Kazakhstan Sample and Laboratory Study Requirements: Quantities, Shelf Life and Import Permissions

1. Key takeaways

Where laboratory studies are required, samples and reference samples must be provided in the quantities needed for three rounds of testing, with a remaining shelf life usually of at least six months, and must comply with the storage and transport conditions. Four categories of situations are exempt from laboratory studies: devices manufactured at production sites in the European Union, the United Kingdom, the United States, Canada, Japan or Switzerland and approved for circulation by the local regulator; re-registration; the accelerated procedure; and certain classes of medical equipment. Insufficient remaining shelf life is the most common cause of rework at the laboratory stage, and unlike most regulatory risks, it can be eliminated entirely before the samples ever leave the factory — it is purely a planning discipline issue, and the fix costs nothing but foresight in the production and shipping schedule.

2. Legal basis

3. Expert insights

Insight one: the quantity requirement of three rounds of testing is hard, yet it is routinely underestimated at the planning stage. Samples and reference samples must cover three complete rounds of testing, which directly affects the production plan and the shipping budget. For high-value equipment and customized devices, the sample cost can constitute a visible share of the project budget, and under-provisioning at this point means a second production batch, a second shipment and a second customs clearance, none of which appear in the original schedule. Counting the quantity requirement into the batch plan at the outset costs nothing; discovering it after dispatch costs a quarter.

Insight two: the six-month remaining shelf life requirement is a risk that can be avoided before shipment. The review verifies whether the remaining shelf life of the samples is sufficient for the study period. Samples consume time from production through shipping, customs clearance and warehousing, and if the remaining life is already close to the threshold at dispatch, the samples may expire while queued at the laboratory. The GRZAN practice is to move the shelf life requirement forward into the production planning stage, so that batches are allocated to registration projects while their dating is comfortably deep.

Insight three: the first exemption category matters as much as the others. The first category is a manufacturing site in the European Union, the United Kingdom, the United States, Canada, Japan or Switzerland combined with approval for circulation by the local regulator; in addition, re-registration and the accelerated procedure are likewise exempt. When planning iterations, companies should schedule new models as dossier changes within the re-registration frame rather than as fresh registrations, thereby reusing the existing study conclusions and skipping the laboratory campaign entirely.

Insight four: sample import runs on a dedicated channel. The import of samples of unregistered devices relies on the state service for issuing import and export permissions established by Order No. ҚР ДСМ-237/2020. Sample clearance and commercial clearance run on two separate document tracks, and mixing them is a reliable way to have samples detained at customs, which delays the laboratory start date by weeks and can push the project into a new quarter.

Insight five: market sampling is the second origin of samples. Order No. ҚР ДСМ-323/2020 governs the sampling of products in circulation. In the post-market phase, the regulator may draw samples from the market for retesting, which means the requirement for consistent sample quality continues to apply long after the certificate is issued, and the production process must be capable of reproducing the registered configuration on demand. Treating registration samples and market samples as one quality commitment, rather than two, is the cheapest way to stay ready for both.

4. Practical recommendations

1. Move the requirements of three rounds of testing and six months of remaining shelf life forward into the production planning stage.
2. Verify storage and transport conditions before shipment and retain the transport records.
3. Assess the four exemption categories first, especially the manufacturing site plus approval status and the re-registration routes.
4. Import samples through the dedicated permission channel of Order No. ҚР ДСМ-237/2020 and never mix documents with commercial clearance.
5. Plan iteration models as dossier changes wherever possible so that existing study conclusions are reused.

5. Verification checklist

• □ Samples and reference samples are prepared in the quantities required for three rounds of testing
• □ The remaining shelf life of the samples meets the requirement (at least six months recommended)
• □ Storage and transport conditions are met and transport records are retained
• □ All four exemption categories from laboratory studies have been assessed one by one
• □ Sample import has gone through the permission channel of Order No. ҚР ДСМ-237/2020
• □ Iteration models have been assessed for treatment as dossier changes

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering sample logistics, laboratory study coordination and expert review liaison. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.