Uzbekistan Medical Device Registration: Risk Management and General Conformity Evidence

1. Key takeaways

Annex 3a of Resolution No. 738 divides risk management and conformity evidence into three items: item 2.7 the risk management and analysis report, item 2.9 information on the device’s conformity with the general requirements on safety, effectiveness, labeling, and usability documentation, and item 2.10 the test (verification) and validation reports demonstrating conformity with the general technical requirements. In the current Annex 3a, item 2.10 is a core requirement for all four safety classes. These three items form the argumentation layer of the dossier: the preceding documents describe what the device is and how it is made, while these show why it can be considered safe and effective. Item 2.15, covering adverse event and recall reporting together with the plan for collecting and analyzing post-market safety and effectiveness data, completes the picture by extending the same argumentation into the post-market phase. The practical takeaway is that these items should be drafted together, by one owner, against one risk file, rather than distributed across separate teams working from separate templates.

2. Legal basis

3. Expert insights

Insight 1: the risk management file is not an attachment but the backbone of the dossier. The risk management report under item 2.7 stands in a referencing relationship with the general requirements conformity information under item 2.9 and the verification and validation evidence under item 2.10: the risk analysis identifies which risks exist, the general requirements indicate which controls address them, and the verification and validation reports demonstrate that the controls work. Where the three documents form a traceable chain, the persuasive force of the dossier rises sharply. Where they exist as three unrelated files, reviewers must reconstruct the logic themselves, and every reconstruction step becomes a potential clarification request.

Insight 2: item 2.10 applies to all four classes and cannot be trimmed by class. In the current Annex 3a, verification and validation evidence is marked as required for safety classes I, IIa, IIb, and III alike. This means low-risk devices also need to submit verification and validation evidence, differing only in depth and scope, not in existence. Treating the item as relevant only for high-risk products is one of the most frequent causes of dossier gaps, and the resulting deficiency letter arrives after submission, when the schedule has the least slack to recover.

Insight 3: the general requirements cover four dimensions, and labeling and usability documentation are among them. The wording of item 2.9 includes safety, effectiveness, labeling, and usability documentation. Labels and instructions for use are therefore not only a language matter handled under items 2.19 and 2.20; they are also an object of the conformity argument. Any claim printed on a label, such as a performance statement or an intended use limitation, needs corresponding evidentiary support in the dossier, and claims without support invite review questions or even narrowing of the approved indications.

Insight 4: risk management and post-market surveillance close the loop at the data level. Item 2.15 requires a plan for collecting and analyzing post-market safety and effectiveness data. That plan should connect to the risk management file: the residual risks identified in the risk analysis are precisely the targets of post-market data collection. Aligning the two documents at submission, so that each residual risk appears in the plan with a defined data source and review frequency, avoids rework after approval and positions the holder for a smoother renewal, since the plan’s execution history becomes part of the renewal argument.

4. Practical recommendations

1. Build a risk-to-control-to-evidence traceability matrix so that the item 2.7, 2.9, and 2.10 documents cross-reference each other explicitly.
2. Prepare item 2.10 evidence for all four classes, adjusting depth by class rather than omitting the item for lower classes.
3. Trace every claim in the labeling and instructions for use back to a verification or validation element, and remove unsupported statements.
4. Align the post-market data collection plan with the residual risk list of the risk management file before submission.
5. Keep the terminology of the risk management file consistent with the item 2.15 adverse event reporting format, so post-market reporting inherits the same vocabulary.

5. Verification checklist

• □ The item 2.7 risk management and analysis report has been submitted
• □ The item 2.9 information on general safety, effectiveness, labeling, and usability conformity has been submitted
• □ The item 2.10 verification and validation evidence has been prepared as required for all four classes
• □ A risk-to-control-to-evidence traceability matrix has been established
• □ Labeling and usability claims are traced item by item to verification and validation evidence
• □ The post-market data collection plan is aligned with the residual risk list of the risk management file

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Uzbekistan, including risk management files, conformity evidence under items 2.7 to 2.10 of Annex 3a, and post-market surveillance planning. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.