A new draft order of the Ministry of Health of the Republic of Kazakhstan on amendments to the Rules for conducting pharmacovigilance and monitoring the safety, quality and effectiveness of medical devices, approved by the order of the Minister of Health of the Republic of Kazakhstan dated 23.12.2020 No. ҚР ДСМ-320/2020, has been published on the Open RLA portal.
The Ministry has developed this document in order to improve the safety of life and health of the population.
The project provides for monitoring the safety, quality and effectiveness of not only the medical device, but also the software included in the medical equipment.
Today, monitoring is aimed at identifying and preventing adverse events associated with the use of a medical device without taking into account the software.
New changes are being made in connection with the trends in the use of modern software in medical devices.
Public discussion of the project will last until November 29, 2024.
You can read the project at the link:
https://legalacts.egov.kz/npa/view?id=15293621
.jpeg)