Uzbekistan Medical Device State Registration: uzpharm-control.uz Guide

Quick answer

Uzbekistan requires state registration of medical devices before they are placed on the market. The SI "Centre for Pharmaceutical Products Safety" under the Ministry of Health (MOH) administers registration through uzpharm-control.uz, maintains the public State Register of Medicines and Medical Products, and issues registration certificates. The current framework is anchored in the Law on Medicines and Pharmaceutical Activity and the Regulations on State Registration of Medical Devices adopted under Cabinet of Ministers Resolution No. 738 (24 November 2025), effective 26 February 2026. Foreign manufacturers must appoint a local authorized representative with a registered office in Uzbekistan. Two main pathways exist: general (full) registration and a recognition (simplified) route for devices already approved by selected reference authorities—including FDA (United States), CE-marked devices under EU notified-body review, EMA, PMDA (Japan), MFDS (South Korea), and MHRA (United Kingdom). Registration certificates are valid for five years and must be renewed before expiry. No device may be imported, distributed, or used clinically in Uzbekistan without an entry on the state register.

Who this applies to

This guide applies to:

• Foreign manufacturers exporting medical devices, IVD reagents, or active implantable products to Uzbekistan
• Local manufacturers producing medical devices inside Uzbekistan
• Importers and distributors placing registered devices on the Uzbek market
• Regulatory affairs teams mapping FDA 510(k)/De Novo, EU MDR CE certificates, PMDA Shonin/Ninsho, or other reference approvals to the Uzbek pathway
• Hospital procurement and tender teams verifying state-register status before purchase

Scope covers products defined as medical devices and medical products under Uzbek pharmaceutical legislation—not medicines, unless a combination product is explicitly regulated as a device. If your product is used for diagnosis, prevention, monitoring, or treatment of disease in humans and falls outside drug-only classification, assume Centre oversight unless uzpharm-control publishes a specific exemption.

Regulatory framework: Law on Medicines and Resolution 738

Uzbekistan's medical device market access rests on two pillars:

Resolution 738 modernizes Uzbekistan's device registration system by codifying:

• Application formats and dossier content requirements
• Expert review procedures and timelines
• Recognition route criteria for foreign-approved devices
• Authorized representative obligations for non-resident manufacturers
• State Register publication rules
• Certificate validity, renewal, and variation procedures

Manufacturers already registered under pre-738 rules should confirm transition provisions published on uzpharm-control.uz under Regulatory Documents. Treat 26 February 2026 as the operative date for new applications under the updated Regulations unless the Centre publishes grandfathering notices.

Regulator: Centre for Pharmaceutical Products Safety

The SI "Centre for Pharmaceutical Products Safety" (commonly Uzpharm, portal uzpharm-control.uz) operates under MOH. Its public-facing functions include:

The Centre performs expert evaluation of technical dossiers, confirms conformity with Uzbek requirements, and decides registration outcomes. Unlike some CIS markets with separate device agencies, Uzbekistan consolidates medicines and medical products under one Centre—plan dossier structure accordingly.

State Register of Medicines and Medical Products

Before import or sale, every device must appear on the State Register maintained at uzpharm-control.uz/pages/state-register-of-medicines-and-medical-products.

The register typically displays:

• Registered trade name and INN/device generic name where applicable
• Manufacturer name and country
• Registration certificate number and issue date
• Validity period (five-year cycle under Resolution 738)
• Authorized representative for foreign-origin products

Procurement officers, customs brokers, and distributors should verify register entries before shipment. A foreign CE certificate or FDA clearance letter alone does not substitute for Uzbek state registration.

Registration routes: general vs recognition

Resolution 738 establishes two primary pathways:

General (full) registration

Use when the device lacks eligible reference approval or when the recognition route is unavailable (e.g., new technology without FDA/CE/PMDA precedent in the same configuration).

Full registration typically requires complete design and manufacturing documentation, proof of QMS (ISO 13485 or equivalent), labeling in Uzbek/Russian as required, and clinical evidence proportionate to device class and novelty.

