Uzbekistan Sample Submission Rules and Exemptions for Device Registration

1. Key takeaways

Under Resolution No. 738, sample submission follows a structure of principle plus exemption: the applicant must provide a sufficient quantity of samples for testing as required by the normative documents, but the recognition pathway and ordinary Class I devices are usually exempt from submitting samples, and the Class I exemption does not extend to sterile, measuring, and invasive Class I devices. In addition, reference standards, control materials, dedicated reagents, test strains, diagnostic systems, and manufacturer-specific consumables must be submitted together with the samples where needed, and these items are exempted under the recognition pathway. The practical consequence is that sample obligations must be assessed twice, once for the pathway and once for the risk class, before any logistics or budget decision is made.

In budgeting terms, the exemption structure rewards the same front-loaded analysis as the evidence structure: a short written determination of pathway, class, and the three exceptions, agreed before shipment, prevents both unnecessary freight costs for samples that were never required and emergency shipments for samples that were. The determination should be attached to the project file, because it documents why samples were or were not sent and supports the declaration at import.

2. Legal basis

3. Expert insights

Insight one: the sample exemption is the sum of a pathway dividend and a class dividend. The sample exemption of the recognition pathway stems from evidence already generated abroad, while the exemption for ordinary Class I devices stems from a risk level low enough not to require local testing. The two dividends can be combined, but both are pierced by the three exceptions of sterile, measuring, and invasive devices. When estimating sample costs, manufacturers should first determine whether the three exceptions apply and only then look at the pathway.

Insight two: the complexity of sample submission lies in logistics, not in quantity. Samples must be delivered directly to the center under controlled storage and transport conditions. Cold-chain products need temperature records for the entire journey, active devices with lithium batteries must comply with transport rules, and large equipment may need to be installed and inspected on site. All of this is far more complex than shipping a few machines, which is why the sample stage should be placed on the critical path alongside the authentication chain.

Insight three: the sample requirements for diagnostic systems and dedicated consumables are often missed. The review of in vitro diagnostic devices requires diagnostic systems, dedicated reagents, and manufacturer-specific consumables to work together. Submitting reagents without the paired instruments, or instruments without the consumables, makes testing impossible. The sample list of an IVD project should therefore be prepared as a single package of system, reagents, and consumables.

Insight four: the exemption for import for registration procedures resolves the legality of bringing samples into the country. Resolution No. 738 lists import for the purpose of the national registration procedure among the situations that do not require registration. This arrangement works together with the sample submission rules: a company can lawfully ship samples into Uzbekistan for testing without first holding a registration certificate. The quantity, however, should match the actual needs of testing.

4. Practical recommendations

1. Apply a three-step sample exemption test: first the pathway (recognition or general), then the class (I, IIa, IIb, or III), and finally the three exceptions (sterile, measuring, invasive).
2. For IVD projects, prepare the sample list as one package covering the system, the reagents, and the consumables.
3. Confirm transport arrangements for cold-chain and battery-powered products with the authorized representative in advance, and retain temperature-control and transport compliance records.
4. Declare sample import under the import for registration procedures provision, keep the quantity consistent with testing needs, and retain the records.
5. Confirm the availability of reference standards and control materials early, since the procurement lead time for these materials is often longer than for the device itself.

5. Verification checklist

• □ The three-step sample exemption test is complete across pathway, class, and the three exceptions
• □ The sample list covers the system, the reagents, and the consumables (for IVD projects)
• □ The controlled storage and transport conditions are confirmed with the authorized representative and records are retained
• □ Sample import is declared under the import for registration procedures provision, with quantity consistent with testing needs
• □ The availability of reference standards, control materials, and dedicated reagents is confirmed in advance
• □ Recognition-pathway cases confirm that reference standards and control materials are exempted together

GRZAN provides registration support in Uzbekistan for manufacturers, importers, and authorized representatives, including sample exemption analysis and logistics planning. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.