Simplified procedure in Uzbekistan: MSP filed the very first medical device application
We are pleased to announce that on August 6, 2021 Mikhailyuk, Sorokolat and Partners became the first company that has filed an application for registration of medical device under the simplified procedure in Uzbekistan.
The simplified procedure of the state registration of medical devices becomes possible if these medical devices are certified by one of the authorized bodies listed below:
- Food and Drug Administration (USA).
- Bodies authorized to issue a European certificate of conformity (EU).
- European Medicines Agency (EU).
- Pharmaceuticals and Medical Devices Agency (Japan).
- Ministry of Food and Drug Safety (Republic of Korea).
- Medicines and Healthcare products Regulatory Agency (United Kingdom).
Said procedure stipulates examination of the registration dossier only and takes 15 days after concluding the Agreement with the Uzbek Authority and payment of the official fees, while laboratory tests of samples for such medical devices are not carried out.
You can find the updated detailed information on the requirements and time frames for registration of medical devices under the simplified procedure by the following link.
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.