From Dossier to Market: The Complete 2026 Documentation Guide to Medical Device Registration in Uzbekistan

The 2026 regulatory snapshot

The operative framework is Cabinet Resolution No. 738 of 24 November 2025, which entered into force on 26 February 2026. It assigns registration to the Ministry of Health's State Institution "Center for Pharmaceutical Product Safety" (the Center), divides devices into Classes I, IIa, IIb, and III, provides general and recognition pathways, and sets a five-year term for the registration certificate.

A second source is already published but was not yet effective on the article's review date: Instruction No. 3888 on documentation requirements enters into force on 8 October 2026. It does not replace the core Appendix 3 list; it explains how the documents should be prepared and what specific content many of them must contain. Teams filing on or after that date should build to the more detailed standard now.

This article states the law as reviewed on 31 August 2026. The supplied English checklist was used as the dossier map, but the Uzbek official texts control. Forms, fees, portal mechanics, and regulator practice can change; confirm them with the Center immediately before filing.

1. 01
   26 February 2026

   Risk-based framework takes effect

   Resolution No. 738 introduces four classes, general and recognition pathways, electronic submission, and five-year certificates.

2. 02
   31 August 2026

   This guide's review point

   The official Uzbek texts available on this date control the analysis in this article.

3. 03
   8 October 2026

   Detailed document instruction takes effect

   Instruction No. 3888 adds more specific content and preparation requirements for many dossier documents.

1. Classify first—then map the evidence triggers

The Appendix 3 matrix can look deceptively uniform because most rows carry a plus sign for every class. The biggest class-based difference is the clinical efficacy and safety report. The bigger practical differences often come from the device itself: a sterile Class I device can demand more evidence than a simple non-sterile Class I device, while software and IVDs replace several physical-product documents with specialized evidence.

Base statutory review periods are 60 working days for Class I, 90 working days for Class IIa, and 120 working days for Classes IIb and III. A clinical efficacy and safety report is required for Classes IIa, IIb, and III. It is generally not required for Class I, except for sterile, measuring, and invasive Class I devices. Time used to cure deficiencies, verify foreign certificates, conduct clinical studies, or complete production inspection is excluded from these periods.

Those answers become the dossier applicability matrix. Every item should be marked required, not applicable with a reason, already available, to be localized, or to be generated. The regulation allows absent information to be addressed only through a reasoned official explanatory letter. A blank cell is not a waiver.

• What is the Uzbek risk class: I, IIa, IIb, or III?
• Is the product standalone or embedded medical software?
• Is it an in vitro diagnostic device, and does it contain biological material?
• Is it sterile, measuring, or invasive?
• Does it have a shelf life, medicinal constituent, human- or animal-origin material, or reusable components?
• Will the application follow the general route, the recognition route, or a WHO-prequalification route?

2. Establish the applicant, representative, and filing authority

The file begins with the application in the prescribed Appendix 2 form. The applicant may be the developer, manufacturer, registration-certificate holder, or a legal entity acting for one of them under a power of attorney. If a representative files, the power of attorney must be notarized, apostilled, or consular-certified.

Instruction No. 3888 adds a practical rule from 8 October 2026: if a foreign manufacturer's power of attorney is drafted in a language other than Uzbek, Karakalpak, Russian, or English, the accuracy of its Uzbek translation must be notarized. The instrument should identify the correct legal entities, signatory authority, device or portfolio scope, permitted actions, and validity period. Names should match the application, quality certificate, free-sale evidence, and labeling exactly.

Resolution No. 738 requires the registration documents to be uploaded to the Center's information system as separate electronic files, in the sequence set out in Appendix 3, and confirmed with the applicant's electronic digital signature. Samples are delivered directly to the Center under controlled storage and transport conditions unless a stated exception applies.

Samples are generally not required for devices registered by recognition or for ordinary Class I devices, but the Class I exception does not cover sterile, measuring, or invasive devices. Reference standards, control materials, special reagents, test strains, diagnostic systems, and manufacturer-specific consumables may also be required for testing, except under the recognition route.

Create a single identity sheet before filing: legal manufacturer, certificate holder, applicant, representative, every production site, device name, model and modification, intended use, risk class, GMDN, UDI, software version, shelf life, and storage conditions. Use that sheet to quality-check every dossier component.