Recognition (simplified) route

Resolution 738 introduces a recognition route for devices already registered or approved by designated reference regulators. Eligible reference systems commonly cited in official summaries include:

Under the recognition route, the Centre accepts reference approval as primary evidence of safety and performance, reducing local clinical data requirements. The applicant still submits:

• Certified copy of reference approval or CE certificate
• Declaration that the Uzbekistan-marketed device is identical to the reference-approved configuration (same model, specifications, manufacturing site, and intended use)
• Labeling and IFU translations
• Authorized representative appointment letter
• ISO 13485 or manufacturing quality certificate

Important: Recognition does not mean automatic registration. The Centre retains authority to reject applications where labeling, intended use, or manufacturing differs from the reference dossier, or where Uzbek-specific requirements (language, electrical standards, sterilization claims) are not met.

Route selection decision tree

Device already approved by FDA, CE NB, EMA, PMDA, MFDS, or MHRA?
  ├─ YES → Same configuration for Uzbekistan market?
  │         ├─ YES → Recognition route (simplified dossier)
  │         └─ NO  → General route (full dossier; reference docs supportive only)
  └─ NO  → General route (full dossier)

Local authorized representative

Foreign manufacturers must appoint an authorized representative (local agent) with a registered office in Uzbekistan. The representative:

• Submits registration, renewal, and variation applications on the manufacturer's behalf
• Receives Centre correspondence and official decisions
• Holds or facilitates access to registration certificates
• Supports post-market obligations including adverse event reporting where applicable
• Acts as the in-country contact for inspections and recalls

Commercial agreements should define: who pays Centre fees, who manages renewals, exclusivity for distribution, and document retention. The representative name appears on the State Register alongside the foreign manufacturer—select a partner with regulatory capacity, not merely an importer invoice entity.

Five-year registration certificate

Under Resolution 738, registration certificates are issued for five years (confirm exact wording in Regulation-2 on uzpharm-control.uz at submission time).

Calendar renewal 12–6 months before expiry for high-volume SKUs. Importers should block shipments if renewal is pending and the certificate has lapsed.

Step-by-step registration workflow

1. Confirm device classification — Map product to Uzbek risk/class categories per Regulation-2; align with GMDN or national nomenclature if required.
2. Appoint authorized representative — Execute power of attorney; register representative details with Centre.
3. Select registration route — Recognition vs general based on reference approvals and configuration sameness.
4. Compile dossier — Technical file, QMS certificate, labeling (Uzbek/Russian), IFU, clinical evaluation, reference approval copies (recognition route).
5. Submit application — File through authorized representative to Centre; pay applicable state fees.
6. Expert review — Respond to deficiency letters within Centre deadlines; supply supplementary tests if requested.
7. Registration decision — Upon approval, verify State Register entry on uzpharm-control.uz.
8. Receive certificate — Confirm five-year validity dates and registered scope match commercial SKU.
9. Import and distribute — Align customs declarations and invoices with registered trade name and certificate number.
10. Plan renewal — Track five-year expiry; prepare renewal dossier with updated QMS, FSC, and post-market data.

Key documents and dossier contents

Registration checklist

• Device scope confirmed under Resolution 738 (not medicine-only product)
• Authorized representative appointed with registered Uzbek office
• Registration route selected: general or recognition (FDA/CE/PMDA/MHRA/EMA/MFDS)
• For recognition route: reference approval covers identical model, specs, site, and intended use
• ISO 13485 certificate current and covers manufacturing site
• Labeling and IFU prepared in Uzbek and/or Russian per Centre requirements
• Free Sale Certificate obtained from country of origin where required
• Application submitted via authorized representative to Centre for Pharmaceutical Products Safety
• State fees paid per current MOH schedule on uzpharm-control.uz
• Deficiency responses submitted within Centre deadlines
• State Register entry verified on uzpharm-control.uz before first import
• Registration certificate received with 5-year validity confirmed
• Import documentation matches registered trade name and certificate number
• Renewal calendar set for year 4–5 of certificate life

