On August 19, 2025, the President of the Republic of Uzbekistan adopted Decree No. UP-137. This was reported by Upl.uz.
This document envisages significant changes in the procedure for the registration and circulation of medicines and medical devices. The purpose of the decree is to harmonize national standards with international requirements, enhance product safety, and protect public health.
Starting from January 1, 2026, a new procedure will be introduced for medical devices and medical equipment. From now on, such products will be registered as medical devices and classified into four categories based on their safety level.
State registration will only be carried out after successful completion of clinical trials, which ensures the effectiveness and safety of the product. Additionally, the decree establishes new requirements for certification.
From January 1, 2027, manufacturers will be required to have a national "GMP" — Good Manufacturing Practice certificate for the import and production of medicines. This internationally recognized standard regulates manufacturing and quality control processes.
Similar changes will be introduced for medical devices. From July 1, 2027, manufacturers will be required to obtain an "ISO 13485" certificate to receive certification.
This international standard confirms that the quality management system complies with the requirements for the production of medical devices. These changes will contribute to further strengthening the national healthcare system.