3. Build the core technical dossier

The technical documentation is the largest dossier layer. It should read as one traceable argument: this is the device; this is how it is designed and made; these are the applicable requirements and risks; these tests show conformity; and this is how the device will be labeled, used, and monitored.

Provide the device's field and intended scope of use, concise description, types or variants, and descriptions of the device and its components. Include the GMDN code and UDI where available. From 8 October, Instruction No. 3888 expressly expects a single GMDN code and a single UDI code to be stated for the device where those identifiers exist.

The manufacturer module should cover the manufacturer's name, activity, legal address, ownership form, management structure, status, and authority, together with relevant divisions and subsidiaries. Attach a copy of the home-country document authorizing manufacture where such a document exists. If manufacturing is split across sites or outsourced, explain the relationship among the legal manufacturer, each production site, and the party responsible for quality.

Include technical drawings, the production-process flow, the main manufacturing stages, packaging, testing, and the procedure for release of finished product into free circulation. Domestic manufacturers also provide the production regulation required by the checklist. For contract manufacturing, show who performs each operation and how responsibility for product quality is allocated.

List the standards or general specifications with their full titles, identifiers, and editions. Link each applicable safety, performance, labeling, and use-documentation requirement to a design control, test report, risk control, validation, or other objective evidence. The declaration of conformity and standards list must use the same device names and versions as the test reports.

Provide the risk-management and analysis report, evidence of conformity with the general safety and performance requirements, and the test reports, verification, and validation information used to prove compliance with general technical requirements. The supplied English table left the class-applicability cells blank for item 2.10; the current official Appendix 3 marks verification and validation evidence as required for all four classes. Treat it as a core requirement.

Depending on device characteristics, the file should address electrical safety and electromagnetic compatibility for active devices; biological compatibility and safety for patient-contacting devices; sterility and endotoxins for sterile products; and accuracy, sensitivity, measurement range, mechanical strength, radiation safety, and metrological verification where relevant.

4. Add the product-triggered evidence modules

The core dossier is only the starting point. The following modules are triggered by product characteristics, and the exemptions must be read narrowly.

Medicinal constituents: if the device contains a medicine, describe its composition and quantity, compatibility with the device, and registration status in the country of manufacture. The checklist expressly exempts software and IVDs from this paragraph; it does not create a general exemption for other combination products.

Sterile devices: provide the sterilization method and process validation, bioburden results, bacterial endotoxin data, sterility test methods where necessary, and packaging validation. Connect the sterilization process, sterile-barrier system, transport, and shelf-life claims. Software and IVDs are exempt from this specific paragraph.

In vitro diagnostic devices: a foreign IVD requires the specified regulatory document; a domestic IVD requires a draft normative document. Add reports on specificity and sensitivity and, where the IVD is made from biological material, clear evidence that infectious agents are absent. The checklist exempts IVDs from the medicinal-constituent, sterilization, and general biological-effects paragraphs while imposing these IVD-specific modules.

Medical software and cybersecurity: provide final-version verification and validation results, architecture and lifecycle information, cybersecurity controls, identification and labeling, manufacturer test results, and the system used to monitor continued conformity. Cybersecurity evidence should cover integrity, access control, data protection, and prevention of unauthorized interference, with traceability to identified hazards and software requirements.

The checklist exempts software from the physical-product evidence in items 2.2, 2.4, 2.6, 2.8, 2.11, 2.12, 2.14, 2.16, 2.17, and 2.19, and from product photographs and catalogues under item 6. Software still requires a reasoned treatment of device identity, risk management, software V&V, clinical evidence where applicable, QMS, conformity, market authorization, inspection evidence, and user instructions.

Stability and shelf life: for products with a shelf life, provide the stability-study report, with test results and conclusions translated into the state language. The study should support chemical and physical stability over the claimed period, including test conditions, lots, dates, methodology, results, acceptance criteria, and, when relevant, open-vial or in-use stability. For reusable or active products without a conventional expiry date, service-life or accelerated-aging evidence may be appropriate.

