Georgia Medical Device Type Approval: Measuring Instruments under the Health Care Law

1. Key takeaways

Medical devices with measuring functions trigger a second obligation in Georgia, on top of registration. Article 67(2) of the Health Care Law of Georgia, Law No. 6000 of 21 March 2008, provides that types of measuring instruments must be approved, entered in the register, imported and produced according to Georgian legislation. This is a compliance line independent of the registration system, and it is frequently overlooked.

The two lines are parallel and do not presuppose or substitute for each other. Type approval under Article 67(2) belongs to the Health Care Law of Georgia, while registration belongs to the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009. The legal sources differ and the regulatory logic differs. Obtaining the registration certificate does not complete type approval, and vice versa, so products with measuring functions must advance on both tracks at the same time.

A useful relief provision exists. Article 12(2) of Law No. 1586 of 10 August 2009 allows the manufacture of unregistered products for registration purposes. This resolves the legality of samples, so that companies can lawfully manufacture and submit samples even while neither type approval nor registration is complete. It is one of the few facilitative provisions in the Georgian framework and should be used deliberately, with written justification kept on file.

The scope of Article 67(2) should be read through the term measuring instrument. Devices that measure a physiological parameter, a delivered dose, a fluid volume or a physical quantity used for clinical decisions fall within the practical reading of the provision, even though no official guidance enumerates the covered products. The conservative approach treats any device whose output is a measurement relied upon for diagnosis or therapy as potentially within scope, and documents the analysis either way. Applicants should also budget administrative time for both tracks rather than assuming the registration authority coordinates the type approval file automatically.

2. Legal basis

1. Health Care Law of Georgia, Law No. 6000 of 21 March 2008, LHG I, No 9, 4.4.2008, Art. 75: Article 67(2), the type approval of measuring instruments, their entry in the register, and their import and production are carried out according to Georgian legislation.
2. Article 67(1): the ministry, together with the relevant state bodies, develops and implements quality and safety standards for medical technical devices and medical technologies.
3. Article 66: design, production, maintenance and repair are carried out according to procedures established by law.
4. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს of 8 May 2012, Article 3(2).
5. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009, Article 12(2): unregistered products may be manufactured for registration purposes, supporting sample submission.

3. Expert insights

Insight one: Article 67(2) is a rare product-level mandatory requirement in the Georgian legal sources for medical devices.

Most provisions of the relevant chapter of the Health Care Law are enabling or procedural, but this paragraph sets a direct pre-market requirement, approval and registration, on a specific category of products, measuring instruments. In an environment lacking a dedicated device law, Article 67(2) in practice performs part of the access-control function that device-specific legislation would otherwise carry. Companies whose products measure anything, from blood pressure to infusion volume to radiation dose, must check themselves against this provision rather than assume it applies only to metrology specialists.

The same paragraph also explains why type approval questions surface late in projects: they appear only when someone asks whether the measuring function is covered, which typically happens during dossier review or inspection rather than at project start. Recording the determination early, in writing and with the product specification attached, avoids that late surprise.

Insight two: type approval and registration are two parallel lines, with no mutual precondition and no mutual substitution.

Article 67(2) belongs to the Health Care Law of Georgia, while registration belongs to the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009. The two regimes have different legal sources and different regulatory logic. Holding a registration certificate does not mean type approval is done, and holding type approval does not mean registration is done. Products with measuring functions must run both tracks in parallel, with separate documentation lists, or one track will silently stall the other.

The two tracks also have different evidence bases. Registration evidence addresses the safety and performance of the device, while type approval addresses metrological conformity. Some documents, such as accuracy specifications and calibration procedures, serve both tracks, and identifying the shared documents early prevents duplicated preparation.

Insight three: Article 12(2) resolves the legality of samples.

The provision allows the manufacture of unregistered products for registration purposes. This means companies can lawfully manufacture and submit samples while both type approval and registration are still pending. It is one of the rare facilitative provisions in the Georgian framework, and it should be used fully, with a short written justification prepared for each sample batch stating that the purpose is registration and testing.

The boundary matters: Article 12(2) covers manufacture for registration purposes and does not authorise sale. Keeping samples out of commercial channels is therefore not only good practice but the edge of the permission itself, and consistent sample labelling is the visible proof that the boundary is respected.

4. Practical recommendations

1. Add a determining field for the presence of a measuring function at the project initiation stage, and start dual-track scheduling as soon as the field is triggered.
2. Advance type approval and registration in parallel, managing the documentation lists of the two tracks separately.
3. Prepare a written justification for sample production under Article 12(2) of Law No. 1586, stating that the purpose is registration and testing.
4. Keep sample labelling consistent with the final product, to avoid the samples being treated as actual sales during an inspection.

5. Verification checklist

• □ The measuring function determination has been completed and dual-track scheduling triggered
• □ The type approval and registration documentation lists are managed separately
• □ Sample production has been justified under Article 12(2) of Law No. 1586
• □ Sample labelling is consistent with the final product
• □ The source text of Article 67(2) has been archived

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Georgian market, from measuring function triage and dual-track scheduling to sample justification under Article 12(2). For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.