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Uzbekistan Medical Device Registration

Primary Regulatory Agency: MoH (Ministry of Health) / CAD (Center for Accreditation and Development)
Official Website: ssv.uz

Important Notes

  • Mandatory State Registration: All medical devices must undergo compulsory state registration with the Center for Standardization of Medicines and Medical Devices under the Ministry of Health, obtaining a Registration Certificate before import and sale.
  • Local Authorized Representative: Foreign manufacturers must appoint a local Uzbek company (typically the importer) as the authorized representative to submit registration, prepare technical documentation, and assume product liability.
  • Technical Documentation & Local Testing: Complete technical documentation in Russian or Uzbek is required. Most medical devices (especially Class II/III) must undergo mandatory local quality control and safety testing in accredited Uzbek laboratories.
  • Price Registration & Control: All registered medical devices must be registered with the state pricing authority and are subject to government price control. Any subsequent price change requires re-approval.
  • Labeling & Language: Product labels and instructions must be in Uzbek and/or Russian, containing full local representative info, registration number, production date, expiry date, and storage conditions.
  • GMP Compliance Certificate: Registration of certain medical devices requires a GMP compliance certificate for the manufacturing site issued by a body recognized by the Uzbek Ministry of Health.

Uzbekistan Specific Requirements

  • Rapidly Reforming Regulatory Landscape: Uzbekistan is actively reforming its medical device regulation to align with international standards, but processes remain highly administrative and centralized.
  • Government-Driven Procurement Market: State procurement programs (e.g., national healthcare plans) are key market drivers, making relationships with the Ministry of Health and major state-owned distributors critical.
  • Import Dependence & Localization Trend: The market is heavily import-dependent, but the government is pushing "import substitution" policies, incentivizing local production with tax benefits.
  • Traditional Adherence to Russian-Sphere Standards: Technical standards and regulations are historically influenced by Russian and former Soviet systems, sharing similarities with Russian registration pathways.
  • Potential Regional Hub: As Central Asia's most populous country, Uzbekistan is seen as a potential gateway to the region, though distribution logistics infrastructure is still developing.

Medical Devices Registration

Regulatory Requirements

  • Uzbekistan National Registration Certificate
  • Technical Documentation in Uzbek Language
  • Classification Management by Risk Level (Class I, II, III)
  • Clinical Evaluation Report (local clinical data required for high-risk)
  • Quality Management System Evidence (ISO 13485)
  • Certificate of Free Sale (CFS) from Country of Origin
  • Product Labeling and Instructions in Uzbek
  • Local Authorized Representative (must be in Uzbekistan)

Main Process

  • Product Classification Determination
  • Prepare Uzbek Technical Documentation
  • Appoint Local Authorized Representative
  • Submit Registration Application to MoH/CAD
  • Technical File Review and Sample Testing
  • Expert Committee Evaluation
  • Obtain National Registration Certificate

Registration Timeline

9-24 months

Official Fees

Approx. 15-80 million UZS

Service Fees

$18,000 - $90,000

Regulatory System Overview

MoH

Ministry of Health of Uzbekistan

The supreme health authority responsible for medical device registration approval, quality supervision, and market regulation.

CAD

Center for Accreditation and Development

Specialized technical body under MoH responsible for technical review, document examination, and registration processing of medical devices.

Expert Committee

MoH Expert Review Committee

Multidisciplinary expert review body responsible for technical evaluation and registration decisions for high-risk medical devices.

Medical Devices Registration Process

1

Product Classification

Determine medical device risk class (I,II,III) per Uzbekistan regulations

2

Technical File Preparation & Translation

Prepare complete technical documentation and translate/certify into Uzbek

3

Clinical Data Preparation

Prepare clinical evaluation report; Class III typically requires local clinical data

4

Appoint Local Representative

Sign agreement with Authorized Representative in Uzbekistan

5

Registration Application

Submit registration application to CAD under MoH for technical review