Biological effects and biosafety: where the device contacts the patient or uses biological material, provide biological-effect evaluation test reports and biosafety information. Address device-specific endpoints such as biocompatibility, toxicity, sensitization, and degradation effects, plus sourcing, donor controls, collection, processing, storage, testing, and validated measures used to reduce biological risks. Software is exempt from both paragraphs; IVDs are exempt from the general biological-effects paragraph but have their own biological-material requirements.

Do not delete a checklist row because it seems irrelevant. Keep the row in the index, mark it not applicable, cite the device characteristic that makes it inapplicable, and provide the reasoned explanatory letter allowed by the regulation when required.

5. Clinical evidence, vigilance, and post-market planning

Classes IIa, IIb, and III require a report proving clinical efficacy and safety. Ordinary Class I devices are shown as exempt in the matrix, but sterile, measuring, and invasive Class I devices are expressly carved out of that exemption. The report should synthesize positive and negative clinical data, current scientific literature and other official sources, and experience with the device or a demonstrably equivalent device.

A foreign clinical evaluation should be internally consistent with the intended use, claims, indications, contraindications, risk file, and IFU submitted in Uzbekistan. It should not rely on a broader or differently named device family without a defensible equivalence analysis.

Provide the known adverse-event and withdrawal history: the reporting period, concise descriptions, counts by event type, and the manufacturer's corrective or coordination plan where available. Newly developed and newly designed devices do not provide a historical event-and-withdrawal record, but a forward-looking plan for collecting and analyzing post-registration safety and performance data should still be prepared.

The post-market plan should assign owners and timeframes to the technical and organizational controls associated with each identified risk. Uzbekistan's 2026 vigilance framework also requires responsible personnel to report adverse events or reactions to the Center in the prescribed manner.

6. Localize labeling, packaging, and instructions for use

Submit color label and packaging mock-ups with dimensions. The official wording currently says "13–18 cm"; it should not be silently converted into a 13 × 18 cm format without confirmation from the Center. For foreign manufacturers, the marking text is presented in the state language and in Russian or English. Software is exempt from this packaging-mock-up row.

From 8 October 2026, the detailed instruction specifies core label content: device name and trademark, set contents where relevant, manufacturer and complete legal address, country and production site where applicable, production date, expiry date, storage conditions, lot or serial number, the word STERIL and sterilization method for sterile products, a conformity mark, single-use status, and use restrictions.

The IFU or operating manual is required in the state language and in Russian or English. It should cover device identity, manufacturer and site, intended use, method of use, contraindications and warnings, storage and shelf life, sterility and single-use status, reprocessing for reusable products, components, compatibility and connections, transport, installation, commissioning, operation, disposal, warranty, electrical or radiation safety where relevant, and adverse effects or precautions.

The checklist does not say that every dossier page must be translated into Uzbek. It expressly addresses the power of attorney, stability results and conclusions, labels and packaging, the IFU or manual, and the export certificate. Separate express translation rules from internal best practice and verify certification requirements before submission.

7. Complete the quality, market, and legal evidence

Provide a complete, current copy of the manufacturer's ISO 13485 quality-management-system certificate, issued by an accredited certification body. Check its scope, manufacturing sites, covered product categories, expiry date, and annexes.

Also provide the production-study or inspection report. Do not treat the foreign ISO certificate and the Uzbek production assessment as interchangeable. Under Resolution No. 738, production conditions are assessed against Uzbekistan's national standard harmonized with ISO 13485. Except for recognized devices and qualifying WHO-prequalified IVD routes, inspection may run in parallel with registration, but the national conformity certificate must be available before registration is completed.

The declaration of conformity should address the safety and performance requirements and identify the manufacturer, device name, model, type, intended use, and applicable technical standards. Submit complete, unchanged, and legible pages. The product identity must match the application and certificate evidence exactly.

Provide the home-country registration certificate or another document confirming lawful registration or circulation, such as a free-sale certificate or export certificate, together with the required state-language translation. A copy of registration evidence from another country may also support the dossier. For recognition, maintain clear proof that the foreign authorization is valid and covers the exact device, models, and sites submitted in Uzbekistan.

Product photographs should show the device's appearance, components, consumables, and materials, supported by catalogues where relevant. Software is exempt from this item. Image labels, model numbers, and accessories should agree with the application and technical file.

