Tashkent, Uzbekistan
Medical Device Registration in Uzbekistan: Documents, Participants and Typical Workflow
Short answer: Registration in Uzbekistan involves three things working together — document categories (corporate, quality, technical, clinical, labeling), a set of participants (manufacturer, authorized representative, the regulator, specialists/labs, importer/distributor), and a typical workflow that runs from scoping the device to a State Register entry and post-registration duties. There is no single universal document list that fits every device — the exact contents depend on class, type and route — but the categories, roles and sequence below are stable enough to plan around. The framework is Resolution No. 738 (24.11.2025, in force 26.02.2026).
The document categories (not a fixed list)
Rather than a checklist that may not fit your device, prepare by category. Almost every dossier draws from these:
- Corporate / legal documents — manufacturer incorporation, free sale certificate, power of attorney to the authorized representative, and legalized/apostilled corporate papers.
- Quality system evidence — ISO 13485 certificate (or equivalent) covering the relevant manufacturing sites.
- Existing regulatory approvals — CE certificate (with notified-body number), FDA clearance/approval, PMDA, MFDS or MHRA registrations, where held. These may support the recognition route.
- Technical documentation — device description, design and manufacturing information, standards applied, risk management file, and product specifications.
- Clinical / performance evidence — proportionate to the device class and novelty; more for higher-risk and novel devices.
- Labeling and instructions for use — packaging artwork, labels and IFU, brought into Russian/Uzbek per requirements.
- Samples — where local review or testing applies.
Which specific items are required, and in what depth, depends on the device.
The participants and their roles
| Participant | Role |
|---|---|
| Foreign manufacturer | Owns the device and its documentation; makes strategic decisions on scope and route. |
| Authorized representative (in Uzbekistan) | Mandatory. Holds a registered office in Uzbekistan, submits the application, receives the authority's decisions and appears on the State Register. Each device has exactly one. |
| Regulatory authority | The SI "Center for Pharmaceutical Products Safety" under the Ministry of Health, via uzpharm-control.uz, which evaluates the dossier, decides on registration and issues the certificate. |
| Local specialists / laboratories | Handle translations, formalities, expert review and any required testing. |
| Importer / distributor | Handles import and commercial distribution after registration; may also be the authorized representative. |
The typical workflow
Sequence varies by device, but the backbone is consistent:
- Scope and classify the device family, variants and intended use; confirm class and type (IVD, active, equipment, software).
- Choose the route — full registration or recognition route — based on existing approvals and configuration match.
- Appoint the authorized representative with a registered office in Uzbekistan.
- Assemble and translate the dossier by category; legalize/apostille corporate and regulatory documents.
- Submit the application through the authorized representative to the authority.
- Expert review of documentation, with any required local testing or clarification.
- Decision and certificate — on approval, the device receives a registration certificate and a State Register entry. Certificates are commonly valid for a fixed term and must be renewed before expiry.
- Post-registration — import, distribution, labeling compliance, vigilance and renewal planning. Renewal should be initiated well before expiry.
What depends on your specific case
- The exact document contents depend on class, type and route.
- Whether samples/testing are required depends on class, novelty and dossier readiness.
- Who acts as authorized representative depends on your commercial model.
- The timeline ranges from a well-prepared recognition filing (faster) to full registration (several months).
- Renewal windows should be confirmed against the current rules and diarized early.
Typical mistakes to avoid
- Chasing a "definitive document list" instead of preparing by category and confirming specifics for your device.
- Sequencing wrong — starting translations or importing before scope and route are settled.
- Inconsistent entity names across corporate, ISO and regulatory documents.
- Underestimating legalization time for corporate paperwork.
- Forgetting renewal until close to expiry, which risks a gap in market access.
- Treating post-registration duties as optional — labeling, vigilance and renewals are ongoing obligations.
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
- Registration Department — uzpharm-control.uz
- SI "Center for Pharmaceutical Products Safety" — 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
- Medical Device Registration in Uzbekistan: What Foreign Manufacturers Should Prepare Before Starting
- Does CE Marking or FDA Clearance Replace Registration in Uzbekistan?
- How to Find and Check a Distributor in Uzbekistan
Work with UZ NOW
UZ NOW plans the dossier by category, coordinates specialists and labs, and tracks the submission to a State Register entry — through one accountable local lead in Tashkent.
- 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.