In accordance with legislation (Law “On the circulation of medical products”), medical products are manufactured, sold and used on the territory of the Kyrgyz Republic only if they have passed a state registration procedure. At the same time, only those medical products that are confirmed to be in circulation in the manufacturing country or other countries as medical products and have received a positive expert evaluation with regard to their safety, quality and effectiveness, taking into account the potential grade of risk of using medical products, are subject to registration in the republic.
That is, a medical product undergoes analytical expert evaluation in an accredited laboratory during its registration procedure where the main quality indicator for medical masks is the microbiological purity of a medical product. If the results of the expert evaluation are positive, a registration certificate is issued.
Disposable medical masks are medical products with low-grade potential risk that do not come in contact with blood or inner cavities of a human body and are not subject to batch quality and safety assessment.
However, there is a separate governmental regulation (№359 of 1 August 2018) on monitoring the quality, safety and effectiveness of medical products. If a poor-quality, ineffective or unsafe (causing adverse reactions) medical product is identified, a citizen can send a complaint about the medical product via the official website of the Department of Medicines and Medical Products (DMMP) or fill out an adverse event reporting form.
After receiving a notification, experts investigate the incident.
This can be done in several ways:
- By filling out an online notification form (if you are a medical specialist or a holder of medicine’s registration certificate).
- By calling the DMMP hotline at 0800 800 26 25. The call is free.
- Patients can report an adverse reaction by filling out a pop-up form in the right lower corner on the DMMP website – pharm.kg.