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Okt 20, 2021 (Newsletter Issue 15/21)
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Procedure for Registration of Medical Devices Simplified

As of June 1, 2021, in accordance with the Presidential Decree of the Republic of Uzbekistan No. UP-6221, dated May 5, 2021, the simplified procedure of State registration for medical devices becomes possible.

Medical devices that have been registered with the following foreign organizations shall be subject to the simplified procedure:

- Food and Drug Administration (FDA), USA
- Bodies authorized to issue the European Certificate of Conformity (CE), European Union
- European Medicines Agency (EMA), European Union
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Ministry of Food and Drug Safety (MFDS), Republic of Korea
- Medicine and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Medical devices and their components certified under the requirements of the above organizations during the State registration in the Republic of Uzbekistan, shall not be tested in vitro and shall be duly registered within 15 working days after filing an application for registration.

Source: Mikhailyuk, Sorokolat & Partners, Ukraine and www.