Uzbekistan Medical Device Registration: Technical Documentation on Manufacturer, Development and Standards

1. Key takeaways

Annex 3a of Resolution No. 738 splits technical documentation into three information blocks: item 2.3 manufacturer information, item 2.4 development and production information, and item 2.5 the list of applicable standards or common specifications. Item 2.4 must cover technical drawings, the production process flow, critical manufacturing operations, packaging, testing, and the procedure for releasing finished product into free circulation; domestic manufacturers must additionally provide the production regulations. Together this block answers three questions: how the device is designed, how it is manufactured, and how a batch is judged fit for release. For foreign manufacturers, Presidential Decree No. UP-137 of August 19, 2025 adds a relevant dimension, since it permits contract manufacturing of medicines and devices by licensed manufacturers on a contractual basis, which in turn shapes how the production narrative in item 2.4 must be written.

2. Legal basis

3. Expert insights

Insight 1: the manufacturer module must answer who is accountable for quality, especially where production is dispersed. Item 2.3 requires the list of branches and subsidiaries and a copy of the document granting production rights in the country of origin. Where manufacturing activities are spread across several sites or partially outsourced, the file must explain the relationship between the legal manufacturer, each production site, and the party accountable for quality. The purpose of this module is to make the quality responsibility chain explicit, not merely to list a corporate structure. Reviewers use it to decide whom to contact for production questions and which site data govern the conformity claim, so vague or incomplete descriptions here tend to generate follow-up requests that delay the whole case.

Insight 2: the standards list must map line by line to test reports. Item 2.5 requires the list of standards or common specifications and their information. The most common defect in practice is a disconnect between the standards list and the test reports: the list cites a standard, yet the reports contain no corresponding test item. The correct approach is to turn the standards list into a mapping table, where every safety, performance, labeling, and usability requirement is traced to an objective element of evidence within design controls, test reports, risk controls, or verification and validation. This mapping also serves reviewers, because it converts a stack of documents into a readable argument that the device conforms to what the list claims.

Insight 3: contract manufacturing requires the operations and responsibilities to be spelled out. Presidential Decree No. UP-137 permits the rights holder to engage licensed manufacturers to produce medicines and devices under contract. Translated into the dossier, this means the file must state who performs each operation and how product quality responsibility is allocated between the rights holder and the contract manufacturer. General statements that a product is made under contract are not sufficient; the production process narrative in item 2.4 and the site information in item 2.3 must agree with each other and with the underlying agreements, because ambiguous formulations will be questioned during the review of production conditions.

Insight 4: the release procedure is where technical documentation meets the quality system. Item 2.4 requires a description of the procedure for releasing finished product into free circulation. This procedure must reflect both the technical judgment, meaning the criteria on which a batch is released, and the system requirements, meaning who holds release authority and how records are retained. It is one of the few dossier elements that will later be examined both during registration review and during any inspection of production conditions, so drafting it once, carefully, with cross-references to the quality management system pays off twice.

4. Practical recommendations

1. Manage the item 2.5 standards list through a mapping table: standard requirement to corresponding evidence in design controls, test reports, risk controls, or verification and validation.
2. Where manufacturing spans multiple sites or includes outsourcing, open the file with a relationship diagram showing the legal manufacturer, each production site, and the quality responsibility holder.
3. For contract manufacturing, describe the performing entity and the allocation of quality responsibility operation by operation, avoiding summary statements.
4. Draft the release procedure to state both the technical release criteria and the system-level release authority, so it serves registration review and inspections alike.
5. Keep the device name and version wording in the standards list identical to the declaration of conformity and the labeling and instructions for use.

5. Verification checklist

• □ Item 2.3 manufacturer information includes branches, legal address, form of ownership, and the production authorization document
• □ Item 2.4 covers drawings, process flow, critical operations, packaging, testing, and the release procedure
• □ The item 2.5 standards list is presented as a requirement-to-evidence mapping table
• □ Contract manufacturing arrangements state the performing entity and quality responsibility per operation
• □ The release procedure states both the technical criteria and the system authorization
• □ The standards list, declaration of conformity, and test reports use consistent device names and versions

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Uzbekistan, including technical documentation assembly under items 2.3 to 2.5 of Annex 3a and contract manufacturing documentation. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.