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Uzbekistan 26/08/2025 Uzbekistan Implements International Standards for Registration of Medicines and Medical Devices

Uzbekistan Implements International Standards for Registration of Medicines and Medical Devices

Tashkent, Uzbekistan (UzDaily.com) — The President of Uzbekistan has signed a decree “On Additional Measures for Regulating the Circulation of Medicines and Medical Devices,” introducing new rules for registration and certification in accordance with international standards.

Under the decree, starting from 1 January 2026, all medical devices and equipment will be registered as medical devices, classified into four safety levels, and allowed on the market only after positive results from clinical trials.

Manufacturers of medicines and medical devices will be required to obtain national certificates of conformity: from 2027, the GMP standard will become mandatory for pharmaceutical products, and ISO 13485 for medical devices.

The decree also establishes a five-year validity period for registration certificates for both domestic and foreign manufacturers. Previously issued indefinite certificates will be limited to this term from the date the decree comes into force.

Contract manufacturing on behalf of rights holders will be allowed if the manufacturer holds a valid license.

At the same time, the requirement for licensing the retail sale of medical devices is lifted — sales will be permitted on a notification basis.

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