Common pitfalls

1. Assuming CE or FDA alone is sufficient — Reference approval supports but does not replace Uzbek state registration and State Register entry.
2. Configuration mismatch on recognition route — Different model number, sterilization method, or software version from the reference dossier triggers full review or rejection.
3. No authorized representative — Foreign manufacturers cannot bypass local agent requirements.
4. Labeling language gaps — English-only labels typically fail Centre review; plan Uzbek/Russian translation early.
5. Expired five-year certificate — Import after lapse is non-compliant even if foreign certificates remain valid.
6. Wrong register search — Medicines and devices share one register; verify the correct product category entry.
7. Ignoring variation rules — Manufacturer or site changes after registration require variation, not silent continuation.
8. Underestimating expert review timelines — Budget extra months for first-in-country submissions and deficiency cycles.

FAQ

Who regulates medical device registration in Uzbekistan?

The SI "Centre for Pharmaceutical Products Safety" under the Ministry of Health regulates state registration via uzpharm-control.uz. It maintains the State Register and issues registration certificates under the Law on Medicines and Pharmaceutical Activity and Cabinet Resolution No. 738 (effective 26 February 2026).

What is Cabinet Resolution 738 and when did it take effect?

Cabinet of Ministers Resolution No. 738, dated 24 November 2025, adopts the Regulations on State Registration of Medical Devices. The regulations entered into force on 26 February 2026, replacing prior device registration provisions and introducing the recognition route for FDA-, CE-, PMDA-, and other reference-approved devices.

Can I use FDA or CE approval instead of full Uzbek registration?

No. FDA clearance or CE marking is supporting evidence, not a market authorization. You must obtain Uzbek state registration and a State Register entry. However, if your device holds eligible FDA, CE (notified body), PMDA, MHRA, EMA, or MFDS approval for the same configuration, you may use the recognition (simplified) route under Resolution 738 to streamline dossier requirements.

Is a local authorized representative mandatory for foreign manufacturers?

Yes. Foreign manufacturers must appoint an authorized representative with a registered office in Uzbekistan to submit applications, receive Centre decisions, and appear on the State Register.

How long is the Uzbek medical device registration certificate valid?

Registration certificates issued under Resolution 738 are valid for five years. Renew before expiry to maintain uninterrupted import and distribution rights.

Where can I verify whether a device is registered in Uzbekistan?

Search the State Register of Medicines and Medical Products on uzpharm-control.uz (English portal available). Confirm certificate number, validity dates, manufacturer, and authorized representative match your supply chain.

What documents are needed for the recognition route with a PMDA- or FDA-approved device?

Typical requirements include: Centre application form, authorized representative letter, certified copy of FDA/PMDA/CE/MHRA approval, declaration of identical configuration, ISO 13485 certificate, Uzbek/Russian labeling and IFU, Free Sale Certificate, and manufacturing site details. Exact lists appear in Regulation-2 attached to Resolution 738 on uzpharm-control.uz.

What happens if I import devices without state registration?

Supply of unregistered medical products violates the Law on Medicines and Pharmaceutical Activity. Consequences may include seizure, fines, cancellation of import permissions, and exclusion from public procurement. Hospital tenders and customs clearance increasingly cross-check the State Register.

Official sources

• Centre for Pharmaceutical Products Safety (Uzpharm): https://www.uzpharm-control.uz/en/
• State Register of Medicines and Medical Products: https://www.uzpharm-control.uz/pages/state-register-of-medicines-and-medical-products
• Regulatory documents (Resolution 738 and Regulations): https://www.uzpharm-control.uz/en/ (Regulatory Documents section)
• Cabinet of Ministers Resolution No. 738 (24 November 2025) — Regulations on State Registration of Medical Devices (verify current PDF on uzpharm-control.uz)