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Medical Devices-Asia and ROW Regulatory News – April 2023

  1. The establishment does not provide feedback as required within 30 working days; or
  2. Applications are returned by establishments without complete documents or information. Accordingly, the establishment needs to check that the information or documents provided are correct and complete before returning them to the MDA

The use of unregistered medical devices is extremely risky because the safety and performance of the medical device cannot be verified. In relation to that, the public and parties involved are encouraged to check the registration status of a medical device first before purchasing. The check can be made by entering the name, brand, or registration number of the device on the label at the link

This case is also published in the announcement area and the special area of medical device regulations of the FDA’s global information website (


Completed questionnaires must be sent to the email address [email protected] until May 1, 5 of the current year with the note “Questionnaire, organization name”. If any questions, Contact the Department of Medicines and Medical Devices at the Medical Device Registration Office or call 0312 219278.

Regulatory legal acts in the field of regulation of medical devices of the Eurasian Economic Commission are available on the official website of the Eurasian Commission (

Questionnaire link: