STATE CONTROL OF CIRCULATION OF MEDICAL DEVICES. TYPICAL VIOLATIONS DETECTED BY TOXICITY STUDIES OF MEDICAL DEVICES
Abstract and keywords
Abstract (English):
This article dedicated to the issues of state control over circulation of medical devices and typical violations detected by toxicity studies of medical devices. The article reviews the typical violations of mandatory requirements for various subjects of circulation of medical devices. The article specifically covers the reasons for decline of toxicological and sanitary chemical indicators when conducting toxicity studies of medical devices in the framework of state control.

Keywords:
medical device, state control of circulation of medical devices, toxicity studies, safety of medical device, quality of medical device
References

1. Sharikadze D.T., Ivanova T.V., Borisova E.V. Pravovye osnovy monitoringa bezopasnosti medicinskih izdeliy na postregistracionnom etape obrascheniya i rol' medicinskih organizaciy pri ego osuschestvlenii. – Menedzhment kachestva v medicine. – 2018. – № 2. – S. 106–111.

2. Reznichenko S.V., Morozov Yu.L. (red.) Bol'shoy spravochnik rezinschika. Tom 1. Kauchuki i ingredienty. M.: Tehinform, 2012. – 460 s.