Monitoring of medical devices in Kazakhstan
Monitoring of medical devices is a set of measures aimed at identifying and preventing adverse events (incidents) associated with the use of medical devices.
All registered medical devices are subject to monitoring.
Monitoring of medical devices is carried out by the National Centre for Expertise of Medicines and Medical Devices (of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan).
What activities include the monitoring of medical devices?
The procedure for monitoring medical devices is carried out in accordance with Order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-320/2020 (ҚР ДСМ-320/2020) dated 23 December 2020 “On Approval of the Rules for Carrying Out Pharmacovigilance and Monitoring the Safety, Quality, and Effectiveness of medical devices”.
Monitoring of medical devices includes the following:
- Analysis of messages received from users and (or) manufacturers of medical devices, in the event of an adverse event, and maintaining appropriate reporting
- Data from post-registration clinical monitoring of the safety and effectiveness of medical devices (only for class 3 medical devices, as well as for class 2b medical devices implanted into the human body)