Uzbekistan will recognize US and EU registered medical devices

Uzbekistan will recognize US and EU registered medical devices

Presidential Decree UP-No. 6221 of 5 May 2021 has introduced a registration recognition procedure for medical devices from June 1, 2021.

Medical devices that have been registered with the following foreign organizations shall be subject to the recognition 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 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 no later than fifteen working days.

Also, the State Customs Committee (Azimov M. B.), together with the Pharmaceutics Development Agency, the Uzstandard Agency, the Commissioner for the Protection of the Rights and Legitimate Interests of Business Entities and the Chamber of Commerce and Industry, shall establish permanent control over the import of medical devices and their components provided for in this paragraph, without allowing unnecessary barriers.

SlideEXPERTS IN EXCIPIENTS

Search engine for pharmaceutical industry resources

Type in a search phrase such as - gmp and get the search result

Don’t miss your daily PharmaProm.Ru news.
SUBSCRIBE free here

SUBSCRIBE
Loading…