Uzbekistan Medical Device Registration: Testing, Verification and Validation Evidence

1. Key takeaways

Item 2.10 of Annex 3a of Resolution No. 738 requires the submission of test (verification) and validation reports demonstrating conformity with the general technical requirements, and in the current Annex 3a this evidence is required for all four safety classes: I, IIa, IIb, and III. Verification answers whether the device was realized as designed; validation answers whether it meets its intended use. The two reports have distinct roles and cannot substitute for each other. The class determines not whether the evidence is submitted but how deep it goes. Getting this distinction right early keeps the evidence package proportionate and complete at the same time. Supporting elements matter as well: the item 2.5 standards list and declaration of conformity must use the same device name and version as the test reports, and samples are submitted in sufficient quantity for testing, while recognition pathway cases and ordinary class I devices are usually exempt from sample submission. Planning sample logistics early matters, since local laboratory scheduling is often the longest lead-time item in the project.

2. Legal basis

3. Expert insights

Insight 1: verification and validation are two different kinds of proof. Verification, expressed as testing in the regulation, addresses whether the device was realized as designed: whether dimensions, electrical parameters, and software functions match the design outputs. Validation addresses whether the device meets its intended use: whether the clinical objective can be achieved under actual or simulated conditions of use. Submitting a type test report in place of a validation report is the most common evidence mismatch in dossiers, because the two documents often sit in the same folder and carry similar titles. Separating them explicitly, with a cover sheet stating which question each report answers, prevents the reviewer from having to guess.

Insight 2: the class affects the depth of evidence, not its existence. The current Annex 3a marks item 2.10 as required for all four classes. A class I device still needs verification and validation evidence, although the scope may concentrate on key performance characteristics. Reading the requirement as unnecessary for low-risk devices leads to a dossier that is incomplete at first review, and the request to supplement arrives exactly when the applicant can least afford the delay. Budgeting for a proportionate but complete evidence package from the start is cheaper than remediation after a deficiency notice.

Insight 3: report names and versions must match the standards list exactly. The item 2.5 standards list and the declaration of conformity must use the same device name and version as the test reports. This requirement bites hardest on electronic products with fast model iteration, where the test report carries an old version number while the submitted declaration carries a new one. Reviewers treat such mismatches as an open question about what was actually tested, so a version register maintained across the project, updated at every engineering change, is the practical safeguard.

Insight 4: the recognition pathway waives local retesting, not the evidence itself. The recognition pathway typically exempts applicants from local laboratory testing, but the applicant must still submit the testing and verification evidence on which the reference approval was based. The evidence therefore remains in the dossier; only its source changes, from local testing to verifiable foreign testing. This means applicants should obtain the full test reports underlying the reference market approval, together with their accredited laboratory provenance, well before filing, because reconstructing those records after the fact is often impossible or slow.

4. Practical recommendations

1. Manage the evidence in two columns, verification and validation, mapped respectively to design output conformity and intended use fulfillment.
2. Submit item 2.10 evidence for all four classes without exception, adjusting the depth and scope by class instead of omitting the item.
3. Maintain a model and version register to ensure the test reports, standards list, and declaration of conformity all carry the same version number.
4. For recognition pathway cases, submit the foreign testing evidence underlying the reference approval together with a verifiable statement of its source and laboratory accreditation.
5. For active devices, check electrical safety and electromagnetic compatibility coverage item by item; for patient-contacting devices, do the same for biocompatibility evidence.

5. Verification checklist

• □ Item 2.10 verification and validation reports are prepared in two columns (design conformity, intended use fulfillment)
• □ Evidence has been submitted for all four safety classes, with depth adjusted by class
• □ Test reports, standards list, and declaration of conformity use the same device name and version
• □ Recognition pathway cases include foreign testing evidence with a verifiable source statement
• □ Electrical safety and electromagnetic compatibility evidence is covered for active devices
• □ Biocompatibility evidence is covered for patient-contacting devices

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Uzbekistan, including verification and validation evidence planning, standards mapping, and recognition pathway documentation. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.