A large-scale reform aimed at fundamentally improving the system for handling medical devices and equipment in the Republic of Uzbekistan has been announced. This was reported by Upl.uz.
According to the President's decree dated August 19, 2025, a new procedure will be introduced in the country starting from January 1, 2026. This procedure is adapted to international standards and serves to significantly enhance safety and quality standards in the healthcare sector.
As a central element of the reforms, the mandatory state registration of all medical products has been established. Within this process, products are classified into four categories based on their potential risk level to human life and health.
This approach allows differentiation and control of products ranging from simple consumables to complex high-tech equipment requiring special supervision. One of the important requirements of the reform is that state registration of medical products will only be carried out after a positive conclusion is obtained from clinical trial results.
This measure prevents the emergence of products on the market whose safety and effectiveness have not been proven, allowing only tested products to be authorized. Additionally, significant changes will be introduced for manufacturers.
Starting from January 1, 2027, obtaining a national GMP certificate will be mandatory for all enterprises producing medicines. This certificate confirms compliance with “Good Manufacturing Practice.”
For manufacturers of medical equipment, the ISO 13485 standard will also be required starting from July 1, 2027. These steps are considered necessary for the integration of the local pharmaceutical industry into the global market and to increase trust in Uzbek products.
The reform strengthens liability for violations in the pharmaceutical sector. Previously, measures were announced to revoke licenses from pharmaceutical companies and pharmacy chains that sold counterfeit or improperly labeled medicines.
Furthermore, from July 1 of this year, imported medicines can only be sold by official importer companies or their authorized dealers. These measures demonstrate the aim to establish systematic order in the pharmaceutical market and protect citizens' health.
The ISO 13485 standard is mandatory for medical equipment manufacturers in Uzbekistan and is based more on the standardization and control of the manufacturing process than on the final product quality. This allows minimizing risks throughout the processes from design to disposal.
