Spotlight on recent regulatory changes in Uzbekistan
£79.00
A timely overview of Uzbekistan’s updated regulatory framework, including streamlined approval routes and alignment with international standards
English
Content summary:
This article provides a timely overview of Uzbekistan’s newly enacted framework for the state registration of medical devices and equipment under Resolution No. 738, effective February 2026. It outlines the broadened definitions of medical devices, in vitro diagnostics, and standalone software, alongside a risk-based classification system aligned with international practice.
The piece highlights two regulatory pathways: standard registration and a streamlined recognition route for products approved by leading global authorities, offering strategic insights for market entry. It further details documentation requirements, inspection and ISO 13485 compliance expectations, and differentiated timelines based on device class, while clarifying exemptions and special import provisions. The article also examines post-registration obligations, including variations, renewals, and state register inclusion, positioning Uzbekistan as an increasingly structured and internationally harmonised regulatory environment for the medical technology industry.
Specification:
11 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2026 issue of the Journal of Medical Device Regulation.
