Uzbekistan IVD Registration: Evidence Requirements and Emergency Review Track

1. Key takeaways

In vitro diagnostic devices (IVDs) are registered in Uzbekistan as medical devices, but they are subject to a separate evidence standard: in addition to the general technical documentation, an IVD application must include an analytical performance and sensitivity testing report, proof of the absence of infectious agents in IVDs prepared from biological material, and storage and transport stability information. In addition, Resolution No. 738 establishes for IVDs intended for specific epidemic or pandemic use a review track of 30 working days with a registration validity of 1 year. Whether an IVD dossier is complete is judged by whether these three dedicated evidence sets are present. The distinction matters commercially as well: the short review and the short validity of the emergency track signal that it is reserved for public health response, so ordinary commercial products must be planned against the ordinary class timelines and the ordinary 5-year term. Foreign IVD manufacturers carry one additional documentary obligation that domestic producers do not: the normative documents of their home country must be submitted, which means the dossier cannot simply copy a local template. Software-based IVDs sit at the intersection of two exemption lists, and each item must be read against its own wording rather than by analogy between the software and IVD exclusions.

2. Legal basis

3. Expert insights

Insight one: the testing of an IVD has two layers, and companies often submit only one. The dedicated and sensitivity testing report required by item 2.11 addresses analytical performance (limit of detection, linearity, precision, interference, cross-reactivity and similar parameters), while the proof required by item 2.12 addresses the biosafety of biological material. Most first-time IVD dossiers cover only the first layer, and the second is supplemented during the deficiency response, which directly pushes the project schedule. Building both layers into the dossier before submission is the cheapest way to protect the review clock.

Insight two: the requirements for normative documents differ between foreign and domestic products. Item 2.6 distinguishes the normative documents of foreign IVDs from those of domestic IVDs (drafts). A foreign manufacturer must provide the normative documents of its own country, while a domestic producer submits a draft. This difference means a foreign manufacturer cannot simply reuse the document template of a local partner, and the home-country standards referenced must correspond to the product actually submitted.

Insight three: the 30 working day track is an emergency design, not an ordinary fast lane. The track for IVDs intended for epidemic or pandemic use carries a review period of 30 working days and a registration validity of 1 year; the short validity itself shows that this is a channel designed for emergency response. Ordinary commercial IVD projects should still be scheduled against the ordinary class periods (60, 90, 120 and 120 working days) and the 5-year validity, and teams that benchmark commercial timelines against the emergency track systematically under-plan their launch dates.

Insight four: the exemption lists for software-based IVDs and stand-alone software differ, and they must not be cross-referenced. In the registration dossier format, certain items are expressly not applicable to software, and other items are expressly not applicable to IVDs. Whether a given item is waived depends on the specific wording of the item about the excluded object, not on an experience-based assumption that software or IVD status exempts everything. Reading the two lists against each other produces dossiers that answer questions never asked and omit questions that were.

4. Practical recommendations

1. Build an IVD-specific evidence list with separate columns for analytical performance, biological material safety and stability, confirming the source report of each item.
2. For foreign IVDs, prepare the normative documents of the home country early and do not reuse the templates of local partners.
3. Schedule ordinary commercial projects against the ordinary periods and the 5-year validity, not against the 30 working day emergency track.
4. Check the exemption items for software and IVD status item by item against their own wording, without cross-referencing.
5. Keep stability data consistent with the shelf life marking, with expiry labels of supplied batches following the conclusions of the stability study.

5. Verification checklist

• □ The analytical performance and sensitivity testing report is complete (limit of detection, linearity, precision, interference, cross-reactivity)
• □ IVDs prepared from biological material have submitted proof of the absence of infectious agents
• □ Storage and transport stability information has been submitted and is consistent with the shelf life marking
• □ The foreign IVD has submitted the normative documents of its home country
• □ Ordinary projects are scheduled against 60, 90, 120 and 120 working days with a 5-year validity, without misuse of the emergency track
• □ The exemption items for software and IVD status have been checked item by item

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with IVD registration and evidence planning, contact info@grzanglobal.com.