For trademarks and industrial designs, the current Appendix 3 requests the protection document or use agreement where available. The supplied English checklist also mentions an authorized intellectual-property body's opinion on the trade name and design, and Instruction No. 3888 will expressly recognize that opinion as an alternative from 8 October 2026. Confirm the most suitable evidence with the Center during the transition.

8. Turn the list into a submission-ready dossier

1. 01

   Freeze the product scope. Define the device, models, modifications, accessories, consumables, software versions, intended use, and every manufacturing site that the certificate should cover.

2. 02

   Confirm class and pathway. Document the Uzbek risk class, any recognition eligibility, and all product-triggered modules.

3. 03

   Appoint the representative. Execute and authenticate the power of attorney early; allow time for apostille, consular certification, and translation.

4. 04

   Build the Appendix 3 gap matrix. Give every requirement an owner, source document, language, version, expiry date, and status.

5. 05

   Assemble the technical evidence index. Cross-reference risk controls, essential requirements, standards, tests, clinical evidence, labeling, and IFU.

6. 06

   Localize controlled documents. Translate only from approved masters, use one terminology glossary, and preserve version control.

7. 07

   Run scientific and administrative quality control. Check signatures, validity, accreditation, legalization, page completeness, legibility, and consistency of names, claims, sites, and dates.

8. 08

   Reconfirm the live rules and file. Verify current forms, fees, portal fields, sample quantities, and post-8 October requirements; then upload each document separately in the prescribed order.

Common dossier failures to prevent

• Treating Appendix 3 as a flat checklist instead of a core dossier plus device-triggered modules.
• Assuming every Class I device is exempt from clinical evidence; sterile, measuring, and invasive Class I devices are not.
• Leaving verification and validation evidence out because item 2.10 was blank in the supplied English matrix.
• Using inconsistent device names, intended uses, models, GMDN codes, UDI codes, software versions, or production sites across documents.
• Listing standards without traceable test reports, acceptance criteria, and risk-control links.
• Submitting an expired ISO 13485 certificate or omitting its scope and annexes.
• Localizing the label and IFU separately so claims, warnings, shelf life, or storage conditions diverge.
• Under-documenting sterilization, stability, IVD analytical performance, biological safety, or software cybersecurity.
• Omitting a non-applicable item without a reasoned explanation.
• Treating the representative power of attorney, inspection evidence, or intellectual-property support as a last-minute formality.

9. Plan for modifications, renewal, and post-registration duties

Appendix 3 allows several modifications of a medical device to be included in one registration certificate. That flexibility does not mean any models can be grouped together. Build a defensible family rationale showing common design, intended use, technology, risk class, manufacturing system, and evidence, and keep the modification list aligned across the certificate application, labels, photographs, and technical file.

The registration certificate is valid for five years. For extension, the application must include conclusions from clinical facilities in Uzbekistan on the device's safety and effectiveness. Renewal preparation should therefore begin early enough to identify suitable local clinical evidence, reconcile changes made during the certificate term, and update post-market data.

During the certificate term, the holder must maintain quality, safety, and performance; notify the Center of changes to the dossier; report known adverse effects; and promptly disclose foreign suspensions, cancellations, recalls, or registration refusals related to quality, safety, or performance. A registration dossier is a lifecycle record, not an archive that closes on approval.

The strongest dossier is not the longest one. It is the one in which every document tells the same, evidence-backed story about the device.

The strongest dossier is not the longest one. It is the one in which every document tells the same, evidence-backed story.

MEDEMBARK editorial team

Frequently asked questions

Conclusion: make the dossier reviewer-ready

Uzbekistan's documentation list is broad, but it is manageable when organized around a stable product identity, a universal technical core, and a set of conditional evidence modules. Start with classification and pathway, localize only controlled final documents, and make every risk, claim, model, and manufacturing site traceable across the application, test reports, certificates, labeling, and IFU.

For teams preparing a filing in late 2026, the practical target is clear: comply with the current Appendix 3 list and design the file to satisfy Instruction No. 3888 before its 8 October effective date. That approach reduces transition risk and gives the Center a dossier that is easier to navigate, test, and defend.