Uzbekistan Medical Device Registration: DARMON Dossier Structure Under Resolution No. 738

1. Key takeaways

Under Cabinet Resolution No. 738, the state registration dossier for medical devices in Uzbekistan is not a bound paper volume but a set of separate electronic files arranged in the sequence prescribed by Annex 3, uploaded through the DARMON information system and confirmed with the applicant’s electronic digital signature. This format has three direct consequences: the order of the files itself defines the review pathway, every document must be capable of being opened and verified independently, and the electronic signature must be held by a local authorized representative. The previous regime under Resolution No. 213 of March 23, 2018 required the registration file to be bound into two paper volumes with pages numbered by section and signed by the applicant. That structure disappeared when Resolution No. 738, adopted November 24, 2025 and effective February 26, 2026, replaced it. Manufacturers that carry the paper-era mindset of one bound dossier into the new system will expose structural problems at the upload stage, because the DARMON platform expects one file per annex item, not a consolidated scan. Registration Order No. 3888, registered in July 2026 and effective October 8, 2026, further refines how each electronic file must be prepared and filled in.

2. Legal basis

3. Expert insights

Insight 1: the shift from two bound paper volumes to separate electronic files changes the granularity of review. Under Resolution No. 213, the registration file had to be bound into two volumes per Annex 3a with pages numbered by section. Resolution No. 738 instead requires the file to be split and uploaded as separate electronic documents in the Annex 3 sequence. The review granularity therefore becomes finer: any single file can be rejected and returned on its own, without sending back the entire dossier. This is materially different from the paper era, where a defect in one annex could stall a whole volume. It also means applicants should expect item-level deficiency letters rather than volume-level ones, and each individual document must be self-contained, legible, and traceable to the annex item it corresponds to.

Insight 2: the item numbering of Annex 3a doubles as an evidence collection checklist. Annex 3a of Resolution No. 738 runs from item 2.1 (device information, GMDN code, UDI, composition and components) all the way to item 2.20 (instructions for use and national-language texts). In between sit the manufacturer information block, standards lists, risk management, sterility data, software information, labeling artwork, and post-market plans. This list can be used directly as an evidence-collection checklist: each item corresponds to one or more documents, and ticking items off one by one immediately shows whether the dossier is complete. Teams that build their project plan around these item numbers find gaps early, while teams that organize by their own internal conventions usually discover omissions only at submission.

Insight 3: the localization of the electronic signature determines who executes the submission. The dossier must be confirmed with the applicant’s electronic digital signature, and the local e-imzo signature infrastructure is issued only to local tax residents. This technically locks in the conclusion that an overseas manufacturer cannot complete the electronic submission on its own, and it explains why the authorized representative institution was re-established in the framework introduced after August 2025 under Presidential Decree No. UP-137 of August 19, 2025. In practical terms, the representative is not merely a postal address for correspondence: it holds the signing credential, performs the actual upload in DARMON, and receives deficiency notices and decisions. Selecting and contracting the representative early is therefore a scheduling prerequisite, not an administrative afterthought.

Insight 4: item applicability depends on product characteristics and cannot be applied across the board. In Annex 3a, several items are explicitly stated not to apply to software (such as development and production information, certain IVD normative documents, sterility information, and labeling texts), while several other items are explicitly stated not to apply to IVDs, and some items exclude both categories at once. Whether a given item is waived must be judged from the exact wording of that item, not from habit or analogy with other markets. A dossier that omits a required item, or that includes an unnecessary one, both create review friction; the first causes deficiency requests, and the second invites questions about why irrelevant content was submitted.

4. Practical recommendations

1. Build the electronic file directory around the item numbers of Annex 3a, with one independent file per item and the item number included in each file name.
2. Use the item numbers as the evidence-collection checklist and tick every line off before entering the translation and legalization stages, so gaps are caught while documents can still be amended cheaply.
3. Check the item exemptions for software and IVD products first, judging strictly by the wording of each item and not by cross-referencing other markets or product categories.
4. Assign the holding of the electronic signature and the execution of the submission to the authorized representative, and fix both the responsible party and the timing in the project schedule.
5. Complete a cross-item consistency review before the dossier is finalized, focusing on model names, specifications, addresses, and the wording of the intended purpose, since reviewers compare these fields across files.

5. Verification checklist

• □ The electronic file directory has been built on the Annex 3a item numbers, one file per item
• □ Every file name contains the corresponding item number so reviewers can locate it
• □ The evidence-collection checklist has been ticked item by item with no gaps
• □ Item exemptions for software and IVD products have been checked against the exact wording of each item
• □ The responsible party and timing for the electronic signature and submission are fixed
• □ The cross-item consistency review is complete (models, specifications, addresses, intended purpose)

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Uzbekistan, including dossier structuring for the DARMON system, electronic file preparation under Annex 3a, and coordination of electronic signature and submission steps. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.