Uzbekistan IVD Registration: Performance Evidence and Normative Documents

1. Key takeaways

Beyond the general technical file, in vitro diagnostic devices must submit three dedicated evidence items: item 2.6 the normative document (foreign IVDs provide their existing normative document, while domestic IVDs provide a draft normative document), item 2.11 reports of dedicated and sensitivity testing (analytical performance), and item 2.12 proof of the absence of infectious agents in IVDs prepared from biological materials. In addition, items 2.19 and 2.20, covering color proofs of labeling and packaging and the instructions for use, are explicitly stated not to apply to software but do apply to IVDs. The practical effect is that an IVD dossier combines the general device evidence set with a distinct analytical layer, and the two layers must be consistent with each other before submission. Claims about detection capability written in the instructions for use must trace back to the analytical reports, so the drafting of the instructions and the planning of the analytical studies belong to the same workstream.

2. Legal basis

3. Expert insights

Insight 1: analytical performance is the technical core of an IVD, and the reports must cover the full parameter set. Item 2.11 requires reports of dedicated and sensitivity testing. For an IVD, this means coverage of the limit of detection, linear range, precision, interfering substances, cross-reactivity, and method comparison against a reference system. A comparison run on a single panel of samples cannot support a complete analytical performance argument, because reviewers look for evidence across the measurement range and across matrices, not at a single point. Planning the analytical study program so that each parameter has a defined protocol, sample set, and acceptance criterion before testing begins is the difference between one study campaign and several expensive repeats.

Insight 2: the distinction between foreign and domestic IVDs determines the source of the normative document. Item 2.6 explicitly separates foreign IVDs, which provide their existing normative document, from domestic IVDs, which provide a draft normative document. A foreign manufacturer should submit the normative document applicable in its country of origin, not draft a new document in a Uzbekistan local format, since drafting a local version is the obligation of domestic producers. The submitted document should also match the version referenced elsewhere in the dossier, because a normative document revision that postdates the test reports will raise questions about which version the evidence actually demonstrates.

Insight 3: biological material safety is a gate independent of analytical performance. The information required by item 2.12 on the absence of infectious agents concerns the safety of diagnostic reagents prepared from biological materials such as human blood derivatives. The requirement has nothing to do with analytical performance, yet it is the item most frequently missed, because it does not appear on any conventional performance validation checklist. Sourcing the manufacturing records of the biological raw materials, and any certificates attesting to screening of donations, belongs on the evidence list from the first project planning meeting.

Insight 4: the exemptions for IVDs and for software differ and must be checked separately. Items 2.19 and 2.20 do not apply to software but do apply to IVDs, while several other items, such as the sterility information in item 2.8, exclude software and in vitro diagnostic devices together. Judgment must rest on the exact wording of each item: only where the phrase software and in vitro diagnostic devices appears jointly are both categories exempt. Building the dossier plan from a literal reading of Annex 3a, item by item, prevents the double error of omitting a required IVD item or filing a document that the item does not request.

4. Practical recommendations

1. Build a dedicated IVD evidence list with three separate columns: the normative document, analytical performance, and biological material safety.
2. Cover the limit of detection, linear range, precision, interfering substances, cross-reactivity, and method comparison in the analytical performance reports.
3. Foreign IVDs submit the normative document of the country of origin rather than drafting a local-format version.
4. Prepare the proof of absence of infectious agents separately for every IVD prepared from biological materials.
5. Check the exemption wording item by item: only a joint phrase covering software and in vitro diagnostic devices exempts both.

5. Verification checklist

• □ The item 2.6 normative document has been provided in the correct version for the foreign or domestic manufacturer role
• □ The item 2.11 analytical performance reports cover detection limit, linearity, precision, interference, and cross-reactivity
• □ The item 2.12 proof of absence of infectious agents has been submitted
• □ Items 2.19 and 2.20 labeling and instructions for use have been submitted per the IVD requirements
• □ Exemptions have been checked line by line against the joint wording for software and in vitro diagnostic devices
• □ The analytical performance evidence matches the detection capabilities claimed in the instructions for use

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Uzbekistan, including IVD evidence under items 2.6, 2.11, and 2.12 of Annex 3a and analytical study planning. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.