a pharmaceutical statute, because the definitional gateway of Article 1¹ admits prosthetic and orthopaedic products, and dental materials enter through that gateway rather than through any device-specific rule.

3. Expert insights

Insight 1: dental materials enter the drug law through the prosthetic and orthopaedic listing in the medical supplies definition. Article 1¹ names prostheses and orthopaedic products as examples of medical supplies, and dental materials — filling, impression, bonding, and denture materials — enter the scope of the law through that listing. This characterisation determines the architecture of the registration file: it resembles a pharmaceutical dossier rather than a device file organised by risk class. Teams that prepare dental dossiers in the structure of an EU technical documentation set will find that the Georgian review expects composition, biocompatibility, and performance evidence arranged in the pharmaceutical manner.

Insight 2: dental materials are one of the few categories where the recognition regime can be used stably. Mainstream dental materials hold CE certificates in the European Union, so the same-product evidence required by Article 11⁷ is complete and current. For these products, recognition should be treated as the default option, with the national regime used only when the evidence chain breaks — a site change, an acquired certificate, or a model family that was never covered by the reference approval.

Insight 3: dental devices with measuring functions trigger a second layer of obligation. Products with measuring capability, such as dental calipers and measuring probes, are subject to type approval under Article 67 paragraph 2 of the Health Care law in addition to registration. Portfolio mapping should therefore include a dedicated field recording whether a product has a measuring function, because this attribute, not the product name, determines whether a second approval track must be opened and budgeted.

4. Practical recommendations

The following practices align a dental portfolio with the Georgian pathway realities.

1. File dental materials by default under the recognition regime, with the dossier built around the CE certificate plus the sameness comparison table as its two central exhibits.
2. For material products, focus the technical file on composition, biocompatibility, and curing and mechanical performance evidence — a different emphasis from equipment products, where electrical safety and software dominate.
3. Group the product line by material and model family when filing, rather than applying SKU by SKU, which otherwise drives the number of submissions and their cost out of proportion to the market size.
4. For devices with measuring functions, start the type-approval assessment separately and run it in parallel with registration, so the second track never becomes the bottleneck of the launch plan.
5. Keep the reference-country certificates under active renewal management, because the recognition route for dental materials depends entirely on the continuity of the European approvals behind the sameness comparison.

5. Verification checklist

• □ Confirmed the product falls within the medical supplies definition and requires mandatory registration
• □ CE certificates cover all filed model families
• □ Sameness comparison table completed
• □ Biocompatibility and performance evidence assembled
• □ Type-approval assessment started for devices with measuring functions

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.