REGULATORY AUTHORITY: Medical devices are regulated by Uzbekistan’s Ministry of Health (MOH). Metrological and calibration devices require a metrological certificate in addition to the standard registration process.
CLASSIFICATION SYSTEM: Medical Device Classification follows the EU model of risk-based classification into Classes I, IIa, IIb and III.
TIMEFRAME: The Uzbekistan medical device registration process can range between six and nine months, depending on the type of product and whether registration with the metrological committee is required. For Class III devices, this process can take up to a year.
LICENSE VALIDITY: Registration licenses issued in Uzbekistan are valid for 5 years. The additional metrological certificate is valid for 3 years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required.
Other Central & East Asia Countries: Afghanistan, India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Sri Lanka, Taiwan, Tajikistan, Uzbekistan
