Uzbekistan Medical Device Definition and Software as a Medical Device Rules

1. Key takeaways

Uzbekistan defines a medical device primarily by its intended use: instruments, equipment, apparatus, systems and software intended for the prevention, diagnosis, treatment, rehabilitation, monitoring or support of physiological functions, and whose principal intended action is not achieved by pharmacological, immunological or metabolic means, qualify as medical devices. Software may constitute a medical device whether it runs independently or in combination with other devices. The correct sequence of judgments is qualification first (is it a device), then classification (which safety class), then route selection (the general route or the recognition route). An error at the qualification stage forces the rework of both later steps. This ordering matters because the definition feeds directly into the scope of mandatory registration established by Presidential Decree No. UP-137 and Cabinet Resolution No. 738: from January 1, 2026, medical-use products and medical equipment are registered uniformly as medical devices, and the separate legacy categories no longer offer an escape route. Borderline products, in particular drug-device combinations, devices incorporating biological material and diagnostic tools prepared from human blood, are qualified by their principal intended mode of action, and that judgment must be documented in the product definition and kept consistent with the intended use stated in the risk management file.

2. Legal basis

3. Expert insights

Insight one: Presidential Decree No. UP-137 unified the qualification approach. From January 1, 2026, the formerly separately managed categories of medical-use products and medical equipment are registered uniformly as medical devices. The practical significance is that the previous practice of relying on the distinction between equipment and device to avoid part of the requirements no longer holds. Product lines that were managed as equipment must be brought back into the registration ledger, and portfolio reviews should identify every SKU whose regulatory status was based on the old split. Companies that delay this reconciliation typically discover the gap only when a customs declaration or a tender document forces the issue.

Insight two: software is qualified by function, not by carrier. Resolution No. 738 requires software-based devices to submit validation and verification results, software architecture and lifecycle information, cybersecurity measures (integrity control, access control, data protection and protection against tampering), identification and marking, manufacturer test results and a compliance tracking system. In the first round of review for a software project, GRZAN compares each functional claim in the marketing materials line by line against the intended use stated in the technical documentation. Claims that run ahead of the documentation are the most common risk at the qualification stage, because the reviewer qualifies the product on the basis of the widest claim available anywhere in the submission.

Insight three: software items enjoy different exemptions across the annexes, and this must not be misread as software being exempt from everything. In the registration dossier format, software development and manufacturing information, normative documents for in vitro diagnostics, sterility information, IVD-specific items, stability studies and labeling and instructions for use are expressly not applicable to software. Cybersecurity, validation and verification and the compliance tracking system, however, remain questions that every software product must answer. What is exempted is the set of irrelevant items, not the entire set, and misreading this distinction produces dossiers with empty sections where content is expected.

Insight four: borderline products are qualified by their principal mode of action. Drug-device combinations, devices incorporating biological material and diagnostic tools prepared from human blood take their qualification from the principal intended mode of action. The basis of the judgment should be written into the product definition statement and kept consistent with the intended use wording in the risk management file. A product qualified as a device at filing but described as a medicine in its brochure invites the reviewer to re-open the qualification question, which is far more expensive than resolving the wording before submission.

4. Practical recommendations

1. Issue a written Product Qualification Statement at the qualification stage, recording the intended use, the principal mode of action and the qualification conclusion, to serve as the consistency baseline for all subsequent documents.
2. For software-based devices, prepare the lifecycle and cybersecurity evidence columns early, since these two columns carry the highest cost when they are supplemented during deficiency responses.
3. Align the functional claims in marketing materials, website copy and instructions for use with the intended use in the technical documentation before any external release.
4. For borderline products, confirm the qualification approach with the authorized representative at the project initiation stage and, where necessary, prepare two sets of evidence.
5. As required by Presidential Decree No. UP-137, re-inventory the product line categories that were managed as equipment and bring them into the registration ledger under the unified approach.

5. Verification checklist

• □ A written Product Qualification Statement has been issued, containing the intended use and the principal mode of action
• □ Software-based devices have prepared validation and verification, architecture and lifecycle, and cybersecurity evidence
• □ The software exemption items in the dossier format have been checked item by item and not misread as a full exemption
• □ Marketing materials and technical documentation state the same intended use
• □ Borderline products containing drugs or biological materials have completed qualification confirmation
• □ Equipment categories in the product line have been brought back into the registration ledger under the unified approach effective January 1, 2026

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with product qualification and software classification, contact info@grzanglobal.com.