Kyrgyzstan IVD Performance Evidence: Clinical Laboratory Testing under Decision No. 29

1. Key takeaways

In Kyrgyzstan, in vitro diagnostic devices have an independent legal definition, placed alongside therapeutic devices rather than subordinate to them. Their evidence framework runs along two lines: analytical performance and clinical performance. Analytical performance is demonstrated through technical testing (Decision No. 28) and clinical laboratory trials (Decision No. 29); clinical performance is demonstrated mainly through clinical laboratory trials. An IVD system is constituted jointly by the instrument, reagents, calibrators, controls and dedicated software, and registering only the instrument while omitting the reagents and software is not an option. Planning the dossier around the system rather than the box is the single most important structural decision for IVD manufacturers entering Kyrgyzstan.

2. Legal basis

1. Law No. 216, Article 3: an independent definition of in vitro diagnostic medical devices, covering instruments, apparatus, equipment, materials, reagents, calibrators, control materials and other products, including dedicated software, and information concerning physiological or pathological states, congenital abnormalities, susceptibility or tissue compatibility.
2. Resolution No. 513 of the Cabinet of Ministers, dated August 27, 2024, paragraph 4 of Article 2: technical testing follows Council Decision No. 28 dated February 12, 2016.
3. Resolution No. 513, paragraph 5 of Article 2: clinical and clinical laboratory trials follow Council Decision No. 29 dated February 12, 2016.
4. Resolution No. 513, paragraph 1 of Article 2: classification follows Board Decision No. 173 dated December 22, 2015; both devices and IVDs are divided into the four classes 1, 2a, 2b and 3.
5. Resolution No. 513, paragraph 3 of Article 2: biological effect evaluation follows Council Decision No. 38 dated May 16, 2016.

3. Expert insights

Insight 1: The IVD definition in Law No. 216 is broader than the usual understanding.

The definition covers five layers: instruments, apparatus, equipment and materials; reagents; calibrators; control materials; and dedicated software and related information. These five layers form a single whole. When preparing an IVD registration dossier, companies should organize it around the system rather than the standalone unit: instrument plus reagents plus calibrators plus controls plus software, with no element missing. A dossier that names a system but documents only the analyzer invites deficiency letters asking for the missing components.

Insight 2: Clinical laboratory trials in the title of Decision No. 29 are the main evidence channel for IVDs.

The full title of Decision No. 29 concerns the rules for conducting clinical and clinical laboratory trials (studies) of medical devices. Clinical laboratory trials correspond to performance verification on samples under laboratory conditions, which is precisely the main route by which an IVD demonstrates both analytical and clinical performance. IVD companies should explicitly follow this channel rather than importing the clinical trial framework designed for therapeutic devices. Naming the correct channel in the evidence plan signals regulatory literacy and shortens the reviewer’s path through the file.

Insight 3: IVDs are also classified into classes 1, 2a, 2b and 3, with criteria including effects on vital organs.

The classification criteria under Decision No. 173 include the intended purpose and conditions of use, duration of use, invasiveness, the manner of contact with the human body, and whether the device acts on vital organs. For IVDs, the clinical significance of the analyte or test (for example, whether the test is used to screen for major diseases, or for blood grouping and tissue matching) materially affects the class determination. We recommend comparing the criteria item by item in the classification rationale rather than assigning classes by product category at a glance.

Insight 4: The value of the simplified pathway for IVDs lies in the waived clinical trial reports.

The simplified pathway can waive clinical trial reports and efficacy and safety test protocols. For IVDs, these two documents are typically the thickest and slowest-preparing parts of the evidence package. IVD companies holding approvals from the eight reference jurisdictions gain an even greater time advantage than therapeutic device manufacturers. Evaluating eligibility for the simplified pathway early in the project can reshape the entire evidence budget.

Insight 5: The combination of reagents and instruments determines dossier capacity planning.

Under the type-model structure of article 23 of this series, IVD systems are usually organized as one type containing multiple models. Differences in reagent presentation (packaging size, reaction volume) generally constitute model-level differences that can sit within one dossier; but a new analyte (for example, extending from antibody A to antibody B) may constitute a different intended purpose and requires a separate assessment of whether it belongs to the same type. Drawing this line clearly in the dossier plan prevents both under-inclusive filings and unnecessary duplicate registrations.

4. Practical recommendations

First, organize the IVD dossier as a system and list every component. Open the dossier with a system composition table: instrument models, reagent list, calibrators, control materials, and software names and versions, with the registration status of each component noted.

Second, explicitly select the clinical laboratory trial channel. State the trial category in the evidence plan and prepare separate protocols and reports for analytical performance and for clinical performance.

Third, compare the Decision No. 173 criteria item by item in the classification rationale. Highlight the criterion on effects on vital organs, and explain the clinical significance of the analytes covered by the submission.

Fourth, manage specifications and analytes separately. Include different presentations of the same analyte in the model list of one dossier; treat a new analyte as a distinct intended purpose, assessed on its own and filed separately where necessary.

Fifth, prepare transport and storage evidence for reagents. Assemble shipping stability and storage stability data: these serve the dossier requirements and also affect compliance at the import stage (see article 37 of this series).

5. Verification checklist

• □ The IVD dossier is organized as a system, with a composition table covering instrument, reagents, calibrators, control materials and software;
• □ The evidence plan explicitly selects the clinical laboratory trial channel (Decision No. 29), with separate preparation for analytical and clinical performance;
• □ The classification rationale compares the Decision No. 173 criteria item by item, with particular explanation of effects on vital organs;
• □ A distinction is drawn between different presentations of the same analyte (included in the model list) and new analytes (assessed separately);
• □ Transport stability and storage stability data prepared;
• □ Where approvals from the eight reference jurisdictions are held, the scope of waived clinical trial reports under the simplified pathway has been assessed.

Regulatory information verified as of October 29, 2026.

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The GRZAN regulatory team consists of professionals with many years of hands-on experience in Eurasian Economic Union registration. We maintain a stable local cooperation network in Bishkek, Almaty, Tashkent and Moscow, work in Chinese, Russian and English, and provide executable solutions for foreign manufacturers on the issues most commonly encountered in CIS markets: authorized representative arrangements, notarization and legalization chains for powers of attorney, technical documentation localization, and inspection readiness. GRZAN supports manufacturers, importers and authorized representatives throughout the Kyrgyzstan registration lifecycle.

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