The procedure is carried out in accordance with Article 261 of the Code on Public Health and Healthcare System of the Republic of Kazakhstan, pursuant to which the competent authority ensures the operation of the vigilance system and monitoring of medical devices.
- Daily monitoring of requests and notifications issued by the expert organization;
- Interaction with competent authorities on behalf of the client;
- Preparation and submission of quarterly and annual reports;
- Support for corrective actions and investigations;
- Reduction of regulatory risks and administrative burden on the company.
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Monitoring Process
Authorities Involved
Regulatory Requirements for Medical Device Safety
The following organizations participate in the monitoring process:
- National Center for Expertise of Medicines and Medical Devices RSE on REM (Expert Organization);
- Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan.
Regulatory Framework
4. Corrective Actions and Investigations
Preparation and submission of reports on corrective actions related to medical device safety, as well as support during investigations in the event of adverse incidents associated with the use of a medical device.
Preparation and submission of reports on corrective actions related to medical device safety, as well as support during investigations in the event of adverse incidents associated with the use of a medical device.
3. Annual Reporting to the Expert Organization
Preparation and submission of annual reports to the expert organization in accordance with Order No. KR DSM-320/2020 of the Ministry of Health of the Republic of Kazakhstan (for Class IIb implantable medical devices and Class III medical devices).
Preparation and submission of annual reports to the expert organization in accordance with Order No. KR DSM-320/2020 of the Ministry of Health of the Republic of Kazakhstan (for Class IIb implantable medical devices and Class III medical devices).
2. Quarterly Reporting to the Client
Preparation and submission of reports to the client regarding activities performed during the reporting period.
Preparation and submission of reports to the client regarding activities performed during the reporting period.
1. Daily Monitoring of Expert Organization Notifications
Tracking information and requests published on the official website of the expert organization, as well as timely notification of the client and processing of incoming requests.
Tracking information and requests published on the official website of the expert organization, as well as timely notification of the client and processing of incoming requests.
Monitoring of the safety, quality, and effectiveness of medical devices includes the following activities:
The monitoring procedure is carried out on the basis of the following regulations:
- Order No. KR DSM-320/2020 of the Minister of Health of the Republic of Kazakhstan dated December 23, 2020 On Approval of the Rules for Pharmacovigilance and Monitoring of the Safety, Quality, and Effectiveness of Medical Devices;
- The Code on Public Health and Healthcare System of the Republic of Kazakhstan;
- The Code of Administrative Offenses of the Republic of Kazakhstan (as amended).
Monitoring the safety, quality, and effectiveness of medical devices is a mandatory post-market surveillance process aimed at identifying and preventing risks associated with the use of medical devices within the territory of the Republic of Kazakhstan.
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66 Navoi Street,
Almaty, Kazakhstan
Almaty, Kazakhstan