Georgia Health Care Law Chapter VIII 2026: Medical Technical Devices Lifecycle Obligations

1. Key takeaways

The origin provisions of Georgian medical device regulation are Article 66 and Article 67 of Chapter VIII of the Law of Georgia on Health Care, Law No. 6000 (21 March 2008): in total 2 articles and 3 paragraphs, which provide that the full device lifecycle proceeds according to procedures established by legislation, that the ministry develops quality and safety standards, and that measuring instruments require type approval and registration. Article 66 covers the entire chain of design, manufacture, maintenance and repair, a scope that is wider than most companies assume. Because the chapter is so compact, every word carries weight, and obligations that manufacturers in other markets habitually assign to voluntary service standards are here anchored directly in statute. For capital equipment such as imaging and radiotherapy systems, where service engineers remain on site for many years after installation, this statutory anchoring changes the compliance calculus well before any registration question is even raised, and it should be reflected in the local service agreements and quality system documentation from the outset of the project.

It is also worth reading the chapter as a whole rather than article by article. The deleted Article 65, the lifecycle rule of Article 66 and the standards and metrology rules of Article 67 together sketch a complete regulatory arc: the state claims the entire technical life of a device, delegates the substantive standards to the ministry, and reserves a special lane for measuring instruments. When a company assembles its compliance matrix, mapping each clause of the chapter against a named owner inside the organisation, the exercise typically takes less than a day and surfaces the same finding almost every time: the service organisation, not the regulatory affairs department, is the function least prepared for statutory obligations. Early allocation of the chapter duties across departments is therefore the highest-yield half-day available in the project plan.

2. Legal basis

1. Law of Georgia on Health Care, Law No. 6000, adopted on 21 March 2008, published as LHG I, No 9, 4.4.2008, Art. 75.
2. Chapter VIII on Medical Technical Devices and Medical Technology: Article 65 (deleted), Article 66 and Article 67.
3. Article 66: the design, manufacture, maintenance and repair of medical technical devices proceeds according to the procedures established by legislation.
4. Article 67(1): the ministry, together with the relevant state bodies, develops and implements quality and safety standards for medical technical devices and medical technology.
5. Article 67(2): the type of a measuring instrument must be approved in accordance with the law, entered in the registry, and imported and manufactured accordingly.

3. Expert insights

Insight 1: Article 66 writes maintenance and repair into statutory duty. Most registration consultancies discuss only market placement, but Article 66 brings maintenance and repair, in addition to design and manufacture, within the scope of activities that proceed according to legislatively established procedures. For categories that require long-term on-site service, such as imaging equipment and radiotherapy equipment, this means that the after-sales service stage carries compliance obligations of its own, and service records should be integrated into quality system documentation. A service visit that alters the configuration or performance of a device is not merely a commercial event; it is an activity expressly named in the statute, and the associated records are the evidence that the obligation was met. Companies that discover this only during an inspection typically lack the documentation trail that the provision implies, and retrofitting a service record system after years of operation is far more expensive than designing it correctly at launch.

Insight 2: Article 67(2) is a hidden threshold for devices with a measuring function. The paragraph provides that the type of a measuring instrument must be approved and entered in the registry before it can be imported and manufactured. Products with a measuring function, including blood pressure monitors, blood glucose meters, thermometers and infusion pumps, may trigger type approval in addition to registration, forming a second compliance line that is independent of registration. The two lines have different authorities, different documents and different timing, and the type approval line is the one most frequently missed in market entry plans, because it is buried in a paragraph that reads like metrology housekeeping rather than a device requirement. When assessing whether a product triggers the paragraph, the functional test is decisive: any device that displays, transmits or acts upon a measured physiological or physical quantity should be examined, regardless of how the product is marketed. The documentation burden of type approval is additive to the registration file, not duplicative of it, and the metrology authority and the registration authority follow separate calendars. Scheduling the two procedures in parallel, with the type approval started no later than the registration dossier, is the sequencing that experienced entrants adopt, because the measuring function is rarely the reason a product fails registration but frequently the reason a launch is delayed.

Insight 3: the deletion of Article 65 shows that the chapter has undergone substantive adjustment. Article 65, which originally stood in Chapter VIII, has been deleted, leaving a gap in the numbering sequence. This is a signal that companies citing the chapter should rely on the current consolidated version and should not carry forward article numbers from older versions. Citation hygiene matters in correspondence with the authorities: a letter that references a non-existent article number undermines the credibility of the entire submission and invites unnecessary clarification rounds, so the source text should be re-verified each time it is quoted in a formal document.

4. Practical recommendations

1. For products with a measuring function, start a type approval feasibility assessment at project initiation rather than after the registration application has been accepted.
2. Bring after-sales service, including maintenance and repair, within the compliance scope, and establish service work instructions and a record retention system.
3. Cite provisions from the current consolidated version on matsne and annotate the verification date in internal documents.
4. When signing agreements with local partners, specify explicitly which party bears the maintenance and repair obligations under Article 66.

5. Verification checklist

• □ Determined whether the product has a measuring function and triggers Article 67(2)
• □ Downloaded the current consolidated text of Chapter VIII of Law No. 6000
• □ Confirmed that the deleted status of Article 65 does not affect the article numbers cited
• □ Brought maintenance and repair within the scope of quality system documentation
• □ Specified the responsible party for maintenance and repair in the agreements

GRZAN international services — GRZAN supports manufacturers with lifecycle compliance analysis under the Health Care Law of Georgia, type approval feasibility assessment for measuring devices and service documentation design. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026