Simplified procedure for registration of medical devices in Uzbekistan

In accordance with the Presidential Decree of the Republic of Uzbekistan dated 5 May, 2021 No UP-6221 from June 1, 2021 the simplified procedure of the State registration for Medical devices becomes possible if these medical devices are certified by one of the authorized bodies listed below:

1. Food and Drug Administration, USA
2. Bodies authorized to issue a European certificate of conformity (EU)
3. European Medicines Agency (EU)
4. Pharmaceuticals and Medical Devices Agency (Japan)
5. Ministry of Food and Drug Safety (Republic of Korea )
6. Medicines and Healthcare products Regulatory Agency (United Kingdom)

According to said Decree medical devices and their components approved by one of these authorities shall be registered in Uzbekistan within 15 days after filling an application for registration while laboratory tests of samples for such medical devices are not carried out.

In order we could provide you with the detailed information on the associated costs as well as the exact list of required documents and sample of the Power of Attorney for execution, etc. please contact our specialists from Regulatory Affairs Department.