Recent regulatory reforms in Uzbekistan have introduced a new framework governing the state registration of medicinal products and medical devices. Under Resolution No. 738 of the Cabinet of Ministers, adopted on 24 November 2025, updated rules will come into force on 26 February 2026. These changes are intended to streamline the registration process while strengthening regulatory oversight, particularly for foreign manufacturers seeking market access.

The revised regime expands and clarifies the documentation required for submission to the competent authority, introduces more precise standards for translations, and establishes defined timelines for each stage of the registration procedure. Together, these measures aim to improve transparency and predictability for applicants, while ensuring that regulatory assessments are completed within clearly prescribed timeframes.

A key requirement under the new provisions is the mandatory appointment of an authorised representative in Uzbekistan by foreign manufacturers of medical devices. Each device may be linked to only one authorised representative, who acts under a power of attorney and serves as the primary interface with regulatory, market surveillance, fiscal authorities and consumers. The role includes post-marketing supervision and ongoing compliance responsibilities. Manufacturers retain flexibility in selecting their authorised representative, which may include a distributor, local representative office, or an independent third party. Where our firm is appointed in this capacity, manufacturers may continue to work with multiple distributors in Uzbekistan, ensuring both regulatory compliance and commercial flexibility.

If you have any inquiries regarding intellectual property matters in Eurasia, please contact us at mail@so-ipr.com.