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MD monitoring and site inspection, how are they related?
Dear partners and colleagues!
We are pleased to inform you that according to Order No. KR DSM-320/2020 of the Minister of Healthcare of the Republic of Kazakhstan dated December 23, 2020 "On Approval of Rules for Pharmacovigilance and Monitoring of Safety, Quality, and Effectiveness of Medical Devices», Order No. 421 of the Minister of Healthcare and Social Development of the Republic of Kazakhstan dated May 29, 2015 "On Approval of Rules for Pharmacovigilance and Monitoring of Safety, Quality and Effectiveness of Medical Devices" became inoperative, and further work on pharmacovigilance and monitoring of safety, quality and effectiveness of medical devices (hereinafter referred to as MD monitoring) will be carried out according to the new Order No. KR DSM-320/2020.
The basic MD monitoring processes remain unchanged, but please note the following requirements:
Under Order No. KR DSM-320/2020, in case of an adverse event, an investigation shall be carried out by the manufacturer and the authorized representative under the supervision of a state expert organization. In the process of investigation, depending on the severity of the adverse event that has occurred, the public authority may decide, under the new Order of the Minister of Healthcare of the Republic of Kazakhstan No. KR DSM-315/2020 of 23 December 2020 "On Approval of Rules for Inspection of Medical Devices", to conduct an unplanned inspection by visiting the medical device manufacturing facility. The inspection covers sites carrying out both full and partial (prepackage, packaging, and labeling) cycles in the manufacturing of a medical device.
Forms of unannounced inspections:
when conducting investigations relating to the safety and efficacy of a medical device;
when it is necessary to confirm that the causes that have led to the production of substandard medical devices have been eliminated.
Rules for inspection of medical devices are approved by Order No. KR DSM-315/2020 of the Minister of Healthcare of the Republic of Kazakhstan dated 23 December 2020 "On Approval of Rules for Inspection of Medical Devices". According to the approved rules, the expert organization shall send a notification to the applicant before the inspection on the need for a manufacturing inspection.
The organization and conduct of the inspection shall not exceed 120 calendar days from the date of notification.
In the meantime, you are required to provide feedback to the state examining authority with the relevant documents within 30 calendar days of receipt of the notification of the inspection.
If you have any questions, please contact your MedExpert manager! We will always be glad to help!
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