Medical Device Registration in Uzbekistan: What Foreign Manufacturers Should Prepare Before Starting

Short answer: Before you start, prepare five things: (1) an authorized representative with a registered office in Uzbekistan, (2) a clear definition of the device, its variants and intended use, (3) proof of a quality management system (ISO 13485 or equivalent), (4) your existing approvals (CE, FDA, PMDA, MFDS, MHRA) if any, because they may open a faster recognition route, and (5) labeling and documentation that can be brought into Russian/Uzbek. No device may be imported, distributed or used in Uzbekistan until it has a state registration certificate and an entry in the State Register. This is the single most important fact to plan around.

Registration is currently governed by Resolution of the Cabinet of Ministers No. 738 of 24 November 2025, whose registration rules entered into force on 26 February 2026. It replaced the earlier framework and introduced a recognition (simplified) route for devices already approved by selected reference regulators.

Why preparation matters more than speed

Most delays in Uzbekistan do not happen at the authority — they happen before submission, when a manufacturer discovers that a certificate is missing, that a document names the wrong legal entity, or that the "device" is actually a family of several configurations that each need their own treatment. Getting the inputs right before the clock starts is the difference between a predictable timeline and repeated resubmission.

What to prepare before you start: a practical checklist

Work through this list before you contact the authority or commit to a timeline.

1. Appoint an authorized representative. A foreign legal manufacturer must appoint an Authorized Representative of the Manufacturer with a registered office in Uzbekistan. This party submits the application, receives the authority's decisions and appears on the State Register. A distributor, a representative office, or a third party may act in this role — but each device is tied to one authorized representative only, so decide deliberately.
2. Define the product scope precisely. List the device name, model/catalogue numbers, accessories, variants, sterile vs. non-sterile versions, and intended use exactly as they appear in your technical file. Under- or over-scoping the application is a common cause of rework.
3. Confirm the classification. Determine the risk class and whether the product is an active device, an in-vitro diagnostic (IVD), or medical equipment, because the pathway and evidence depend on it.
4. Gather your existing approvals. Collect valid CE certificates (with notified-body number), FDA clearance/approval, PMDA, MFDS or MHRA registrations. These do not replace Uzbek registration, but they may qualify the device for the recognition route and reduce local testing.
5. Prove your QMS. Have a current ISO 13485 certificate (or equivalent) ready, matching the manufacturing sites named in the dossier.
6. Assemble manufacturer documents. Free sale certificate, declaration of conformity, manufacturing/quality documentation, instructions for use, labels and packaging artwork.
7. Plan translations and legalization. Budget time for certified translation into Russian/Uzbek and for legalization/apostille of corporate and regulatory documents. This is routinely underestimated.
8. Plan for samples and testing. Depending on class, route and dossier readiness, local review or testing may be required. Confirm this early rather than assuming it away.
9. Map the commercial chain. Decide who the importer and distributor will be, because registration and market access are linked, and the authorized representative decision often follows from the commercial model.

What depends on your specific case

There is no universal document list that fits every device, and it would be misleading to publish one. What changes case by case:

• Device class and type (IVD, active, implantable, software, equipment) drive the depth of evidence.
• Whether you qualify for the recognition route depends on holding an eligible approval for the same configuration from a recognized regulator.
• Local testing requirements vary with class, novelty and dossier completeness.
• Timelines differ substantially: full registration commonly runs several months, while a well-prepared recognition filing can be materially faster.
• The right authorized representative depends on whether you plan to sell through a distributor, a local company or a representative office.

Because of this, the honest starting point is an assessment of your product family — not a copied checklist.

Typical mistakes to avoid

• Assuming CE or FDA is enough. It is supporting evidence, not a market authorization in Uzbekistan. See: Does CE Marking or FDA Clearance Replace Registration in Uzbekistan?
• Choosing the authorized representative carelessly. Because a device can have only one, an ill-considered choice is hard to unwind and can trap you with an underperforming partner.
• Treating a product family as a single device, then discovering mid-process that variants need separate handling.
• Starting translations too late, so an otherwise ready dossier waits on paperwork.
• Naming inconsistent legal entities across the free sale certificate, ISO certificate and application.
• Importing before registration. Nothing may be imported, distributed or clinically used before the State Register entry exists.

Official sources

• Resolution of the Cabinet of Ministers No. 738 of 24.11.2025 (in force 26.02.2026) — lex.uz
• State Register of Medicines and Medical Products — uzpharm-control.uz
• SI "Center for Pharmaceutical Products Safety" under the Ministry of Health — uzpharm-control.uz
• Registration Department — uzpharm-control.uz
• National legal database — lex.uz

Always confirm current requirements against the primary sources above or with a qualified local specialist; regulations change.

Related reading

• Does CE Marking or FDA Clearance Replace Registration in Uzbekistan?
• Medical Device Registration in Uzbekistan: Documents, Participants and Typical Workflow
• Entering Uzbekistan: Local Company, Distributor or Representative?

Work with UZ NOW

UZ NOW coordinates medical device registration for foreign manufacturers through one accountable local lead in Tashkent — pathway assessment, dossier planning, specialist liaison and submission tracking.

• Service: Medical device registration in Uzbekistan
• Get in touch: Contact UZ NOW

Author: Maxim Korovkin, UZ NOW (Tashkent). Published 15 July 2026 · Updated 15 July 2026.