#Legal_news

Procedure for conducting clinical trials of medical devices has been established

The regulation “On the procedure for conducting clinical trials of medical devices” has been state-registered by the Ministry of justice (registration number: 3746, 07.01.2026).

🔰 According to the regulation, the following medical devices shall be state-registered without clinical trials, including:

🔹 medical devices belonging to class I according to safety classification;

🔹 “In vitro” diagnostic medical devices prequalified by the World Health Organization or registered in cooperation with the World Health Organization;

🔹 medical devices for which clinical trials have previously been conducted in the Republic of Uzbekistan.

🏛 The decision to conduct clinical trials is made by the Expert Council established by the Ministry of health of the Republic of Uzbekistan based on the recommendation of the Center.

📜 Clinical trials shall be conducted with the involvement of at least 20 clinical trial subjects, depending on the safety level of the medical device.

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