Georgia Medical Device ISO 13485 Evidence: QMS Certification and Companion Materials

1. Key takeaways

An ISO 13485 certificate can be submitted in Georgia as quality management system evidence. The legal support is the Product Safety and Free Movement Code, Law No. 6157-Iს of 8 May 2012, Article 2(1)(f), which provides that certification and conformity assessment are carried out under international and European systems. The certificate, however, is only one piece of evidence. It needs to be submitted together with three companion materials: a statement of the scope of production covered by the certificate, confirmation of the certificate’s validity period, and documentation of the certification body’s accreditation status.

The reason for the companion materials is straightforward. Article 2(1)(f) establishes a system-recognition principle, not an automatic-validity principle. A certificate issued under an internationally recognised system is acceptable in principle, but its acceptability depends on the certificate itself being valid under that international system. The accreditation status of the issuing body is therefore a substantive point of review, not a formality.

A further and frequently missed point is that Georgian law extends its statutory procedures beyond design and production. Article 66 of the Health Care Law of Georgia covers maintenance and repair as well, and a QMS evidence package that stops at the manufacturing stage leaves a visible gap against that obligation. Finally, under Government Decree No. 278 of 1 August 2023, the authority can conduct on-site inspections, so QMS evidence must match what inspectors will actually find on the ground.

The three companion materials serve different review functions. The statement of production scope tells the reviewer that the certificate covers the category of the product being registered, because certificates often name sites and product families in annexes rather than on the face page. The validity confirmation tells the reviewer that the evidence is current, and a certificate close to expiry invites a question about what happens after it lapses. The accreditation statement tells the reviewer that the issuing body is recognised under the international system on which Article 2(1)(f) relies. Manufacturers can pre-empt these review points by requesting a scope letter and an accreditation extract from the certification body at the same time as the certificate itself; most accredited bodies issue such documents routinely, and presenting them unprompted removes a question before it is asked.

There is also a timing dimension. Registration is not completed in a week, and the certificate must remain valid while the file is under review. A certificate that expires during review does not automatically invalidate the dossier, but it generates correspondence, and correspondence is delay. Planning the renewal calendar of the certificate against the expected review timeline is therefore part of dossier strategy, not certificate housekeeping.

2. Legal basis

1. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს of 8 May 2012: Article 2(1)(f) (conformity assessment carried out under international and European systems).
2. Article 2(1)(g): advancement of quality infrastructure and market surveillance systems.
3. Article 2(3): products manufactured in conformity with the EU New Approach and Global Approach directives are deemed to satisfy the essential safety requirements.
4. Health Care Law of Georgia, Law No. 6000 of 21 March 2008, Article 66: design, production, maintenance and repair are carried out according to procedures established by law.
5. Government Decree No. 278 of 1 August 2023 of Georgia: the authority may conduct on-site inspections.

3. Expert insights

Insight one: Article 2(1)(f) establishes system recognition, not automatic validity of certificates.

The provision requires that conformity assessment in Georgia be conducted under international and European systems. This creates the acceptance basis for internationally recognised ISO 13485 certificates. The precondition, however, is that the certificate itself is valid under the international system, which places the accreditation status of the certification body at the centre of the substantive review. A certificate from a body without recognised accreditation, or a certificate whose scope does not cover the product category being registered, can be discounted regardless of how reputable the standard is.

Insight two: Article 66 brings maintenance and repair into the statutory scope, and QMS evidence must cover that stretch.

Most manufacturers hold ISO 13485 certificates whose scope ends at design and production. Georgian law, by contrast, lists maintenance and repair among the activities that must follow legally established procedures. The gap between the certificate scope and the statutory obligation needs to be closed with dedicated service work instructions and record-keeping procedures, submitted as supplementary QMS documentation. Without them, the evidence package answers a narrower question than the law asks.

The supplement need not reorganise the QMS. A maintenance and repair procedure, a set of service record templates and a training plan for service personnel are usually sufficient to show the obligation is implemented, and they can be annexed to the dossier separately from the certificate, clearly marked as supplementary QMS evidence.

Insight three: Government Decree No. 278 of 1 August 2023 means QMS evidence can be verified on site at any time.

The decree allows the authority to conduct inspections, and inspections include the retrieval and copying of documents. A QMS cannot exist only inside the dossier. The consistency between the company’s actual operational records and the documents submitted in the registration file directly affects inspection outcomes, and mismatches discovered on site are far more damaging than deficiencies found during desk review because they call the entire dossier into question.

4. Practical recommendations

1. When submitting the ISO 13485 certificate, attach a statement of the certification body’s accreditation status together with the certificate scope page, confirming that the registered product category is covered.
2. Supplement maintenance and repair procedure documents, so that the statutory obligation of Article 66 of the Health Care Law is implemented inside the QMS.
3. Check the certificate validity period; if the remaining validity is less than 12 months, renew the certificate first and file the application afterwards.
4. Run a dossier-versus-premises consistency self-check, ensuring that records matching the submitted documents can be retrieved immediately during an inspection.

5. Verification checklist

• □ The ISO 13485 certificate is within its validity period and covers the registered category
• □ A statement of the certification body’s accreditation status has been attached
• □ Maintenance and repair procedure documents have been supplemented
• □ The certificate’s remaining validity has been checked, with renewal first if less than 12 months remain
• □ The dossier-versus-premises consistency self-check has been completed

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 ISO 13485 evidence packaging and accreditation statements to inspection-ready QMS records. For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.